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US Dermatologic Drug Approvals Rose Between 2012 and 2022
TOPLINE:
METHODOLOGY:
- Only five new drugs for diseases treated mostly by dermatologists were approved by the FDA between 1999 and 2009.
- In a cross-sectional analysis to characterize the frequency and degree of innovation of dermatologic drugs approved more recently, researchers identified new and supplemental dermatologic drugs approved between January 1, 2012, and December 31, 2022, from FDA lists, Centers for Medicare & Medicaid Services CenterWatch, and peer-reviewed articles.
- They used five proxy measures to estimate each drug’s degree of innovation: FDA designation (first in class, advance in class, or addition to class), independent clinical usefulness ratings, and benefit ratings by health technology assessment organizations.
TAKEAWAY:
- The study authors identified 52 new drug applications and 26 supplemental new indications approved by the FDA for dermatologic indications between 2012 and 2022.
- Of the 52 new drugs, the researchers categorized 11 (21%) as first in class and 13 (25%) as first in indication.
- An analysis of benefit ratings available for 38 of the drugs showed that 15 (39%) were rated as being clinically useful or having high added therapeutic benefit.
- Of the 10 supplemental new indications with ratings by any organization, 3 (30%) were rated as clinically useful or having high added therapeutic benefit.
IN PRACTICE:
While innovative drug development in dermatology may have increased, “these findings also highlight opportunities to develop more truly innovative dermatologic agents, particularly for diseases with unmet therapeutic need,” the authors wrote.
SOURCE:
First author Samir Kamat, MD, of the Medical Education Department at Icahn School of Medicine at Mount Sinai, New York City, and corresponding author Ravi Gupta, MD, MSHP, of the Internal Medicine Division at Johns Hopkins University, Baltimore, Maryland, led the research. The study was published online as a research letter on December 20, 2023, in JAMA Dermatology.
LIMITATIONS:
They include the use of individual indications to assess clinical usefulness and benefit ratings. Many drugs, particularly supplemental indications, lacked such ratings. Reformulations of already marketed drugs or indications were not included.
DISCLOSURES:
Dr. Kamat and Dr. Gupta had no relevant disclosures. Three coauthors reported having received financial support outside of the submitted work.
A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Only five new drugs for diseases treated mostly by dermatologists were approved by the FDA between 1999 and 2009.
- In a cross-sectional analysis to characterize the frequency and degree of innovation of dermatologic drugs approved more recently, researchers identified new and supplemental dermatologic drugs approved between January 1, 2012, and December 31, 2022, from FDA lists, Centers for Medicare & Medicaid Services CenterWatch, and peer-reviewed articles.
- They used five proxy measures to estimate each drug’s degree of innovation: FDA designation (first in class, advance in class, or addition to class), independent clinical usefulness ratings, and benefit ratings by health technology assessment organizations.
TAKEAWAY:
- The study authors identified 52 new drug applications and 26 supplemental new indications approved by the FDA for dermatologic indications between 2012 and 2022.
- Of the 52 new drugs, the researchers categorized 11 (21%) as first in class and 13 (25%) as first in indication.
- An analysis of benefit ratings available for 38 of the drugs showed that 15 (39%) were rated as being clinically useful or having high added therapeutic benefit.
- Of the 10 supplemental new indications with ratings by any organization, 3 (30%) were rated as clinically useful or having high added therapeutic benefit.
IN PRACTICE:
While innovative drug development in dermatology may have increased, “these findings also highlight opportunities to develop more truly innovative dermatologic agents, particularly for diseases with unmet therapeutic need,” the authors wrote.
SOURCE:
First author Samir Kamat, MD, of the Medical Education Department at Icahn School of Medicine at Mount Sinai, New York City, and corresponding author Ravi Gupta, MD, MSHP, of the Internal Medicine Division at Johns Hopkins University, Baltimore, Maryland, led the research. The study was published online as a research letter on December 20, 2023, in JAMA Dermatology.
LIMITATIONS:
They include the use of individual indications to assess clinical usefulness and benefit ratings. Many drugs, particularly supplemental indications, lacked such ratings. Reformulations of already marketed drugs or indications were not included.
DISCLOSURES:
Dr. Kamat and Dr. Gupta had no relevant disclosures. Three coauthors reported having received financial support outside of the submitted work.
A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Only five new drugs for diseases treated mostly by dermatologists were approved by the FDA between 1999 and 2009.
- In a cross-sectional analysis to characterize the frequency and degree of innovation of dermatologic drugs approved more recently, researchers identified new and supplemental dermatologic drugs approved between January 1, 2012, and December 31, 2022, from FDA lists, Centers for Medicare & Medicaid Services CenterWatch, and peer-reviewed articles.
- They used five proxy measures to estimate each drug’s degree of innovation: FDA designation (first in class, advance in class, or addition to class), independent clinical usefulness ratings, and benefit ratings by health technology assessment organizations.
TAKEAWAY:
- The study authors identified 52 new drug applications and 26 supplemental new indications approved by the FDA for dermatologic indications between 2012 and 2022.
- Of the 52 new drugs, the researchers categorized 11 (21%) as first in class and 13 (25%) as first in indication.
- An analysis of benefit ratings available for 38 of the drugs showed that 15 (39%) were rated as being clinically useful or having high added therapeutic benefit.
- Of the 10 supplemental new indications with ratings by any organization, 3 (30%) were rated as clinically useful or having high added therapeutic benefit.
IN PRACTICE:
While innovative drug development in dermatology may have increased, “these findings also highlight opportunities to develop more truly innovative dermatologic agents, particularly for diseases with unmet therapeutic need,” the authors wrote.
SOURCE:
First author Samir Kamat, MD, of the Medical Education Department at Icahn School of Medicine at Mount Sinai, New York City, and corresponding author Ravi Gupta, MD, MSHP, of the Internal Medicine Division at Johns Hopkins University, Baltimore, Maryland, led the research. The study was published online as a research letter on December 20, 2023, in JAMA Dermatology.
LIMITATIONS:
They include the use of individual indications to assess clinical usefulness and benefit ratings. Many drugs, particularly supplemental indications, lacked such ratings. Reformulations of already marketed drugs or indications were not included.
DISCLOSURES:
Dr. Kamat and Dr. Gupta had no relevant disclosures. Three coauthors reported having received financial support outside of the submitted work.
A version of this article appeared on Medscape.com.
Topical ivermectin study sheds light on dysbiosis in rosacea
, according to a report presented at the recent European Academy of Dermatology and Venereology (EADV) 2023 Congress.
“This is the first hint that the host’s cutaneous microbiome plays a secondary role in the immunopathogenesis of rosacea,” said Bernard Homey, MD, director of the department of dermatology at University Hospital Düsseldorf in Germany.
“In rosacea, we are well aware of trigger factors such as stress, UV light, heat, cold, food, and alcohol,” he said. “We are also well aware that there is an increase in Demodex mites in the pilosebaceous unit.”
Research over the past decade has also started to look at the potential role of the skin microbiome in the disease process, but answers have remained “largely elusive,” Dr. Homey said.
Ivermectin helps, but how?
Ivermectin 1% cream (Soolantra) has been approved by the U.S. Food and Drug Administration since 2014 for the treatment of the inflammatory lesions that are characteristic of rosacea, but its mechanism of action is not clear.
Dr. Homey presented the results of a study of 61 patients designed to look at how ivermectin might be working in the treatment of people with rosacea and investigate if there was any relation to the skin microbiome and transcriptome of patients.
The trial included 41 individuals with papulopustular rosacea and 20 individuals who did not have rosacea. For all patients, surface skin biopsies were performed twice 30 days apart using cyanoacrylate glue; patients with rosacea were treated with topical ivermectin 1% between biopsies. Skin samples obtained at day 0 and day 30 were examined under the microscope, and Demodex counts (mites/cm2) of skin and RNA sequencing of the cutaneous microbiome were undertaken.
The mean age of the patients with rosacea was 54.9 years, and the mean Demodex counts before and after treatment were a respective 7.2 cm2 and 0.9 cm2.
Using the Investigator’s General Assessment to assess the severity of rosacea, Homey reported that 43.9% of patients with rosacea had a decrease in scores at day 30, indicating improvement.
In addition, topical ivermectin resulted in a marked or total decrease in Demodex mite density for 87.5% of patients (n = 24) who were identified as having the mites.
Skin microbiome changes seen
As a form of quality control, skin microbiome changes among the patients were compared with control patients using 16S rRNA sequencing.
“The taxa we find within the cutaneous niche of inflammatory lesions of rosacea patients are significantly different from healthy volunteers,” Dr. Homey said.
Cutibacterium species are predominant in healthy control persons but are not present when there is inflammation in patients with rosacea. Instead, staphylococcus species “take over the niche, similar to atopic dermatitis,” he noted.
Looking at how treatment with ivermectin influences the organisms, the decrease in C. acnes seen in patients with rosacea persisted despite treatment, and the abundance of Staphylococcus epidermidis, S. hominis, and S. capitis increased further. This suggests a possible protective or homeostatic role of C. acnes but a pathogenic role for staphylococci, explained Dr. Homey.
“Surprisingly, although inflammatory lesions decrease, patients get better, the cutaneous microbiome does not revert to homeostatic conditions during topical ivermectin treatment,” he observed.
There is, of course, variability among individuals.
Dr. Homey also reported that Snodgrassella alvi – a microorganism believed to reside in the gut of Demodex folliculorum mites – was found in the skin microbiome of patients with rosacea before but not after ivermectin treatment. This may mean that this microorganism could be partially triggering inflammation in rosacea patients.
Looking at the transcriptome of patients, Dr. Homey said that there was downregulation of distinct genes that might make for more favorable conditions for Demodex mites.
Moreover, insufficient upregulation of interleukin-17 pathways might be working together with barrier defects in the skin and metabolic changes to “pave the way” for colonization by S. epidermidis.
Pulling it together
Dr. Homey and associates conclude in their abstract that the findings “support that rosacea lesions are associated with dysbiosis.”
Although treatment with ivermectin did not normalize the skin’s microbiome, it was associated with a decrease in Demodex mite density and the reduction of microbes associated with Demodex.
Margarida Gonçalo, MD, PhD, professor of dermatology at the University of Coimbra in Portugal, who cochaired the late-breaking news session where the data were presented, asked whether healthy and affected skin in patients with rosacea had been compared, rather than comparing the skin of rosacea lesions with healthy control samples.
“No, we did not this, as this is methodologically a little bit more difficult,” Dr. Homey responded.
Also cochairing the session was Michel Gilliet, MD, chair of the department of dermatology at the University Hospital CHUV in Lausanne, Switzerland. He commented that these “data suggest that there’s an intimate link between Demodex and the skin microbiota and dysbiosis in in rosacea.”
Dr. Gilliet added: “You have a whole dysbiosis going on in rosacea, which is probably only dependent on these bacteria.”
It would be “very interesting,” as a “proof-of-concept” study, to look at whether depleting Demodex would also delete S. alvi, he suggested.
The study was funded by Galderma. Dr. Homey has acted as a consultant, speaker or investigator for many pharmaceutical companies including Galderma.
A version of this article first appeared on Medscape.com.
, according to a report presented at the recent European Academy of Dermatology and Venereology (EADV) 2023 Congress.
“This is the first hint that the host’s cutaneous microbiome plays a secondary role in the immunopathogenesis of rosacea,” said Bernard Homey, MD, director of the department of dermatology at University Hospital Düsseldorf in Germany.
“In rosacea, we are well aware of trigger factors such as stress, UV light, heat, cold, food, and alcohol,” he said. “We are also well aware that there is an increase in Demodex mites in the pilosebaceous unit.”
Research over the past decade has also started to look at the potential role of the skin microbiome in the disease process, but answers have remained “largely elusive,” Dr. Homey said.
Ivermectin helps, but how?
Ivermectin 1% cream (Soolantra) has been approved by the U.S. Food and Drug Administration since 2014 for the treatment of the inflammatory lesions that are characteristic of rosacea, but its mechanism of action is not clear.
Dr. Homey presented the results of a study of 61 patients designed to look at how ivermectin might be working in the treatment of people with rosacea and investigate if there was any relation to the skin microbiome and transcriptome of patients.
The trial included 41 individuals with papulopustular rosacea and 20 individuals who did not have rosacea. For all patients, surface skin biopsies were performed twice 30 days apart using cyanoacrylate glue; patients with rosacea were treated with topical ivermectin 1% between biopsies. Skin samples obtained at day 0 and day 30 were examined under the microscope, and Demodex counts (mites/cm2) of skin and RNA sequencing of the cutaneous microbiome were undertaken.
The mean age of the patients with rosacea was 54.9 years, and the mean Demodex counts before and after treatment were a respective 7.2 cm2 and 0.9 cm2.
Using the Investigator’s General Assessment to assess the severity of rosacea, Homey reported that 43.9% of patients with rosacea had a decrease in scores at day 30, indicating improvement.
In addition, topical ivermectin resulted in a marked or total decrease in Demodex mite density for 87.5% of patients (n = 24) who were identified as having the mites.
Skin microbiome changes seen
As a form of quality control, skin microbiome changes among the patients were compared with control patients using 16S rRNA sequencing.
“The taxa we find within the cutaneous niche of inflammatory lesions of rosacea patients are significantly different from healthy volunteers,” Dr. Homey said.
Cutibacterium species are predominant in healthy control persons but are not present when there is inflammation in patients with rosacea. Instead, staphylococcus species “take over the niche, similar to atopic dermatitis,” he noted.
Looking at how treatment with ivermectin influences the organisms, the decrease in C. acnes seen in patients with rosacea persisted despite treatment, and the abundance of Staphylococcus epidermidis, S. hominis, and S. capitis increased further. This suggests a possible protective or homeostatic role of C. acnes but a pathogenic role for staphylococci, explained Dr. Homey.
“Surprisingly, although inflammatory lesions decrease, patients get better, the cutaneous microbiome does not revert to homeostatic conditions during topical ivermectin treatment,” he observed.
There is, of course, variability among individuals.
Dr. Homey also reported that Snodgrassella alvi – a microorganism believed to reside in the gut of Demodex folliculorum mites – was found in the skin microbiome of patients with rosacea before but not after ivermectin treatment. This may mean that this microorganism could be partially triggering inflammation in rosacea patients.
Looking at the transcriptome of patients, Dr. Homey said that there was downregulation of distinct genes that might make for more favorable conditions for Demodex mites.
Moreover, insufficient upregulation of interleukin-17 pathways might be working together with barrier defects in the skin and metabolic changes to “pave the way” for colonization by S. epidermidis.
Pulling it together
Dr. Homey and associates conclude in their abstract that the findings “support that rosacea lesions are associated with dysbiosis.”
Although treatment with ivermectin did not normalize the skin’s microbiome, it was associated with a decrease in Demodex mite density and the reduction of microbes associated with Demodex.
Margarida Gonçalo, MD, PhD, professor of dermatology at the University of Coimbra in Portugal, who cochaired the late-breaking news session where the data were presented, asked whether healthy and affected skin in patients with rosacea had been compared, rather than comparing the skin of rosacea lesions with healthy control samples.
“No, we did not this, as this is methodologically a little bit more difficult,” Dr. Homey responded.
Also cochairing the session was Michel Gilliet, MD, chair of the department of dermatology at the University Hospital CHUV in Lausanne, Switzerland. He commented that these “data suggest that there’s an intimate link between Demodex and the skin microbiota and dysbiosis in in rosacea.”
Dr. Gilliet added: “You have a whole dysbiosis going on in rosacea, which is probably only dependent on these bacteria.”
It would be “very interesting,” as a “proof-of-concept” study, to look at whether depleting Demodex would also delete S. alvi, he suggested.
The study was funded by Galderma. Dr. Homey has acted as a consultant, speaker or investigator for many pharmaceutical companies including Galderma.
A version of this article first appeared on Medscape.com.
, according to a report presented at the recent European Academy of Dermatology and Venereology (EADV) 2023 Congress.
“This is the first hint that the host’s cutaneous microbiome plays a secondary role in the immunopathogenesis of rosacea,” said Bernard Homey, MD, director of the department of dermatology at University Hospital Düsseldorf in Germany.
“In rosacea, we are well aware of trigger factors such as stress, UV light, heat, cold, food, and alcohol,” he said. “We are also well aware that there is an increase in Demodex mites in the pilosebaceous unit.”
Research over the past decade has also started to look at the potential role of the skin microbiome in the disease process, but answers have remained “largely elusive,” Dr. Homey said.
Ivermectin helps, but how?
Ivermectin 1% cream (Soolantra) has been approved by the U.S. Food and Drug Administration since 2014 for the treatment of the inflammatory lesions that are characteristic of rosacea, but its mechanism of action is not clear.
Dr. Homey presented the results of a study of 61 patients designed to look at how ivermectin might be working in the treatment of people with rosacea and investigate if there was any relation to the skin microbiome and transcriptome of patients.
The trial included 41 individuals with papulopustular rosacea and 20 individuals who did not have rosacea. For all patients, surface skin biopsies were performed twice 30 days apart using cyanoacrylate glue; patients with rosacea were treated with topical ivermectin 1% between biopsies. Skin samples obtained at day 0 and day 30 were examined under the microscope, and Demodex counts (mites/cm2) of skin and RNA sequencing of the cutaneous microbiome were undertaken.
The mean age of the patients with rosacea was 54.9 years, and the mean Demodex counts before and after treatment were a respective 7.2 cm2 and 0.9 cm2.
Using the Investigator’s General Assessment to assess the severity of rosacea, Homey reported that 43.9% of patients with rosacea had a decrease in scores at day 30, indicating improvement.
In addition, topical ivermectin resulted in a marked or total decrease in Demodex mite density for 87.5% of patients (n = 24) who were identified as having the mites.
Skin microbiome changes seen
As a form of quality control, skin microbiome changes among the patients were compared with control patients using 16S rRNA sequencing.
“The taxa we find within the cutaneous niche of inflammatory lesions of rosacea patients are significantly different from healthy volunteers,” Dr. Homey said.
Cutibacterium species are predominant in healthy control persons but are not present when there is inflammation in patients with rosacea. Instead, staphylococcus species “take over the niche, similar to atopic dermatitis,” he noted.
Looking at how treatment with ivermectin influences the organisms, the decrease in C. acnes seen in patients with rosacea persisted despite treatment, and the abundance of Staphylococcus epidermidis, S. hominis, and S. capitis increased further. This suggests a possible protective or homeostatic role of C. acnes but a pathogenic role for staphylococci, explained Dr. Homey.
“Surprisingly, although inflammatory lesions decrease, patients get better, the cutaneous microbiome does not revert to homeostatic conditions during topical ivermectin treatment,” he observed.
There is, of course, variability among individuals.
Dr. Homey also reported that Snodgrassella alvi – a microorganism believed to reside in the gut of Demodex folliculorum mites – was found in the skin microbiome of patients with rosacea before but not after ivermectin treatment. This may mean that this microorganism could be partially triggering inflammation in rosacea patients.
Looking at the transcriptome of patients, Dr. Homey said that there was downregulation of distinct genes that might make for more favorable conditions for Demodex mites.
Moreover, insufficient upregulation of interleukin-17 pathways might be working together with barrier defects in the skin and metabolic changes to “pave the way” for colonization by S. epidermidis.
Pulling it together
Dr. Homey and associates conclude in their abstract that the findings “support that rosacea lesions are associated with dysbiosis.”
Although treatment with ivermectin did not normalize the skin’s microbiome, it was associated with a decrease in Demodex mite density and the reduction of microbes associated with Demodex.
Margarida Gonçalo, MD, PhD, professor of dermatology at the University of Coimbra in Portugal, who cochaired the late-breaking news session where the data were presented, asked whether healthy and affected skin in patients with rosacea had been compared, rather than comparing the skin of rosacea lesions with healthy control samples.
“No, we did not this, as this is methodologically a little bit more difficult,” Dr. Homey responded.
Also cochairing the session was Michel Gilliet, MD, chair of the department of dermatology at the University Hospital CHUV in Lausanne, Switzerland. He commented that these “data suggest that there’s an intimate link between Demodex and the skin microbiota and dysbiosis in in rosacea.”
Dr. Gilliet added: “You have a whole dysbiosis going on in rosacea, which is probably only dependent on these bacteria.”
It would be “very interesting,” as a “proof-of-concept” study, to look at whether depleting Demodex would also delete S. alvi, he suggested.
The study was funded by Galderma. Dr. Homey has acted as a consultant, speaker or investigator for many pharmaceutical companies including Galderma.
A version of this article first appeared on Medscape.com.
FROM EADV 2023
The Growing Pains of Changing Times for Acne and Rosacea Pathophysiology: Where Will It All End Up?
It is interesting to observe the changes in dermatology that have occurred over the last 1 to 2 decades, especially as major advances in basic science research techniques have rapidly expanded our current understanding of the pathophysiology of many disease states—psoriasis, psoriatic arthritis, atopic dermatitis, alopecia areata, vitiligo, hidradenitis suppurativa, and lichen planus.1 Although acne vulgaris (AV) and rosacea do not make front-page news quite as often as some of these other aforementioned disease states in the pathophysiology arena, advances still have been made in understanding the pathophysiology, albeit slower and often less popularized in dermatology publications and other forms of media.2-4
If one looks at our fundamental understanding of AV, most of the discussion over multiple decades has been driven by new treatments and in some cases new formulations and packaging differences with topical agents. Although we understood that adrenarche, a subsequent increase in androgen synthesis, and the ensuing sebocyte development with formation of sebum were prerequisites for the development of AV, the absence of therapeutic options to address these vital components of AV—especially US Food and Drug Administration (FDA)–approved therapies—resulted in limited discussion about this specific area.5 Rather, the discussion was dominated by the notable role of Propionibacterium acnes (now called Cutibacterium acnes) in AV pathophysiology, as we had therapies such as benzoyl peroxide and antibiotics that improved AV in direct correlation with reductions in P acnes.6 This was soon coupled with an advanced understanding of how to reduce follicular hyperkeratinization with the development of topical tretinoin, followed by 3 other topical retinoids over time—adapalene, tazarotene, and trifarotene. Over subsequent years, slowly emerging basic science developments and collective data reviews added to our understanding of AV and how different therapies appear to work, including the role of toll-like receptors, anti-inflammatory properties of tetracyclines, and inflammasomes.7-9 Without a doubt, the availability of oral isotretinoin revolutionized AV therapy, especially in patients with severe refractory disease, with advanced formulations allowing for optimization of sustained remission without the need for high dietary fat intake.10-12
Progress in the pathophysiology of rosacea has been slower to develop, with the first true discussion of specific clinical presentations published after the new millennium.13 This was followed by more advanced basic science and clinical research, which led to an improved ability to understand modes of action of various therapies and to correlate treatment selection with specific visible manifestations of rosacea, including incorporation of physical devices.14-16 A newer perspective on evaluation and management of rosacea moved away from the “buckets” of rosacea subtypes to phenotypes observed at the time of clinical presentation.17,18
I could elaborate on research advancements with both diseases, but the bottom line is that information, developments, and current perspectives change over time. Keeping up is a challenge for all who study and practice dermatology. It is human nature to revert to what we already believe and do, which sometimes remains valid and other times is quite outdated and truly replaced by more optimal approaches. With AV and rosacea, progress is much slower in availability of newer agents. With AV, new agents have included topical dapsone, oral sarecycline, and topical clascoterone, with the latter being the first FDA-approved topical agent to mitigate the effects of androgens and sebum in both males and females. For rosacea, the 2 most recent FDA-approved therapies are minocycline foam and microencapsulated benzoyl peroxide. All of these therapies are proven to be effective for the modes of action and skin manifestations they specifically manage. Over the upcoming year, we are hoping to see the first triple-combination topical product come to market for AV, which will prompt our minds to consider if and how 3 established agents can work together to further augment treatment efficacy with favorable tolerability and safety.
Where will all of this end up? It is hard to say. We still have several other areas to tackle with both disease states, including establishing a well-substantiated understanding of the pathophysiologic role of the microbiome, sorting out the role of antibiotic use due to concerns about bacterial resistance, integration of FDA-approved physical devices in AV, and data on both diet and optimized skin care, to name a few.19-21
There is a lot on the plate to accomplish and digest. I have remained very involved in this subject matter for almost 3 decades and am still feeling the growing pains. Fortunately, the satisfaction of being part of a process so important to the lives of millions of patients makes this worth every moment. Stay tuned—more valuable information is to come.
- Wu J, Fang Z, Liu T, et al. Maximizing the utility of transcriptomics data in inflammatory skin diseases. Front Immunol. 2021;12:761890.
- Firlej E, Kowalska W, Szymaszek K, et al. The role of skin immune system in acne. J Clin Med. 2022;11:1579.
- Mias C, Mengeaud V, Bessou-Touya S, et al. Recent advances in understanding inflammatory acne: deciphering the relationship between Cutibacterium acnes and Th17 inflammatory pathway. J Eur Acad Dermatol Venereol. 2023;(37 suppl 2):3-11.
- Buddenkotte J, Steinhoff M. Recent advances in understanding and managing rosacea. F1000Res. 2018;7:F1000 Faculty Rev-1885. doi:10.12688/f1000research.16537.1
- Platsidaki E, Dessinioti C. Recent advances in understanding Propionibacterium acnes (Cutibacterium acnes) in acne. F1000Res. 2018;7:F1000 Faculty Rev-1953. doi:10.12688/f1000research.15659.1
- Leyden JJ. The evolving role of Propionibacterium acnes in acne. Semin Cutan Med Surg. 2001;20:139-143.
- Kim J. Review of the innate immune response in acne vulgaris: activation of toll-like receptor 2 in acne triggers inflammatory cytokine responses. Dermatology. 2005;211:193-198.
- Del Rosso JQ, Webster G, Weiss JS, et al. Nonantibiotic properties of tetracyclines in rosacea and their clinical implications. J Clin Aesthet Dermatol. 2021;14:14-21.
- Zhu W, Wang HL, Bu XL, et al. A narrative review of research progress on the role of NLRP3 inflammasome in acne vulgaris. Ann Transl Med. 2022;10:645.
- Leyden JJ, Del Rosso JQ, Baum EW. The use of isotretinoin in the treatment of acne vulgaris: clinical considerations and future directions. J Clin Aesthet Dermatol. 2014;7(2 suppl):S3-S21.
- Webster GF, Leyden JJ, Gross JA. Comparative pharmacokinetic profiles of a novel isotretinoin formulation (isotretinoin-Lidose) and the innovator isotretinoin formulation: a randomized, treatment, crossover study. J Am Acad Dermatol. 2013;69:762-767.
- Del Rosso JQ, Stein Gold L, Seagal J, et al. An open-label, phase IV study evaluating Lidose-isotretinoin administered without food in patients with severe recalcitrant nodular acne: low relapse rates observed over the 104-week post-treatment period. J Clin Aesthet Dermatol. 2019;12:13-18.
- Wilkin J, Dahl M, Detmar M, et al. Standard classification of rosacea: report of the National Rosacea Society Expert Committee on the classification and staging of rosacea. J Am Acad Dermatol. 2002;46:584-587.
- Steinhoff M, Buddenkotte J, Aubert J, et al. Clinical, cellular, and molecular aspects in the pathophysiology of rosacea. J Investig Dermatol Symp Proc. 2011;15:2-11.
- Yamasaki K, Gallo RL. The molecular pathology of rosacea. J Dermatol Sci. 2009;55:77-81.
- Tanghetti E, Del Rosso JQ, Thiboutot D, et al. Consensus recommendations from the American Acne & Rosacea Society on the management of rosacea, part 4: a status report on physical modalities and devices. Cutis. 2014;93:71-76.
- Del Rosso JQ, Gallo RL, Tanghetti E, et al. An evaluation of potential correlations between pathophysiologic mechanisms, clinical manifestations, and management of rosacea. Cutis. 2013;91(3 suppl):1-8.
- Schaller M, Almeida LMC, Bewley A, et al. Recommendations for rosacea diagnosis, classification and management: update from the global ROSacea COnsensus 2019 panel. Br J Dermatol. 2020;182:1269-1276.
- Xu H, Li H. Acne, the skin microbiome, and antibiotic treatment. Am J Clin Dermatol. 2019;20:335-344.
- Daou H, Paradiso M, Hennessy K. Rosacea and the microbiome: a systematic review. Dermatol Ther (Heidelb). 2021;11:1-12.
- Kayiran MA, Karadag AS, Al-Khuzaei S, et al. Antibiotic resistance in acne: mechanisms, complications and management. Am J Clin Dermatol. 2020;21:813-819.
It is interesting to observe the changes in dermatology that have occurred over the last 1 to 2 decades, especially as major advances in basic science research techniques have rapidly expanded our current understanding of the pathophysiology of many disease states—psoriasis, psoriatic arthritis, atopic dermatitis, alopecia areata, vitiligo, hidradenitis suppurativa, and lichen planus.1 Although acne vulgaris (AV) and rosacea do not make front-page news quite as often as some of these other aforementioned disease states in the pathophysiology arena, advances still have been made in understanding the pathophysiology, albeit slower and often less popularized in dermatology publications and other forms of media.2-4
If one looks at our fundamental understanding of AV, most of the discussion over multiple decades has been driven by new treatments and in some cases new formulations and packaging differences with topical agents. Although we understood that adrenarche, a subsequent increase in androgen synthesis, and the ensuing sebocyte development with formation of sebum were prerequisites for the development of AV, the absence of therapeutic options to address these vital components of AV—especially US Food and Drug Administration (FDA)–approved therapies—resulted in limited discussion about this specific area.5 Rather, the discussion was dominated by the notable role of Propionibacterium acnes (now called Cutibacterium acnes) in AV pathophysiology, as we had therapies such as benzoyl peroxide and antibiotics that improved AV in direct correlation with reductions in P acnes.6 This was soon coupled with an advanced understanding of how to reduce follicular hyperkeratinization with the development of topical tretinoin, followed by 3 other topical retinoids over time—adapalene, tazarotene, and trifarotene. Over subsequent years, slowly emerging basic science developments and collective data reviews added to our understanding of AV and how different therapies appear to work, including the role of toll-like receptors, anti-inflammatory properties of tetracyclines, and inflammasomes.7-9 Without a doubt, the availability of oral isotretinoin revolutionized AV therapy, especially in patients with severe refractory disease, with advanced formulations allowing for optimization of sustained remission without the need for high dietary fat intake.10-12
Progress in the pathophysiology of rosacea has been slower to develop, with the first true discussion of specific clinical presentations published after the new millennium.13 This was followed by more advanced basic science and clinical research, which led to an improved ability to understand modes of action of various therapies and to correlate treatment selection with specific visible manifestations of rosacea, including incorporation of physical devices.14-16 A newer perspective on evaluation and management of rosacea moved away from the “buckets” of rosacea subtypes to phenotypes observed at the time of clinical presentation.17,18
I could elaborate on research advancements with both diseases, but the bottom line is that information, developments, and current perspectives change over time. Keeping up is a challenge for all who study and practice dermatology. It is human nature to revert to what we already believe and do, which sometimes remains valid and other times is quite outdated and truly replaced by more optimal approaches. With AV and rosacea, progress is much slower in availability of newer agents. With AV, new agents have included topical dapsone, oral sarecycline, and topical clascoterone, with the latter being the first FDA-approved topical agent to mitigate the effects of androgens and sebum in both males and females. For rosacea, the 2 most recent FDA-approved therapies are minocycline foam and microencapsulated benzoyl peroxide. All of these therapies are proven to be effective for the modes of action and skin manifestations they specifically manage. Over the upcoming year, we are hoping to see the first triple-combination topical product come to market for AV, which will prompt our minds to consider if and how 3 established agents can work together to further augment treatment efficacy with favorable tolerability and safety.
Where will all of this end up? It is hard to say. We still have several other areas to tackle with both disease states, including establishing a well-substantiated understanding of the pathophysiologic role of the microbiome, sorting out the role of antibiotic use due to concerns about bacterial resistance, integration of FDA-approved physical devices in AV, and data on both diet and optimized skin care, to name a few.19-21
There is a lot on the plate to accomplish and digest. I have remained very involved in this subject matter for almost 3 decades and am still feeling the growing pains. Fortunately, the satisfaction of being part of a process so important to the lives of millions of patients makes this worth every moment. Stay tuned—more valuable information is to come.
It is interesting to observe the changes in dermatology that have occurred over the last 1 to 2 decades, especially as major advances in basic science research techniques have rapidly expanded our current understanding of the pathophysiology of many disease states—psoriasis, psoriatic arthritis, atopic dermatitis, alopecia areata, vitiligo, hidradenitis suppurativa, and lichen planus.1 Although acne vulgaris (AV) and rosacea do not make front-page news quite as often as some of these other aforementioned disease states in the pathophysiology arena, advances still have been made in understanding the pathophysiology, albeit slower and often less popularized in dermatology publications and other forms of media.2-4
If one looks at our fundamental understanding of AV, most of the discussion over multiple decades has been driven by new treatments and in some cases new formulations and packaging differences with topical agents. Although we understood that adrenarche, a subsequent increase in androgen synthesis, and the ensuing sebocyte development with formation of sebum were prerequisites for the development of AV, the absence of therapeutic options to address these vital components of AV—especially US Food and Drug Administration (FDA)–approved therapies—resulted in limited discussion about this specific area.5 Rather, the discussion was dominated by the notable role of Propionibacterium acnes (now called Cutibacterium acnes) in AV pathophysiology, as we had therapies such as benzoyl peroxide and antibiotics that improved AV in direct correlation with reductions in P acnes.6 This was soon coupled with an advanced understanding of how to reduce follicular hyperkeratinization with the development of topical tretinoin, followed by 3 other topical retinoids over time—adapalene, tazarotene, and trifarotene. Over subsequent years, slowly emerging basic science developments and collective data reviews added to our understanding of AV and how different therapies appear to work, including the role of toll-like receptors, anti-inflammatory properties of tetracyclines, and inflammasomes.7-9 Without a doubt, the availability of oral isotretinoin revolutionized AV therapy, especially in patients with severe refractory disease, with advanced formulations allowing for optimization of sustained remission without the need for high dietary fat intake.10-12
Progress in the pathophysiology of rosacea has been slower to develop, with the first true discussion of specific clinical presentations published after the new millennium.13 This was followed by more advanced basic science and clinical research, which led to an improved ability to understand modes of action of various therapies and to correlate treatment selection with specific visible manifestations of rosacea, including incorporation of physical devices.14-16 A newer perspective on evaluation and management of rosacea moved away from the “buckets” of rosacea subtypes to phenotypes observed at the time of clinical presentation.17,18
I could elaborate on research advancements with both diseases, but the bottom line is that information, developments, and current perspectives change over time. Keeping up is a challenge for all who study and practice dermatology. It is human nature to revert to what we already believe and do, which sometimes remains valid and other times is quite outdated and truly replaced by more optimal approaches. With AV and rosacea, progress is much slower in availability of newer agents. With AV, new agents have included topical dapsone, oral sarecycline, and topical clascoterone, with the latter being the first FDA-approved topical agent to mitigate the effects of androgens and sebum in both males and females. For rosacea, the 2 most recent FDA-approved therapies are minocycline foam and microencapsulated benzoyl peroxide. All of these therapies are proven to be effective for the modes of action and skin manifestations they specifically manage. Over the upcoming year, we are hoping to see the first triple-combination topical product come to market for AV, which will prompt our minds to consider if and how 3 established agents can work together to further augment treatment efficacy with favorable tolerability and safety.
Where will all of this end up? It is hard to say. We still have several other areas to tackle with both disease states, including establishing a well-substantiated understanding of the pathophysiologic role of the microbiome, sorting out the role of antibiotic use due to concerns about bacterial resistance, integration of FDA-approved physical devices in AV, and data on both diet and optimized skin care, to name a few.19-21
There is a lot on the plate to accomplish and digest. I have remained very involved in this subject matter for almost 3 decades and am still feeling the growing pains. Fortunately, the satisfaction of being part of a process so important to the lives of millions of patients makes this worth every moment. Stay tuned—more valuable information is to come.
- Wu J, Fang Z, Liu T, et al. Maximizing the utility of transcriptomics data in inflammatory skin diseases. Front Immunol. 2021;12:761890.
- Firlej E, Kowalska W, Szymaszek K, et al. The role of skin immune system in acne. J Clin Med. 2022;11:1579.
- Mias C, Mengeaud V, Bessou-Touya S, et al. Recent advances in understanding inflammatory acne: deciphering the relationship between Cutibacterium acnes and Th17 inflammatory pathway. J Eur Acad Dermatol Venereol. 2023;(37 suppl 2):3-11.
- Buddenkotte J, Steinhoff M. Recent advances in understanding and managing rosacea. F1000Res. 2018;7:F1000 Faculty Rev-1885. doi:10.12688/f1000research.16537.1
- Platsidaki E, Dessinioti C. Recent advances in understanding Propionibacterium acnes (Cutibacterium acnes) in acne. F1000Res. 2018;7:F1000 Faculty Rev-1953. doi:10.12688/f1000research.15659.1
- Leyden JJ. The evolving role of Propionibacterium acnes in acne. Semin Cutan Med Surg. 2001;20:139-143.
- Kim J. Review of the innate immune response in acne vulgaris: activation of toll-like receptor 2 in acne triggers inflammatory cytokine responses. Dermatology. 2005;211:193-198.
- Del Rosso JQ, Webster G, Weiss JS, et al. Nonantibiotic properties of tetracyclines in rosacea and their clinical implications. J Clin Aesthet Dermatol. 2021;14:14-21.
- Zhu W, Wang HL, Bu XL, et al. A narrative review of research progress on the role of NLRP3 inflammasome in acne vulgaris. Ann Transl Med. 2022;10:645.
- Leyden JJ, Del Rosso JQ, Baum EW. The use of isotretinoin in the treatment of acne vulgaris: clinical considerations and future directions. J Clin Aesthet Dermatol. 2014;7(2 suppl):S3-S21.
- Webster GF, Leyden JJ, Gross JA. Comparative pharmacokinetic profiles of a novel isotretinoin formulation (isotretinoin-Lidose) and the innovator isotretinoin formulation: a randomized, treatment, crossover study. J Am Acad Dermatol. 2013;69:762-767.
- Del Rosso JQ, Stein Gold L, Seagal J, et al. An open-label, phase IV study evaluating Lidose-isotretinoin administered without food in patients with severe recalcitrant nodular acne: low relapse rates observed over the 104-week post-treatment period. J Clin Aesthet Dermatol. 2019;12:13-18.
- Wilkin J, Dahl M, Detmar M, et al. Standard classification of rosacea: report of the National Rosacea Society Expert Committee on the classification and staging of rosacea. J Am Acad Dermatol. 2002;46:584-587.
- Steinhoff M, Buddenkotte J, Aubert J, et al. Clinical, cellular, and molecular aspects in the pathophysiology of rosacea. J Investig Dermatol Symp Proc. 2011;15:2-11.
- Yamasaki K, Gallo RL. The molecular pathology of rosacea. J Dermatol Sci. 2009;55:77-81.
- Tanghetti E, Del Rosso JQ, Thiboutot D, et al. Consensus recommendations from the American Acne & Rosacea Society on the management of rosacea, part 4: a status report on physical modalities and devices. Cutis. 2014;93:71-76.
- Del Rosso JQ, Gallo RL, Tanghetti E, et al. An evaluation of potential correlations between pathophysiologic mechanisms, clinical manifestations, and management of rosacea. Cutis. 2013;91(3 suppl):1-8.
- Schaller M, Almeida LMC, Bewley A, et al. Recommendations for rosacea diagnosis, classification and management: update from the global ROSacea COnsensus 2019 panel. Br J Dermatol. 2020;182:1269-1276.
- Xu H, Li H. Acne, the skin microbiome, and antibiotic treatment. Am J Clin Dermatol. 2019;20:335-344.
- Daou H, Paradiso M, Hennessy K. Rosacea and the microbiome: a systematic review. Dermatol Ther (Heidelb). 2021;11:1-12.
- Kayiran MA, Karadag AS, Al-Khuzaei S, et al. Antibiotic resistance in acne: mechanisms, complications and management. Am J Clin Dermatol. 2020;21:813-819.
- Wu J, Fang Z, Liu T, et al. Maximizing the utility of transcriptomics data in inflammatory skin diseases. Front Immunol. 2021;12:761890.
- Firlej E, Kowalska W, Szymaszek K, et al. The role of skin immune system in acne. J Clin Med. 2022;11:1579.
- Mias C, Mengeaud V, Bessou-Touya S, et al. Recent advances in understanding inflammatory acne: deciphering the relationship between Cutibacterium acnes and Th17 inflammatory pathway. J Eur Acad Dermatol Venereol. 2023;(37 suppl 2):3-11.
- Buddenkotte J, Steinhoff M. Recent advances in understanding and managing rosacea. F1000Res. 2018;7:F1000 Faculty Rev-1885. doi:10.12688/f1000research.16537.1
- Platsidaki E, Dessinioti C. Recent advances in understanding Propionibacterium acnes (Cutibacterium acnes) in acne. F1000Res. 2018;7:F1000 Faculty Rev-1953. doi:10.12688/f1000research.15659.1
- Leyden JJ. The evolving role of Propionibacterium acnes in acne. Semin Cutan Med Surg. 2001;20:139-143.
- Kim J. Review of the innate immune response in acne vulgaris: activation of toll-like receptor 2 in acne triggers inflammatory cytokine responses. Dermatology. 2005;211:193-198.
- Del Rosso JQ, Webster G, Weiss JS, et al. Nonantibiotic properties of tetracyclines in rosacea and their clinical implications. J Clin Aesthet Dermatol. 2021;14:14-21.
- Zhu W, Wang HL, Bu XL, et al. A narrative review of research progress on the role of NLRP3 inflammasome in acne vulgaris. Ann Transl Med. 2022;10:645.
- Leyden JJ, Del Rosso JQ, Baum EW. The use of isotretinoin in the treatment of acne vulgaris: clinical considerations and future directions. J Clin Aesthet Dermatol. 2014;7(2 suppl):S3-S21.
- Webster GF, Leyden JJ, Gross JA. Comparative pharmacokinetic profiles of a novel isotretinoin formulation (isotretinoin-Lidose) and the innovator isotretinoin formulation: a randomized, treatment, crossover study. J Am Acad Dermatol. 2013;69:762-767.
- Del Rosso JQ, Stein Gold L, Seagal J, et al. An open-label, phase IV study evaluating Lidose-isotretinoin administered without food in patients with severe recalcitrant nodular acne: low relapse rates observed over the 104-week post-treatment period. J Clin Aesthet Dermatol. 2019;12:13-18.
- Wilkin J, Dahl M, Detmar M, et al. Standard classification of rosacea: report of the National Rosacea Society Expert Committee on the classification and staging of rosacea. J Am Acad Dermatol. 2002;46:584-587.
- Steinhoff M, Buddenkotte J, Aubert J, et al. Clinical, cellular, and molecular aspects in the pathophysiology of rosacea. J Investig Dermatol Symp Proc. 2011;15:2-11.
- Yamasaki K, Gallo RL. The molecular pathology of rosacea. J Dermatol Sci. 2009;55:77-81.
- Tanghetti E, Del Rosso JQ, Thiboutot D, et al. Consensus recommendations from the American Acne & Rosacea Society on the management of rosacea, part 4: a status report on physical modalities and devices. Cutis. 2014;93:71-76.
- Del Rosso JQ, Gallo RL, Tanghetti E, et al. An evaluation of potential correlations between pathophysiologic mechanisms, clinical manifestations, and management of rosacea. Cutis. 2013;91(3 suppl):1-8.
- Schaller M, Almeida LMC, Bewley A, et al. Recommendations for rosacea diagnosis, classification and management: update from the global ROSacea COnsensus 2019 panel. Br J Dermatol. 2020;182:1269-1276.
- Xu H, Li H. Acne, the skin microbiome, and antibiotic treatment. Am J Clin Dermatol. 2019;20:335-344.
- Daou H, Paradiso M, Hennessy K. Rosacea and the microbiome: a systematic review. Dermatol Ther (Heidelb). 2021;11:1-12.
- Kayiran MA, Karadag AS, Al-Khuzaei S, et al. Antibiotic resistance in acne: mechanisms, complications and management. Am J Clin Dermatol. 2020;21:813-819.
Treating rosacea: Combination therapy, benzoyl peroxide, and the ‘STOP’ mnemonic
HONOLULU – More often than not, patients with rosacea require a combination of treatments to optimize the management of the disease, according to Julie C. Harper, MD.
“We’ve been more comfortable with the idea of combination therapy for acne than we have been for rosacea,” Dr. Harper, who practices in Birmingham, Ala., said at the Hawaii Dermatology Seminar provided by MedscapeLIVE! “If patients are doing great on one treatment, then don’t change it. But if there’s room for improvement, think about combinations.”
Treatment options for papules and pustules include ivermectin, metronidazole, azelaic acid, sodium sulfacetamide/sulfur, modified release doxycycline, minocycline foam, and microencapsulated benzoyl peroxide, 5%. Options for persistent background erythema include brimonidine and oxymetazoline, as well as device-based treatments, which include the pulsed dye laser, the KTP laser, intense pulsed light, and electrosurgery.
Dr. Harper said that she has been especially surprised by the effectiveness of one of these options, microencapsulated benzoyl peroxide cream, 5% (Epsolay), which is approved by the Food and Drug Administration for treating inflammatory lesions of rosacea in adults. In two identical, phase 3 randomized clinical trials of patients with inflammatory rosacea lesions, those treated with microencapsulated benzoyl peroxide achieved a 68.8% reduction in inflammatory lesions at 12 weeks (including 42.5% at week 2), compared with 38%-46% of those on the vehicle, according to the April 2022 announcement of the approval from the manufacturers, Sol-Gel Technologies and Galderma.
“A common drug is playing a key role,” Dr. Harper said. “What’s the mechanism of action? I have no idea. I wonder if there may be a bacterial pathogen after all,” possibly Staphylococcus epidermidis, she added. However, she noted, “it does appear that benzoyl peroxide has an impact on Demodex, so maybe that’s the primary way it’s working.”
In her opinion, a key standout from the clinical trial data is the drug’s rapid onset of action, with a 42.5% reduction of lesions at week 2. “What makes this different is that the 5% microencapsulated benzoyl peroxide cream is wrapped up in a silica shell,” said Dr. Harper, a past president of the American Acne and Rosacea Society. “The silica shell kind of acts like a speed bump that slows the release of drug onto the skin. We think that’s what may be giving us this better tolerability.”
In an interview at the meeting, Linda Stein Gold, MD, director of clinical research and division head of dermatology at the Henry Ford Health System, Detroit, said that prior to the approval of Epsolay, benzoyl peroxide was never considered a first-line treatment for rosacea. “The problem is, the conventional formulation is irritating to the skin,” said Dr. Stein Gold, who was involved in clinical trials of Epsolay.
“The benzoyl peroxide encapsulated in the silica shell allows for a slow and steady delivery of medication to the skin in a very controlled manner. It is exceptionally good at getting rosacea under control. In the clinical trials, when we looked at the baseline irritation of the skin and followed those patients when they used the benzoyl 5% microencapsulated benzoyl peroxide cream, the irritation improved.”
‘STOP’ mnemonic
When treating her patients with rosacea, Dr. Harper incorporates the mnemonic “STOP” to these patient visits:
S: Identify signs and symptoms of rosacea.
T: Discuss triggers. “We cannot make this disease triggerless, so when you’re talking to your patients, you need to find out what’s triggering their rosacea,” she said.
O: Agree on a treatment outcome. “What is it that’s important to the patient?” she said. “They may tell you, ‘I want to be able to not be so red,’ or ‘I want to get rid of the bumps,’ or ‘I want my eyes to not feel so dry.’ ”
P: Develop a plan that helps achieve that desired outcome with patients.
Dr. Harper disclosed ties with Almirall, Cassiopeia, Cutera, Galderma, EPI, L’Oréal, Ortho Dermatologics, Sol Gel, Sun Pharmaceutical Industries, and Vyne.
Dr. Stein Gold disclosed ties with Almirall, Cutera, Dermata, Galderma, Novartis, Ortho Dermatologics, and Sun Pharmaceutical Industries.
Medscape and this news organization are owned by the same parent company.
HONOLULU – More often than not, patients with rosacea require a combination of treatments to optimize the management of the disease, according to Julie C. Harper, MD.
“We’ve been more comfortable with the idea of combination therapy for acne than we have been for rosacea,” Dr. Harper, who practices in Birmingham, Ala., said at the Hawaii Dermatology Seminar provided by MedscapeLIVE! “If patients are doing great on one treatment, then don’t change it. But if there’s room for improvement, think about combinations.”
Treatment options for papules and pustules include ivermectin, metronidazole, azelaic acid, sodium sulfacetamide/sulfur, modified release doxycycline, minocycline foam, and microencapsulated benzoyl peroxide, 5%. Options for persistent background erythema include brimonidine and oxymetazoline, as well as device-based treatments, which include the pulsed dye laser, the KTP laser, intense pulsed light, and electrosurgery.
Dr. Harper said that she has been especially surprised by the effectiveness of one of these options, microencapsulated benzoyl peroxide cream, 5% (Epsolay), which is approved by the Food and Drug Administration for treating inflammatory lesions of rosacea in adults. In two identical, phase 3 randomized clinical trials of patients with inflammatory rosacea lesions, those treated with microencapsulated benzoyl peroxide achieved a 68.8% reduction in inflammatory lesions at 12 weeks (including 42.5% at week 2), compared with 38%-46% of those on the vehicle, according to the April 2022 announcement of the approval from the manufacturers, Sol-Gel Technologies and Galderma.
“A common drug is playing a key role,” Dr. Harper said. “What’s the mechanism of action? I have no idea. I wonder if there may be a bacterial pathogen after all,” possibly Staphylococcus epidermidis, she added. However, she noted, “it does appear that benzoyl peroxide has an impact on Demodex, so maybe that’s the primary way it’s working.”
In her opinion, a key standout from the clinical trial data is the drug’s rapid onset of action, with a 42.5% reduction of lesions at week 2. “What makes this different is that the 5% microencapsulated benzoyl peroxide cream is wrapped up in a silica shell,” said Dr. Harper, a past president of the American Acne and Rosacea Society. “The silica shell kind of acts like a speed bump that slows the release of drug onto the skin. We think that’s what may be giving us this better tolerability.”
In an interview at the meeting, Linda Stein Gold, MD, director of clinical research and division head of dermatology at the Henry Ford Health System, Detroit, said that prior to the approval of Epsolay, benzoyl peroxide was never considered a first-line treatment for rosacea. “The problem is, the conventional formulation is irritating to the skin,” said Dr. Stein Gold, who was involved in clinical trials of Epsolay.
“The benzoyl peroxide encapsulated in the silica shell allows for a slow and steady delivery of medication to the skin in a very controlled manner. It is exceptionally good at getting rosacea under control. In the clinical trials, when we looked at the baseline irritation of the skin and followed those patients when they used the benzoyl 5% microencapsulated benzoyl peroxide cream, the irritation improved.”
‘STOP’ mnemonic
When treating her patients with rosacea, Dr. Harper incorporates the mnemonic “STOP” to these patient visits:
S: Identify signs and symptoms of rosacea.
T: Discuss triggers. “We cannot make this disease triggerless, so when you’re talking to your patients, you need to find out what’s triggering their rosacea,” she said.
O: Agree on a treatment outcome. “What is it that’s important to the patient?” she said. “They may tell you, ‘I want to be able to not be so red,’ or ‘I want to get rid of the bumps,’ or ‘I want my eyes to not feel so dry.’ ”
P: Develop a plan that helps achieve that desired outcome with patients.
Dr. Harper disclosed ties with Almirall, Cassiopeia, Cutera, Galderma, EPI, L’Oréal, Ortho Dermatologics, Sol Gel, Sun Pharmaceutical Industries, and Vyne.
Dr. Stein Gold disclosed ties with Almirall, Cutera, Dermata, Galderma, Novartis, Ortho Dermatologics, and Sun Pharmaceutical Industries.
Medscape and this news organization are owned by the same parent company.
HONOLULU – More often than not, patients with rosacea require a combination of treatments to optimize the management of the disease, according to Julie C. Harper, MD.
“We’ve been more comfortable with the idea of combination therapy for acne than we have been for rosacea,” Dr. Harper, who practices in Birmingham, Ala., said at the Hawaii Dermatology Seminar provided by MedscapeLIVE! “If patients are doing great on one treatment, then don’t change it. But if there’s room for improvement, think about combinations.”
Treatment options for papules and pustules include ivermectin, metronidazole, azelaic acid, sodium sulfacetamide/sulfur, modified release doxycycline, minocycline foam, and microencapsulated benzoyl peroxide, 5%. Options for persistent background erythema include brimonidine and oxymetazoline, as well as device-based treatments, which include the pulsed dye laser, the KTP laser, intense pulsed light, and electrosurgery.
Dr. Harper said that she has been especially surprised by the effectiveness of one of these options, microencapsulated benzoyl peroxide cream, 5% (Epsolay), which is approved by the Food and Drug Administration for treating inflammatory lesions of rosacea in adults. In two identical, phase 3 randomized clinical trials of patients with inflammatory rosacea lesions, those treated with microencapsulated benzoyl peroxide achieved a 68.8% reduction in inflammatory lesions at 12 weeks (including 42.5% at week 2), compared with 38%-46% of those on the vehicle, according to the April 2022 announcement of the approval from the manufacturers, Sol-Gel Technologies and Galderma.
“A common drug is playing a key role,” Dr. Harper said. “What’s the mechanism of action? I have no idea. I wonder if there may be a bacterial pathogen after all,” possibly Staphylococcus epidermidis, she added. However, she noted, “it does appear that benzoyl peroxide has an impact on Demodex, so maybe that’s the primary way it’s working.”
In her opinion, a key standout from the clinical trial data is the drug’s rapid onset of action, with a 42.5% reduction of lesions at week 2. “What makes this different is that the 5% microencapsulated benzoyl peroxide cream is wrapped up in a silica shell,” said Dr. Harper, a past president of the American Acne and Rosacea Society. “The silica shell kind of acts like a speed bump that slows the release of drug onto the skin. We think that’s what may be giving us this better tolerability.”
In an interview at the meeting, Linda Stein Gold, MD, director of clinical research and division head of dermatology at the Henry Ford Health System, Detroit, said that prior to the approval of Epsolay, benzoyl peroxide was never considered a first-line treatment for rosacea. “The problem is, the conventional formulation is irritating to the skin,” said Dr. Stein Gold, who was involved in clinical trials of Epsolay.
“The benzoyl peroxide encapsulated in the silica shell allows for a slow and steady delivery of medication to the skin in a very controlled manner. It is exceptionally good at getting rosacea under control. In the clinical trials, when we looked at the baseline irritation of the skin and followed those patients when they used the benzoyl 5% microencapsulated benzoyl peroxide cream, the irritation improved.”
‘STOP’ mnemonic
When treating her patients with rosacea, Dr. Harper incorporates the mnemonic “STOP” to these patient visits:
S: Identify signs and symptoms of rosacea.
T: Discuss triggers. “We cannot make this disease triggerless, so when you’re talking to your patients, you need to find out what’s triggering their rosacea,” she said.
O: Agree on a treatment outcome. “What is it that’s important to the patient?” she said. “They may tell you, ‘I want to be able to not be so red,’ or ‘I want to get rid of the bumps,’ or ‘I want my eyes to not feel so dry.’ ”
P: Develop a plan that helps achieve that desired outcome with patients.
Dr. Harper disclosed ties with Almirall, Cassiopeia, Cutera, Galderma, EPI, L’Oréal, Ortho Dermatologics, Sol Gel, Sun Pharmaceutical Industries, and Vyne.
Dr. Stein Gold disclosed ties with Almirall, Cutera, Dermata, Galderma, Novartis, Ortho Dermatologics, and Sun Pharmaceutical Industries.
Medscape and this news organization are owned by the same parent company.
AT THE MEDSCAPE LIVE! HAWAII DERMATOLOGY SEMINAR
NRS grants target rosacea’s underlying mechanisms
Two new
, according to an announcement by the NRS.As part of the NRS research grants program, the organization recently awarded $10,000 to Emanual Maverakis, MD, professor of dermatology, University of California, Davis, and research fellow Samantha Herbert, MSPH. Their project will characterize rosacea pathophysiology using single-cell RNA sequencing. This novel analytical technique provides specific information on the signals expressed by different cell types and will help researchers better understand the role each subtype may play in rosacea, along with how these cells interact with each other, according to the NRS press release. New knowledge in the foregoing areas may fuel development of better therapies, the release added.
The NRS awarded its second new-research grant to Arisa Ortiz, MD, director of laser and cosmetic dermatology and associate professor of dermatology, University of California, San Diego. She was awarded $5,000 to examine whether laser therapy affects the skin microbiome, the complex ecosystem of bacteria and other microorganisms that reside on the skin. Studies have detected significant differences – such as higher levels of Demodex folliculorum and Staphylococcus epidermidis and lower levels of Cutibacterium acnes – in the microbiome of skin with rosacea compared with healthy skin. Dr. Ortiz’s research also will probe how blood vessels, which laser therapy often target, contribute to the rosacea disease process.
The NRS also renewed its support of an ongoing study led by Sezen Karakus, MD, assistant professor of ophthalmology at the Johns Hopkins Wilmer Eye Institute, Baltimore. She is studying the role of the ocular-surface microbiome in rosacea pathogenesis. Because ocular rosacea can lead to vision-threatening corneal complications, Dr. Karakus said in the press release, identifying microorganisms present on the ocular surface may spur development of targeted treatment strategies.
A second ongoing study for which the NRS renewed funding is investigating whether certain intracellular signals recently found to be elevated in rosacea lesions may drive skin inflammation, which may be a root cause of rosacea. Emmanuel Contassot, PhD, project leader in the dermatology department at the University Hospital of Basel, Switzerland, is leading the study.
To date, the NRS research grants program has awarded more than $1.6 million to research designed to further elucidate potential causes and other key aspects of rosacea with the goal of advancing treatment, prevention, or potential cure of rosacea.
For interested researchers, the deadline to submit proposals for next year’s grants is June 16, 2023. Forms and instructions are available through the research grants section of the NRS website or by contacting the NRS at 4619 N. Ravenswood Ave., Suite 103, Chicago, IL 60640; 888-662-5874; or [email protected].
Two new
, according to an announcement by the NRS.As part of the NRS research grants program, the organization recently awarded $10,000 to Emanual Maverakis, MD, professor of dermatology, University of California, Davis, and research fellow Samantha Herbert, MSPH. Their project will characterize rosacea pathophysiology using single-cell RNA sequencing. This novel analytical technique provides specific information on the signals expressed by different cell types and will help researchers better understand the role each subtype may play in rosacea, along with how these cells interact with each other, according to the NRS press release. New knowledge in the foregoing areas may fuel development of better therapies, the release added.
The NRS awarded its second new-research grant to Arisa Ortiz, MD, director of laser and cosmetic dermatology and associate professor of dermatology, University of California, San Diego. She was awarded $5,000 to examine whether laser therapy affects the skin microbiome, the complex ecosystem of bacteria and other microorganisms that reside on the skin. Studies have detected significant differences – such as higher levels of Demodex folliculorum and Staphylococcus epidermidis and lower levels of Cutibacterium acnes – in the microbiome of skin with rosacea compared with healthy skin. Dr. Ortiz’s research also will probe how blood vessels, which laser therapy often target, contribute to the rosacea disease process.
The NRS also renewed its support of an ongoing study led by Sezen Karakus, MD, assistant professor of ophthalmology at the Johns Hopkins Wilmer Eye Institute, Baltimore. She is studying the role of the ocular-surface microbiome in rosacea pathogenesis. Because ocular rosacea can lead to vision-threatening corneal complications, Dr. Karakus said in the press release, identifying microorganisms present on the ocular surface may spur development of targeted treatment strategies.
A second ongoing study for which the NRS renewed funding is investigating whether certain intracellular signals recently found to be elevated in rosacea lesions may drive skin inflammation, which may be a root cause of rosacea. Emmanuel Contassot, PhD, project leader in the dermatology department at the University Hospital of Basel, Switzerland, is leading the study.
To date, the NRS research grants program has awarded more than $1.6 million to research designed to further elucidate potential causes and other key aspects of rosacea with the goal of advancing treatment, prevention, or potential cure of rosacea.
For interested researchers, the deadline to submit proposals for next year’s grants is June 16, 2023. Forms and instructions are available through the research grants section of the NRS website or by contacting the NRS at 4619 N. Ravenswood Ave., Suite 103, Chicago, IL 60640; 888-662-5874; or [email protected].
Two new
, according to an announcement by the NRS.As part of the NRS research grants program, the organization recently awarded $10,000 to Emanual Maverakis, MD, professor of dermatology, University of California, Davis, and research fellow Samantha Herbert, MSPH. Their project will characterize rosacea pathophysiology using single-cell RNA sequencing. This novel analytical technique provides specific information on the signals expressed by different cell types and will help researchers better understand the role each subtype may play in rosacea, along with how these cells interact with each other, according to the NRS press release. New knowledge in the foregoing areas may fuel development of better therapies, the release added.
The NRS awarded its second new-research grant to Arisa Ortiz, MD, director of laser and cosmetic dermatology and associate professor of dermatology, University of California, San Diego. She was awarded $5,000 to examine whether laser therapy affects the skin microbiome, the complex ecosystem of bacteria and other microorganisms that reside on the skin. Studies have detected significant differences – such as higher levels of Demodex folliculorum and Staphylococcus epidermidis and lower levels of Cutibacterium acnes – in the microbiome of skin with rosacea compared with healthy skin. Dr. Ortiz’s research also will probe how blood vessels, which laser therapy often target, contribute to the rosacea disease process.
The NRS also renewed its support of an ongoing study led by Sezen Karakus, MD, assistant professor of ophthalmology at the Johns Hopkins Wilmer Eye Institute, Baltimore. She is studying the role of the ocular-surface microbiome in rosacea pathogenesis. Because ocular rosacea can lead to vision-threatening corneal complications, Dr. Karakus said in the press release, identifying microorganisms present on the ocular surface may spur development of targeted treatment strategies.
A second ongoing study for which the NRS renewed funding is investigating whether certain intracellular signals recently found to be elevated in rosacea lesions may drive skin inflammation, which may be a root cause of rosacea. Emmanuel Contassot, PhD, project leader in the dermatology department at the University Hospital of Basel, Switzerland, is leading the study.
To date, the NRS research grants program has awarded more than $1.6 million to research designed to further elucidate potential causes and other key aspects of rosacea with the goal of advancing treatment, prevention, or potential cure of rosacea.
For interested researchers, the deadline to submit proposals for next year’s grants is June 16, 2023. Forms and instructions are available through the research grants section of the NRS website or by contacting the NRS at 4619 N. Ravenswood Ave., Suite 103, Chicago, IL 60640; 888-662-5874; or [email protected].
Rosacea and the gut: Looking into SIBO
, according to speakers at the annual Integrative Dermatology Symposium.
“SIBO is definitely something we test for and treat,” Raja Sivamani, MD, said in an interview after the meeting. Dr. Sivamani practices as an integrative dermatologist at the Pacific Skin Institute in Sacramento and is the director of clinical research at the institute’s research unit, Integrative Skin Science and Research. He led a panel discussion on rosacea and acne at the meeting.
Associations between SIBO and several dermatologic conditions, including systemic sclerosis, have been reported, but the strongest evidence to date involves rosacea. “There’s associative epidemiological evidence showing higher rates of SIBO among those with rosacea, and there are prospective studies” showing clearance of rosacea in patients treated for SIBO, said Dr. Sivamani, also adjunct associate professor of clinical dermatology at the University of California, Davis.
Studies are small, but are “well done and well-designed,” he said in the interview. “Do we need more studies? Absolutely. But what we have now is compelling [enough] for us to take a look at it.”
Findings of rosacea clearance
SIBO’s believed contribution to the pathophysiology of rosacea is part of the increasingly described gut microbiome-skin axis. SIBO has been recognized as a medical phenomenon for many decades and has been defined as an excessive bacterial load in the small bowel that causes gastrointestinal symptoms, according to the 2020 American College of Gastroenterology clinical guideline on SIBO.
Symptoms commonly associated with SIBO overlap with the cardinal symptoms of irritable bowel syndrome (IBS): abdominal pain; diarrhea, constipation, or both; bloating; and flatulence. SIBO can be diagnosed with several validated carbohydrate substrate (glucose or lactulose)–based breath tests that measure hydrogen and/or methane.
Hydrogen-positive breath tests suggest bacterial overgrowth, and methane-positive breath tests suggest small intestinal methanogen overgrowth. Methane is increasingly important and recognized, the AGA guideline says, though it creates a “nomenclature problem in the SIBO framework” because methanogens are not bacteria, the authors note.
In conventional practice, SIBO is typically treated with antibiotics such as rifaximin, and often with short-term dietary modification as well. Integrative medicine typically considers the use of supplements and botanicals in addition to or instead of antibiotics, as well as dietary change and increasingly, a close look at SIBO risk factors to prevent recurrence, Dr. Sivamani said. (His research unit is currently studying the use of herbal protocols as an alternative to antibiotics in patients with SIBO and dermatologic conditions.)
During a presentation on rosacea at the meeting, Neal Bhatia, MD, director of clinical dermatology at Therapeutics Clinical Research, a dermatology treatment and research center in San Diego, said that currently available breath tests for SIBO “are very interesting tools for understanding what may be happening in the gut” and that the “rifaximin data are good.”
He referred to a study reported in the Journal of the American Academy of Dermatology showing that patients with rosacea were significantly more likely to have SIBO (41.7% of 48 patients vs. 5.0% of 40 controls; P < .001), and that 64.5% of rosacea patients who completed treatment with rifaximin had remission of rosacea at a 3-year follow-up.
An earlier crossover study is also notable, he said. This study enrolled 113 consecutive patients with rosacea and 60 age- and sex-matched controls, and randomized those with SIBO (52 of the 113 with rosacea vs. 3 of the 60 controls) to rifaximin or placebo. Rosacea cleared in 20 of the 28 patients in the rifaximin group and greatly improved in 6 of the 28. Of 20 patients in the placebo group, rosacea remained unchanged in 18 and worsened in 2. When patients in the placebo group were switched to rifaximin, SIBO was eradicated in 17 of the 20, and rosacea completely resolved in 15 of those patients, Dr. Bhatia said.
In his view, it will take more time, greater awareness of the rosacea-SIBO link, and a willingness “to take chances” for more dermatologists to consider SIBO during rosacea care. “Breath tests are not something used in the [typical dermatology] clinic right now, but they may make their way in,” he said at the meeting.
In a follow-up interview, Dr. Bhatia emphasized that “it’s really a question of uptake, which always takes a while” and of willingness to “think through the disease from another angle ... especially in patients who are recalcitrant.”
Treatment
Dr. Sivamani said in the interview that a third type of SIBO – hydrogen sulfide–dominant SIBO – is now documented and worth considering when glucose and lactulose breath tests are negative in patients with rosacea who have gastrointestinal symptoms.
The use of breath tests to objectively diagnose SIBO is always best, Dr. Sivamani said, but he will consider empiric therapy in some patients. “I always tell patients [about] the benefits of testing, but if they can’t get the test covered or are unable to pay for the test, and they have symptoms consistent with SIBO, I’m okay doing a trial with therapy,” he said.
Rifaximin, one of the suggested antibiotics listed in the AGA guideline, is a nonabsorbable antibiotic that is FDA-approved for IBS with diarrhea (IBS-D); it has been shown to not negatively affect the growth of beneficial bacteria in the colon.
However, herbals are also an attractive option – alone or in combination with rifaximin or other antibiotics – speakers at the meeting said. In a multicenter retrospective chart review led by investigators at the Johns Hopkins Hospital, herbal therapies were at least as effective as rifaximin for treating SIBO, with similar safety profiles. The response rate for normalizing breath hydrogen testing in patients with SIBO was 46% for herbal therapies and 34% for rifaximin.
Dietary change is also part of treatment, with the reduction of fermentable carbohydrates – often through the Low FODMAP Diet and Specific Carbohydrate Diet – being the dominant theme in dietary intervention for SIBO, according to the AGA guideline.
“There are definitely some food choices you can shift,” said Dr. Sivamani. “I’ll work with patients on FODMAP, though it’s hard to sustain over the long-term and can induce psychological issues. You have to provide other options.”
Dr. Sivamani works with patients on using “a restrictive diet for a short amount of time, with the gradual reintroduction of foods to see [what] foods are and aren’t [causing] flares.” He also works to identify and eliminate risk factors and predisposing factors for SIBO so that recurrence will be less likely.
“SIBO is definitely an entity that is not on the fringes anymore ... it adds to inflammation in the body ... and if you have an inflamed gut, there’s a domino effect that will lead to inflammation elsewhere,” Dr. Sivamani said.
“You want to know, do your patients have SIBO? What subset do they have? Do they have risk factors you can eliminate?” he said. “And then what therapies will you use – pharmaceuticals, supplements and botanicals, or a combination? And finally, what will you do with diet?”
Dr. Bhatia disclosed he has affiliations with Abbvie, Almirall, Arcutis, Arena, Biofrontera, BMS, BI, Brickell, Dermavant, EPI Health, Ferndale, Galderma, Genentech, InCyte, ISDIN, Johnson & Johnson, LaRoche-Posay, Leo, Lilly, Novartis, Ortho, Pfizer, Proctor & Gamble, Regeneron, Sanofi, Stemline, SunPharma, and Verrica. Dr. Sivamani did not provide a disclosure statement.
, according to speakers at the annual Integrative Dermatology Symposium.
“SIBO is definitely something we test for and treat,” Raja Sivamani, MD, said in an interview after the meeting. Dr. Sivamani practices as an integrative dermatologist at the Pacific Skin Institute in Sacramento and is the director of clinical research at the institute’s research unit, Integrative Skin Science and Research. He led a panel discussion on rosacea and acne at the meeting.
Associations between SIBO and several dermatologic conditions, including systemic sclerosis, have been reported, but the strongest evidence to date involves rosacea. “There’s associative epidemiological evidence showing higher rates of SIBO among those with rosacea, and there are prospective studies” showing clearance of rosacea in patients treated for SIBO, said Dr. Sivamani, also adjunct associate professor of clinical dermatology at the University of California, Davis.
Studies are small, but are “well done and well-designed,” he said in the interview. “Do we need more studies? Absolutely. But what we have now is compelling [enough] for us to take a look at it.”
Findings of rosacea clearance
SIBO’s believed contribution to the pathophysiology of rosacea is part of the increasingly described gut microbiome-skin axis. SIBO has been recognized as a medical phenomenon for many decades and has been defined as an excessive bacterial load in the small bowel that causes gastrointestinal symptoms, according to the 2020 American College of Gastroenterology clinical guideline on SIBO.
Symptoms commonly associated with SIBO overlap with the cardinal symptoms of irritable bowel syndrome (IBS): abdominal pain; diarrhea, constipation, or both; bloating; and flatulence. SIBO can be diagnosed with several validated carbohydrate substrate (glucose or lactulose)–based breath tests that measure hydrogen and/or methane.
Hydrogen-positive breath tests suggest bacterial overgrowth, and methane-positive breath tests suggest small intestinal methanogen overgrowth. Methane is increasingly important and recognized, the AGA guideline says, though it creates a “nomenclature problem in the SIBO framework” because methanogens are not bacteria, the authors note.
In conventional practice, SIBO is typically treated with antibiotics such as rifaximin, and often with short-term dietary modification as well. Integrative medicine typically considers the use of supplements and botanicals in addition to or instead of antibiotics, as well as dietary change and increasingly, a close look at SIBO risk factors to prevent recurrence, Dr. Sivamani said. (His research unit is currently studying the use of herbal protocols as an alternative to antibiotics in patients with SIBO and dermatologic conditions.)
During a presentation on rosacea at the meeting, Neal Bhatia, MD, director of clinical dermatology at Therapeutics Clinical Research, a dermatology treatment and research center in San Diego, said that currently available breath tests for SIBO “are very interesting tools for understanding what may be happening in the gut” and that the “rifaximin data are good.”
He referred to a study reported in the Journal of the American Academy of Dermatology showing that patients with rosacea were significantly more likely to have SIBO (41.7% of 48 patients vs. 5.0% of 40 controls; P < .001), and that 64.5% of rosacea patients who completed treatment with rifaximin had remission of rosacea at a 3-year follow-up.
An earlier crossover study is also notable, he said. This study enrolled 113 consecutive patients with rosacea and 60 age- and sex-matched controls, and randomized those with SIBO (52 of the 113 with rosacea vs. 3 of the 60 controls) to rifaximin or placebo. Rosacea cleared in 20 of the 28 patients in the rifaximin group and greatly improved in 6 of the 28. Of 20 patients in the placebo group, rosacea remained unchanged in 18 and worsened in 2. When patients in the placebo group were switched to rifaximin, SIBO was eradicated in 17 of the 20, and rosacea completely resolved in 15 of those patients, Dr. Bhatia said.
In his view, it will take more time, greater awareness of the rosacea-SIBO link, and a willingness “to take chances” for more dermatologists to consider SIBO during rosacea care. “Breath tests are not something used in the [typical dermatology] clinic right now, but they may make their way in,” he said at the meeting.
In a follow-up interview, Dr. Bhatia emphasized that “it’s really a question of uptake, which always takes a while” and of willingness to “think through the disease from another angle ... especially in patients who are recalcitrant.”
Treatment
Dr. Sivamani said in the interview that a third type of SIBO – hydrogen sulfide–dominant SIBO – is now documented and worth considering when glucose and lactulose breath tests are negative in patients with rosacea who have gastrointestinal symptoms.
The use of breath tests to objectively diagnose SIBO is always best, Dr. Sivamani said, but he will consider empiric therapy in some patients. “I always tell patients [about] the benefits of testing, but if they can’t get the test covered or are unable to pay for the test, and they have symptoms consistent with SIBO, I’m okay doing a trial with therapy,” he said.
Rifaximin, one of the suggested antibiotics listed in the AGA guideline, is a nonabsorbable antibiotic that is FDA-approved for IBS with diarrhea (IBS-D); it has been shown to not negatively affect the growth of beneficial bacteria in the colon.
However, herbals are also an attractive option – alone or in combination with rifaximin or other antibiotics – speakers at the meeting said. In a multicenter retrospective chart review led by investigators at the Johns Hopkins Hospital, herbal therapies were at least as effective as rifaximin for treating SIBO, with similar safety profiles. The response rate for normalizing breath hydrogen testing in patients with SIBO was 46% for herbal therapies and 34% for rifaximin.
Dietary change is also part of treatment, with the reduction of fermentable carbohydrates – often through the Low FODMAP Diet and Specific Carbohydrate Diet – being the dominant theme in dietary intervention for SIBO, according to the AGA guideline.
“There are definitely some food choices you can shift,” said Dr. Sivamani. “I’ll work with patients on FODMAP, though it’s hard to sustain over the long-term and can induce psychological issues. You have to provide other options.”
Dr. Sivamani works with patients on using “a restrictive diet for a short amount of time, with the gradual reintroduction of foods to see [what] foods are and aren’t [causing] flares.” He also works to identify and eliminate risk factors and predisposing factors for SIBO so that recurrence will be less likely.
“SIBO is definitely an entity that is not on the fringes anymore ... it adds to inflammation in the body ... and if you have an inflamed gut, there’s a domino effect that will lead to inflammation elsewhere,” Dr. Sivamani said.
“You want to know, do your patients have SIBO? What subset do they have? Do they have risk factors you can eliminate?” he said. “And then what therapies will you use – pharmaceuticals, supplements and botanicals, or a combination? And finally, what will you do with diet?”
Dr. Bhatia disclosed he has affiliations with Abbvie, Almirall, Arcutis, Arena, Biofrontera, BMS, BI, Brickell, Dermavant, EPI Health, Ferndale, Galderma, Genentech, InCyte, ISDIN, Johnson & Johnson, LaRoche-Posay, Leo, Lilly, Novartis, Ortho, Pfizer, Proctor & Gamble, Regeneron, Sanofi, Stemline, SunPharma, and Verrica. Dr. Sivamani did not provide a disclosure statement.
, according to speakers at the annual Integrative Dermatology Symposium.
“SIBO is definitely something we test for and treat,” Raja Sivamani, MD, said in an interview after the meeting. Dr. Sivamani practices as an integrative dermatologist at the Pacific Skin Institute in Sacramento and is the director of clinical research at the institute’s research unit, Integrative Skin Science and Research. He led a panel discussion on rosacea and acne at the meeting.
Associations between SIBO and several dermatologic conditions, including systemic sclerosis, have been reported, but the strongest evidence to date involves rosacea. “There’s associative epidemiological evidence showing higher rates of SIBO among those with rosacea, and there are prospective studies” showing clearance of rosacea in patients treated for SIBO, said Dr. Sivamani, also adjunct associate professor of clinical dermatology at the University of California, Davis.
Studies are small, but are “well done and well-designed,” he said in the interview. “Do we need more studies? Absolutely. But what we have now is compelling [enough] for us to take a look at it.”
Findings of rosacea clearance
SIBO’s believed contribution to the pathophysiology of rosacea is part of the increasingly described gut microbiome-skin axis. SIBO has been recognized as a medical phenomenon for many decades and has been defined as an excessive bacterial load in the small bowel that causes gastrointestinal symptoms, according to the 2020 American College of Gastroenterology clinical guideline on SIBO.
Symptoms commonly associated with SIBO overlap with the cardinal symptoms of irritable bowel syndrome (IBS): abdominal pain; diarrhea, constipation, or both; bloating; and flatulence. SIBO can be diagnosed with several validated carbohydrate substrate (glucose or lactulose)–based breath tests that measure hydrogen and/or methane.
Hydrogen-positive breath tests suggest bacterial overgrowth, and methane-positive breath tests suggest small intestinal methanogen overgrowth. Methane is increasingly important and recognized, the AGA guideline says, though it creates a “nomenclature problem in the SIBO framework” because methanogens are not bacteria, the authors note.
In conventional practice, SIBO is typically treated with antibiotics such as rifaximin, and often with short-term dietary modification as well. Integrative medicine typically considers the use of supplements and botanicals in addition to or instead of antibiotics, as well as dietary change and increasingly, a close look at SIBO risk factors to prevent recurrence, Dr. Sivamani said. (His research unit is currently studying the use of herbal protocols as an alternative to antibiotics in patients with SIBO and dermatologic conditions.)
During a presentation on rosacea at the meeting, Neal Bhatia, MD, director of clinical dermatology at Therapeutics Clinical Research, a dermatology treatment and research center in San Diego, said that currently available breath tests for SIBO “are very interesting tools for understanding what may be happening in the gut” and that the “rifaximin data are good.”
He referred to a study reported in the Journal of the American Academy of Dermatology showing that patients with rosacea were significantly more likely to have SIBO (41.7% of 48 patients vs. 5.0% of 40 controls; P < .001), and that 64.5% of rosacea patients who completed treatment with rifaximin had remission of rosacea at a 3-year follow-up.
An earlier crossover study is also notable, he said. This study enrolled 113 consecutive patients with rosacea and 60 age- and sex-matched controls, and randomized those with SIBO (52 of the 113 with rosacea vs. 3 of the 60 controls) to rifaximin or placebo. Rosacea cleared in 20 of the 28 patients in the rifaximin group and greatly improved in 6 of the 28. Of 20 patients in the placebo group, rosacea remained unchanged in 18 and worsened in 2. When patients in the placebo group were switched to rifaximin, SIBO was eradicated in 17 of the 20, and rosacea completely resolved in 15 of those patients, Dr. Bhatia said.
In his view, it will take more time, greater awareness of the rosacea-SIBO link, and a willingness “to take chances” for more dermatologists to consider SIBO during rosacea care. “Breath tests are not something used in the [typical dermatology] clinic right now, but they may make their way in,” he said at the meeting.
In a follow-up interview, Dr. Bhatia emphasized that “it’s really a question of uptake, which always takes a while” and of willingness to “think through the disease from another angle ... especially in patients who are recalcitrant.”
Treatment
Dr. Sivamani said in the interview that a third type of SIBO – hydrogen sulfide–dominant SIBO – is now documented and worth considering when glucose and lactulose breath tests are negative in patients with rosacea who have gastrointestinal symptoms.
The use of breath tests to objectively diagnose SIBO is always best, Dr. Sivamani said, but he will consider empiric therapy in some patients. “I always tell patients [about] the benefits of testing, but if they can’t get the test covered or are unable to pay for the test, and they have symptoms consistent with SIBO, I’m okay doing a trial with therapy,” he said.
Rifaximin, one of the suggested antibiotics listed in the AGA guideline, is a nonabsorbable antibiotic that is FDA-approved for IBS with diarrhea (IBS-D); it has been shown to not negatively affect the growth of beneficial bacteria in the colon.
However, herbals are also an attractive option – alone or in combination with rifaximin or other antibiotics – speakers at the meeting said. In a multicenter retrospective chart review led by investigators at the Johns Hopkins Hospital, herbal therapies were at least as effective as rifaximin for treating SIBO, with similar safety profiles. The response rate for normalizing breath hydrogen testing in patients with SIBO was 46% for herbal therapies and 34% for rifaximin.
Dietary change is also part of treatment, with the reduction of fermentable carbohydrates – often through the Low FODMAP Diet and Specific Carbohydrate Diet – being the dominant theme in dietary intervention for SIBO, according to the AGA guideline.
“There are definitely some food choices you can shift,” said Dr. Sivamani. “I’ll work with patients on FODMAP, though it’s hard to sustain over the long-term and can induce psychological issues. You have to provide other options.”
Dr. Sivamani works with patients on using “a restrictive diet for a short amount of time, with the gradual reintroduction of foods to see [what] foods are and aren’t [causing] flares.” He also works to identify and eliminate risk factors and predisposing factors for SIBO so that recurrence will be less likely.
“SIBO is definitely an entity that is not on the fringes anymore ... it adds to inflammation in the body ... and if you have an inflamed gut, there’s a domino effect that will lead to inflammation elsewhere,” Dr. Sivamani said.
“You want to know, do your patients have SIBO? What subset do they have? Do they have risk factors you can eliminate?” he said. “And then what therapies will you use – pharmaceuticals, supplements and botanicals, or a combination? And finally, what will you do with diet?”
Dr. Bhatia disclosed he has affiliations with Abbvie, Almirall, Arcutis, Arena, Biofrontera, BMS, BI, Brickell, Dermavant, EPI Health, Ferndale, Galderma, Genentech, InCyte, ISDIN, Johnson & Johnson, LaRoche-Posay, Leo, Lilly, Novartis, Ortho, Pfizer, Proctor & Gamble, Regeneron, Sanofi, Stemline, SunPharma, and Verrica. Dr. Sivamani did not provide a disclosure statement.
REPORTING FROM IDS 2022
Consider gaps in access and knowledge in diagnosis and treatment in skin of color
LAS VEGAS –
and patients, Susan C. Taylor, MD, said in a presentation at MedscapeLive’s annual Las Vegas Dermatology Seminar.Additionally, some disparities occur because of gaps in access to health care, said Dr. Taylor, vice chair, diversity, equity and inclusion, in the department of dermatology at the University of Pennsylvania, Philadelphia, who moderated an expert panel discussion of treatment tips for several common dermatologic conditions in skin of color patients.
Atopic dermatitis angles
Atopic dermatitis (AD) is the fourth most common dermatologic complaint in Black patients, based on data from the United States National Ambulatory Medical Care Survey. Also, data from the National Health and Nutrition Examination Survey show that Black children are nearly twice as likely as White children to develop AD after controlling for socioeconomic factors, Dr. Taylor said.
When Black patients present with AD, “you may not see the erythema,” said Valerie D. Callender, MD, of Howard University, Washington, who presented on AD. Instead, “you may see more follicular and papular presentations.” Erythema and erythroderma can present as shades of violet, gray, or dark brown in patients with rich skin tones, added Dr. Callender, who practices in Glenn Dale, Md.
Consequently, disease severity can be misinterpreted, she said, noting that data suggest that scoring systems such as the Eczema Area and Severity Index and Scoring Atopic Dermatitis underestimate AD severity in dark skin.
As for treatment, skin of color patients with AD are often as bothered by postinflammatory hyperpigmentation (PIH) as by active lesions, so treatment should take these concerns into account, Dr. Callender said. Studies evaluating the effectiveness of AD treatments in diverse populations are limited by lack of representation of racial groups in clinical trials and lack of subset analyses by race.
Acne awareness
An important consideration of acne in skin of color patients is that the acne “might not be red, it might just be darker,” said Andrew F. Alexis, MD, vice-chair for diversity and inclusion in the department of dermatology, and professor of clinical dermatology at Weill Cornell Medicine, New York. A study published in JAMA Dermatology of nearly 30,000 patients with acne from 2007 to 2017 found that non-Hispanic Black patients were more likely than non-Hispanic White patients to see a dermatologist for acne, but Black patients received fewer prescriptions for acne medications than White patients.
The study also showed that Black patients who received prescriptions for acne were more likely to receive topical retinoids and topical antibiotics, and less likely to receive oral antibiotics, spironolactone, or isotretinoin, compared with White patients. Similarly, Asian patients were more likely to receive topical antibiotics and less likely to receive oral antibiotics, compared with White patients.
Other panelists shared some of their best practices for acne in patients with skin of color, including treatment with topical retinoids (for inflammation) and spironolactone, and therapies that address both inflammation and pigmentation, such as salicylic acid and azelaic acid. Dr. Callender also advised asking patients about makeup, as they may not know that many types of makeup used to cover acne are in fact comedogenic.
Melanoma misconceptions
One of the most common misperceptions about melanoma among skin of color patients is that they don’t think they can get it, Dr. Taylor said. Many health care providers don’t think about melanoma in skin of color patients because of the dramatically lower incidence in this population, but as a result, cases may go undiagnosed, and as studies have shown, the mortality rate from melanoma is higher in Black patients.
Consider the palms, soles, nails, and web spaces as possible melanoma sites, Dr. Taylor added.
Educating skin of color patients about melanoma is important, although the incidence is 20 to 30 times lower than in non-Hispanic Whites, said Nada Elbuluk, MD, the founder and director of the University of Southern California Skin of Color Center and Pigmentary Disorders Clinic, Los Angeles. A 2020 editorial published in Cancer Cytopathology pointed out that 1 in 3 Black men or women with a melanoma diagnosis in the United States dies of the disease, compared with 1 in 7 non-Hispanic White men and 1 in 11 non-Hispanic White women with melanoma.
Don’t skip the total body skin exam in these patients, Dr. Elbuluk emphasized. Many patients will only partially undress, and areas such as toes can be missed.
Rosacea review
For patients with skin of color, clinicians need to look for different signs of rosacea than those typically seen in White patients, Dr. Elbuluk said. “The most common presentation of rosacea in skin of color is papulopustular,” and the granulomatous variant.
“These patients will often give you a history of sensitivity to products,” Dr. Elbuluk noted. They may not always have the flushing, but they may report warmth or itching, in addition to product sensitivity.
When considering rosacea in skin of color patients, be sure to have good lighting for close examination, as skin thickening is another subtle sign of rosacea in these patients, she said. Skin thickening “is a very early sign that will present in skin of color with no erythema, so keep that in mind.”
Stinging and burning sensations may be reported by skin of color patients with rosacea. Use patient history to confirm the diagnosis of rosacea, which is often delayed in skin of color patients because of a low index of suspicion, she said.
Psoriasis pointers
Psoriasis in skin of color patients used to be considered rare, “but that is far from true,” Dr. Alexis said. In fact, many cases of psoriasis are undiagnosed or the diagnosis is delayed in these patients.
The panelists noted that current guidelines for psoriasis treatment are based on clinical trials composed mainly of White patients, and do not contain specific recommendations for skin of color patients.
Notably, the morphology, location, and color of psoriasis lesions may be different for patients with darker skin, such as thicker plaques and more scaling over larger areas, they said. Also, skin of color patients may experience long-lasting dyspigmentation from psoriasis lesions that have resolved.
When developing a strategy for psoriasis in skin of color patients, consider not only disease severity, but also comorbidities and medications, response (if any) to prior therapies, patient preferences, and quality of life, the panelists said.
Dr. Callender, Dr. Elbuluk, Dr. Taylor, and Dr. Alexis reported conflicts of interest from numerous sources in industry. MedscapeLive and this news organization are owned by the same parent company.
LAS VEGAS –
and patients, Susan C. Taylor, MD, said in a presentation at MedscapeLive’s annual Las Vegas Dermatology Seminar.Additionally, some disparities occur because of gaps in access to health care, said Dr. Taylor, vice chair, diversity, equity and inclusion, in the department of dermatology at the University of Pennsylvania, Philadelphia, who moderated an expert panel discussion of treatment tips for several common dermatologic conditions in skin of color patients.
Atopic dermatitis angles
Atopic dermatitis (AD) is the fourth most common dermatologic complaint in Black patients, based on data from the United States National Ambulatory Medical Care Survey. Also, data from the National Health and Nutrition Examination Survey show that Black children are nearly twice as likely as White children to develop AD after controlling for socioeconomic factors, Dr. Taylor said.
When Black patients present with AD, “you may not see the erythema,” said Valerie D. Callender, MD, of Howard University, Washington, who presented on AD. Instead, “you may see more follicular and papular presentations.” Erythema and erythroderma can present as shades of violet, gray, or dark brown in patients with rich skin tones, added Dr. Callender, who practices in Glenn Dale, Md.
Consequently, disease severity can be misinterpreted, she said, noting that data suggest that scoring systems such as the Eczema Area and Severity Index and Scoring Atopic Dermatitis underestimate AD severity in dark skin.
As for treatment, skin of color patients with AD are often as bothered by postinflammatory hyperpigmentation (PIH) as by active lesions, so treatment should take these concerns into account, Dr. Callender said. Studies evaluating the effectiveness of AD treatments in diverse populations are limited by lack of representation of racial groups in clinical trials and lack of subset analyses by race.
Acne awareness
An important consideration of acne in skin of color patients is that the acne “might not be red, it might just be darker,” said Andrew F. Alexis, MD, vice-chair for diversity and inclusion in the department of dermatology, and professor of clinical dermatology at Weill Cornell Medicine, New York. A study published in JAMA Dermatology of nearly 30,000 patients with acne from 2007 to 2017 found that non-Hispanic Black patients were more likely than non-Hispanic White patients to see a dermatologist for acne, but Black patients received fewer prescriptions for acne medications than White patients.
The study also showed that Black patients who received prescriptions for acne were more likely to receive topical retinoids and topical antibiotics, and less likely to receive oral antibiotics, spironolactone, or isotretinoin, compared with White patients. Similarly, Asian patients were more likely to receive topical antibiotics and less likely to receive oral antibiotics, compared with White patients.
Other panelists shared some of their best practices for acne in patients with skin of color, including treatment with topical retinoids (for inflammation) and spironolactone, and therapies that address both inflammation and pigmentation, such as salicylic acid and azelaic acid. Dr. Callender also advised asking patients about makeup, as they may not know that many types of makeup used to cover acne are in fact comedogenic.
Melanoma misconceptions
One of the most common misperceptions about melanoma among skin of color patients is that they don’t think they can get it, Dr. Taylor said. Many health care providers don’t think about melanoma in skin of color patients because of the dramatically lower incidence in this population, but as a result, cases may go undiagnosed, and as studies have shown, the mortality rate from melanoma is higher in Black patients.
Consider the palms, soles, nails, and web spaces as possible melanoma sites, Dr. Taylor added.
Educating skin of color patients about melanoma is important, although the incidence is 20 to 30 times lower than in non-Hispanic Whites, said Nada Elbuluk, MD, the founder and director of the University of Southern California Skin of Color Center and Pigmentary Disorders Clinic, Los Angeles. A 2020 editorial published in Cancer Cytopathology pointed out that 1 in 3 Black men or women with a melanoma diagnosis in the United States dies of the disease, compared with 1 in 7 non-Hispanic White men and 1 in 11 non-Hispanic White women with melanoma.
Don’t skip the total body skin exam in these patients, Dr. Elbuluk emphasized. Many patients will only partially undress, and areas such as toes can be missed.
Rosacea review
For patients with skin of color, clinicians need to look for different signs of rosacea than those typically seen in White patients, Dr. Elbuluk said. “The most common presentation of rosacea in skin of color is papulopustular,” and the granulomatous variant.
“These patients will often give you a history of sensitivity to products,” Dr. Elbuluk noted. They may not always have the flushing, but they may report warmth or itching, in addition to product sensitivity.
When considering rosacea in skin of color patients, be sure to have good lighting for close examination, as skin thickening is another subtle sign of rosacea in these patients, she said. Skin thickening “is a very early sign that will present in skin of color with no erythema, so keep that in mind.”
Stinging and burning sensations may be reported by skin of color patients with rosacea. Use patient history to confirm the diagnosis of rosacea, which is often delayed in skin of color patients because of a low index of suspicion, she said.
Psoriasis pointers
Psoriasis in skin of color patients used to be considered rare, “but that is far from true,” Dr. Alexis said. In fact, many cases of psoriasis are undiagnosed or the diagnosis is delayed in these patients.
The panelists noted that current guidelines for psoriasis treatment are based on clinical trials composed mainly of White patients, and do not contain specific recommendations for skin of color patients.
Notably, the morphology, location, and color of psoriasis lesions may be different for patients with darker skin, such as thicker plaques and more scaling over larger areas, they said. Also, skin of color patients may experience long-lasting dyspigmentation from psoriasis lesions that have resolved.
When developing a strategy for psoriasis in skin of color patients, consider not only disease severity, but also comorbidities and medications, response (if any) to prior therapies, patient preferences, and quality of life, the panelists said.
Dr. Callender, Dr. Elbuluk, Dr. Taylor, and Dr. Alexis reported conflicts of interest from numerous sources in industry. MedscapeLive and this news organization are owned by the same parent company.
LAS VEGAS –
and patients, Susan C. Taylor, MD, said in a presentation at MedscapeLive’s annual Las Vegas Dermatology Seminar.Additionally, some disparities occur because of gaps in access to health care, said Dr. Taylor, vice chair, diversity, equity and inclusion, in the department of dermatology at the University of Pennsylvania, Philadelphia, who moderated an expert panel discussion of treatment tips for several common dermatologic conditions in skin of color patients.
Atopic dermatitis angles
Atopic dermatitis (AD) is the fourth most common dermatologic complaint in Black patients, based on data from the United States National Ambulatory Medical Care Survey. Also, data from the National Health and Nutrition Examination Survey show that Black children are nearly twice as likely as White children to develop AD after controlling for socioeconomic factors, Dr. Taylor said.
When Black patients present with AD, “you may not see the erythema,” said Valerie D. Callender, MD, of Howard University, Washington, who presented on AD. Instead, “you may see more follicular and papular presentations.” Erythema and erythroderma can present as shades of violet, gray, or dark brown in patients with rich skin tones, added Dr. Callender, who practices in Glenn Dale, Md.
Consequently, disease severity can be misinterpreted, she said, noting that data suggest that scoring systems such as the Eczema Area and Severity Index and Scoring Atopic Dermatitis underestimate AD severity in dark skin.
As for treatment, skin of color patients with AD are often as bothered by postinflammatory hyperpigmentation (PIH) as by active lesions, so treatment should take these concerns into account, Dr. Callender said. Studies evaluating the effectiveness of AD treatments in diverse populations are limited by lack of representation of racial groups in clinical trials and lack of subset analyses by race.
Acne awareness
An important consideration of acne in skin of color patients is that the acne “might not be red, it might just be darker,” said Andrew F. Alexis, MD, vice-chair for diversity and inclusion in the department of dermatology, and professor of clinical dermatology at Weill Cornell Medicine, New York. A study published in JAMA Dermatology of nearly 30,000 patients with acne from 2007 to 2017 found that non-Hispanic Black patients were more likely than non-Hispanic White patients to see a dermatologist for acne, but Black patients received fewer prescriptions for acne medications than White patients.
The study also showed that Black patients who received prescriptions for acne were more likely to receive topical retinoids and topical antibiotics, and less likely to receive oral antibiotics, spironolactone, or isotretinoin, compared with White patients. Similarly, Asian patients were more likely to receive topical antibiotics and less likely to receive oral antibiotics, compared with White patients.
Other panelists shared some of their best practices for acne in patients with skin of color, including treatment with topical retinoids (for inflammation) and spironolactone, and therapies that address both inflammation and pigmentation, such as salicylic acid and azelaic acid. Dr. Callender also advised asking patients about makeup, as they may not know that many types of makeup used to cover acne are in fact comedogenic.
Melanoma misconceptions
One of the most common misperceptions about melanoma among skin of color patients is that they don’t think they can get it, Dr. Taylor said. Many health care providers don’t think about melanoma in skin of color patients because of the dramatically lower incidence in this population, but as a result, cases may go undiagnosed, and as studies have shown, the mortality rate from melanoma is higher in Black patients.
Consider the palms, soles, nails, and web spaces as possible melanoma sites, Dr. Taylor added.
Educating skin of color patients about melanoma is important, although the incidence is 20 to 30 times lower than in non-Hispanic Whites, said Nada Elbuluk, MD, the founder and director of the University of Southern California Skin of Color Center and Pigmentary Disorders Clinic, Los Angeles. A 2020 editorial published in Cancer Cytopathology pointed out that 1 in 3 Black men or women with a melanoma diagnosis in the United States dies of the disease, compared with 1 in 7 non-Hispanic White men and 1 in 11 non-Hispanic White women with melanoma.
Don’t skip the total body skin exam in these patients, Dr. Elbuluk emphasized. Many patients will only partially undress, and areas such as toes can be missed.
Rosacea review
For patients with skin of color, clinicians need to look for different signs of rosacea than those typically seen in White patients, Dr. Elbuluk said. “The most common presentation of rosacea in skin of color is papulopustular,” and the granulomatous variant.
“These patients will often give you a history of sensitivity to products,” Dr. Elbuluk noted. They may not always have the flushing, but they may report warmth or itching, in addition to product sensitivity.
When considering rosacea in skin of color patients, be sure to have good lighting for close examination, as skin thickening is another subtle sign of rosacea in these patients, she said. Skin thickening “is a very early sign that will present in skin of color with no erythema, so keep that in mind.”
Stinging and burning sensations may be reported by skin of color patients with rosacea. Use patient history to confirm the diagnosis of rosacea, which is often delayed in skin of color patients because of a low index of suspicion, she said.
Psoriasis pointers
Psoriasis in skin of color patients used to be considered rare, “but that is far from true,” Dr. Alexis said. In fact, many cases of psoriasis are undiagnosed or the diagnosis is delayed in these patients.
The panelists noted that current guidelines for psoriasis treatment are based on clinical trials composed mainly of White patients, and do not contain specific recommendations for skin of color patients.
Notably, the morphology, location, and color of psoriasis lesions may be different for patients with darker skin, such as thicker plaques and more scaling over larger areas, they said. Also, skin of color patients may experience long-lasting dyspigmentation from psoriasis lesions that have resolved.
When developing a strategy for psoriasis in skin of color patients, consider not only disease severity, but also comorbidities and medications, response (if any) to prior therapies, patient preferences, and quality of life, the panelists said.
Dr. Callender, Dr. Elbuluk, Dr. Taylor, and Dr. Alexis reported conflicts of interest from numerous sources in industry. MedscapeLive and this news organization are owned by the same parent company.
AT INNOVATIONS IN DERMATOLOGY
Education about OTC tools key for patients with acne and rosacea
LAS VEGAS – , Hilary E. Baldwin, MD, of Rutgers Robert Wood Johnson Medical Center, New Brunswick, N.J., said in a presentation at Medscape Live’s annual Las Vegas Dermatology Seminar.
In some cases, the use of good-quality over-the -counter skin care products can improve acne without prescription treatment, said Dr. Baldwin, who is medical director of the Acne Treatment and Research Center, New York. Good skin care can enhance the effects of prescription medication by decreasing side effects such as inflammation, pain, and erythema, and improving compliance; and use of OTC products has not been shown to interfere with the efficacy of prescription products, she noted.
However, patient education about OTC products is key, she said. In particular, “cleansers are a double-edged sword,” Dr. Baldwin emphasized.
Cleansing is important to preserve barrier function, but “there is a risk of skin damage” if cleansers are too harsh, she said. The goal is to remove dirt, oils, and bacteria without disrupting the lipids, proteins, and normal flora that keep skin healthy, and to avoid altering pH, she added.
Key considerations for OTC cleansers include surfactants, pH, and patient preferences, Dr. Baldwin said.
Surfactants, the main components of OTC cleansers, can do more harm than good in some cases. Surfactants break down impurities on the skin surface, but not all are created equal, and some may cause skin irritation, she explained.
Surfactants fall into four categories: nonionic (no charge), anionic (negative charge), cationic (positive charge), and amphoteric (dual charge). Of these, cationic surfactants have the highest level of antimicrobial activity.
Many patients with acne seek out antibacterial cleansers, but many of these products have a high pH, which can inhibit healthy skin function and promote inflammation, Dr. Baldwin noted.
The right OTC skin care products can normalize pH, which promotes repair of the skin barrier and reduces inflammation, she said. While some products are labeled as “gentle,” they may have a high pH, and many products don’t list a pH, Dr. Baldwin pointed out. Many antibacterial products have pH levels in the 10-12 range, while true soaps fall in the 9-10 range, and hydrating liquid cleansers often land in the 5-7 range, she said.
“Most of our patients don’t know what ingredients to look for” in a cleanser, she noted. However, data show that a majority of patients prefer a foaming cleanser, enjoy the face-washing experience – and wash their faces at least twice a day, with a range of products including bath soap, said Dr. Baldwin. Consequently, “educate your patient about moisturizing,” she advised.
For patients with greasy or oily skin, Dr. Baldwin recommends lipid-free foaming cleansers, such as those with ceramides or glycerin. For patients with dry, irritated acne, she advises once-daily washing only, without cleansing devices, which includes washcloths, she said. Look for hydrating cleansers that are nonfoaming or slightly foaming for these patients, she added.
Another tip for patients is to remind them that “sebum is not a moisturizer,” said Dr. Baldwin. Acne patients may still need moisturizers, especially if they experience dry skin as a side effect of their acne medication, but finding the right fit can be a challenge requiring some trial and error, she noted.
OTC products for rosacea
Dr. Baldwin also addressed the use of OTC products for patients with rosacea. For cleansers, she recommends the same hydrating, nonfoaming categories as for her acne patients, with a once-daily, no-device regimen. She advises rosacea patients to avoid pure humectants for moisturizing and noted that silicone-based products are often the least irritating.
Seek moisturizers with ceramides, hyaluronic acid, glycerin, or niacinamide, she said. Data have shown that effective moisturization improves the ability of patients with rosacea to use and adhere to their prescription medications, Dr. Baldwin emphasized. Moisturizers also can make the medication more effective by enhancing the penetration of products such as azelaic acid, she added.
No acne or rosacea visit is complete until overall skin care has been discussed, Dr. Baldwin said.
Dr. Baldwin disclosed serving as a consultant or adviser for Almirall, EPI Health, Galderma, La Roche Posay, Ortho Dermatologics, Sun, and Vyne; and serving as a speaker or member of the speakers’ bureau for Almirall, Galderma, La Roche Posay, Ortho Dermatologics, and Sun. MedscapeLive and this news organization are owned by the same parent company.
LAS VEGAS – , Hilary E. Baldwin, MD, of Rutgers Robert Wood Johnson Medical Center, New Brunswick, N.J., said in a presentation at Medscape Live’s annual Las Vegas Dermatology Seminar.
In some cases, the use of good-quality over-the -counter skin care products can improve acne without prescription treatment, said Dr. Baldwin, who is medical director of the Acne Treatment and Research Center, New York. Good skin care can enhance the effects of prescription medication by decreasing side effects such as inflammation, pain, and erythema, and improving compliance; and use of OTC products has not been shown to interfere with the efficacy of prescription products, she noted.
However, patient education about OTC products is key, she said. In particular, “cleansers are a double-edged sword,” Dr. Baldwin emphasized.
Cleansing is important to preserve barrier function, but “there is a risk of skin damage” if cleansers are too harsh, she said. The goal is to remove dirt, oils, and bacteria without disrupting the lipids, proteins, and normal flora that keep skin healthy, and to avoid altering pH, she added.
Key considerations for OTC cleansers include surfactants, pH, and patient preferences, Dr. Baldwin said.
Surfactants, the main components of OTC cleansers, can do more harm than good in some cases. Surfactants break down impurities on the skin surface, but not all are created equal, and some may cause skin irritation, she explained.
Surfactants fall into four categories: nonionic (no charge), anionic (negative charge), cationic (positive charge), and amphoteric (dual charge). Of these, cationic surfactants have the highest level of antimicrobial activity.
Many patients with acne seek out antibacterial cleansers, but many of these products have a high pH, which can inhibit healthy skin function and promote inflammation, Dr. Baldwin noted.
The right OTC skin care products can normalize pH, which promotes repair of the skin barrier and reduces inflammation, she said. While some products are labeled as “gentle,” they may have a high pH, and many products don’t list a pH, Dr. Baldwin pointed out. Many antibacterial products have pH levels in the 10-12 range, while true soaps fall in the 9-10 range, and hydrating liquid cleansers often land in the 5-7 range, she said.
“Most of our patients don’t know what ingredients to look for” in a cleanser, she noted. However, data show that a majority of patients prefer a foaming cleanser, enjoy the face-washing experience – and wash their faces at least twice a day, with a range of products including bath soap, said Dr. Baldwin. Consequently, “educate your patient about moisturizing,” she advised.
For patients with greasy or oily skin, Dr. Baldwin recommends lipid-free foaming cleansers, such as those with ceramides or glycerin. For patients with dry, irritated acne, she advises once-daily washing only, without cleansing devices, which includes washcloths, she said. Look for hydrating cleansers that are nonfoaming or slightly foaming for these patients, she added.
Another tip for patients is to remind them that “sebum is not a moisturizer,” said Dr. Baldwin. Acne patients may still need moisturizers, especially if they experience dry skin as a side effect of their acne medication, but finding the right fit can be a challenge requiring some trial and error, she noted.
OTC products for rosacea
Dr. Baldwin also addressed the use of OTC products for patients with rosacea. For cleansers, she recommends the same hydrating, nonfoaming categories as for her acne patients, with a once-daily, no-device regimen. She advises rosacea patients to avoid pure humectants for moisturizing and noted that silicone-based products are often the least irritating.
Seek moisturizers with ceramides, hyaluronic acid, glycerin, or niacinamide, she said. Data have shown that effective moisturization improves the ability of patients with rosacea to use and adhere to their prescription medications, Dr. Baldwin emphasized. Moisturizers also can make the medication more effective by enhancing the penetration of products such as azelaic acid, she added.
No acne or rosacea visit is complete until overall skin care has been discussed, Dr. Baldwin said.
Dr. Baldwin disclosed serving as a consultant or adviser for Almirall, EPI Health, Galderma, La Roche Posay, Ortho Dermatologics, Sun, and Vyne; and serving as a speaker or member of the speakers’ bureau for Almirall, Galderma, La Roche Posay, Ortho Dermatologics, and Sun. MedscapeLive and this news organization are owned by the same parent company.
LAS VEGAS – , Hilary E. Baldwin, MD, of Rutgers Robert Wood Johnson Medical Center, New Brunswick, N.J., said in a presentation at Medscape Live’s annual Las Vegas Dermatology Seminar.
In some cases, the use of good-quality over-the -counter skin care products can improve acne without prescription treatment, said Dr. Baldwin, who is medical director of the Acne Treatment and Research Center, New York. Good skin care can enhance the effects of prescription medication by decreasing side effects such as inflammation, pain, and erythema, and improving compliance; and use of OTC products has not been shown to interfere with the efficacy of prescription products, she noted.
However, patient education about OTC products is key, she said. In particular, “cleansers are a double-edged sword,” Dr. Baldwin emphasized.
Cleansing is important to preserve barrier function, but “there is a risk of skin damage” if cleansers are too harsh, she said. The goal is to remove dirt, oils, and bacteria without disrupting the lipids, proteins, and normal flora that keep skin healthy, and to avoid altering pH, she added.
Key considerations for OTC cleansers include surfactants, pH, and patient preferences, Dr. Baldwin said.
Surfactants, the main components of OTC cleansers, can do more harm than good in some cases. Surfactants break down impurities on the skin surface, but not all are created equal, and some may cause skin irritation, she explained.
Surfactants fall into four categories: nonionic (no charge), anionic (negative charge), cationic (positive charge), and amphoteric (dual charge). Of these, cationic surfactants have the highest level of antimicrobial activity.
Many patients with acne seek out antibacterial cleansers, but many of these products have a high pH, which can inhibit healthy skin function and promote inflammation, Dr. Baldwin noted.
The right OTC skin care products can normalize pH, which promotes repair of the skin barrier and reduces inflammation, she said. While some products are labeled as “gentle,” they may have a high pH, and many products don’t list a pH, Dr. Baldwin pointed out. Many antibacterial products have pH levels in the 10-12 range, while true soaps fall in the 9-10 range, and hydrating liquid cleansers often land in the 5-7 range, she said.
“Most of our patients don’t know what ingredients to look for” in a cleanser, she noted. However, data show that a majority of patients prefer a foaming cleanser, enjoy the face-washing experience – and wash their faces at least twice a day, with a range of products including bath soap, said Dr. Baldwin. Consequently, “educate your patient about moisturizing,” she advised.
For patients with greasy or oily skin, Dr. Baldwin recommends lipid-free foaming cleansers, such as those with ceramides or glycerin. For patients with dry, irritated acne, she advises once-daily washing only, without cleansing devices, which includes washcloths, she said. Look for hydrating cleansers that are nonfoaming or slightly foaming for these patients, she added.
Another tip for patients is to remind them that “sebum is not a moisturizer,” said Dr. Baldwin. Acne patients may still need moisturizers, especially if they experience dry skin as a side effect of their acne medication, but finding the right fit can be a challenge requiring some trial and error, she noted.
OTC products for rosacea
Dr. Baldwin also addressed the use of OTC products for patients with rosacea. For cleansers, she recommends the same hydrating, nonfoaming categories as for her acne patients, with a once-daily, no-device regimen. She advises rosacea patients to avoid pure humectants for moisturizing and noted that silicone-based products are often the least irritating.
Seek moisturizers with ceramides, hyaluronic acid, glycerin, or niacinamide, she said. Data have shown that effective moisturization improves the ability of patients with rosacea to use and adhere to their prescription medications, Dr. Baldwin emphasized. Moisturizers also can make the medication more effective by enhancing the penetration of products such as azelaic acid, she added.
No acne or rosacea visit is complete until overall skin care has been discussed, Dr. Baldwin said.
Dr. Baldwin disclosed serving as a consultant or adviser for Almirall, EPI Health, Galderma, La Roche Posay, Ortho Dermatologics, Sun, and Vyne; and serving as a speaker or member of the speakers’ bureau for Almirall, Galderma, La Roche Posay, Ortho Dermatologics, and Sun. MedscapeLive and this news organization are owned by the same parent company.
AT INNOVATIONS IN DERMATOLOGY
Novel stepwise method found to benefit patients with severe rhinophyma
DENVER –
Rhinophyma occurs primarily in the sixth and seventh decades of life and is marked by facial hypertrophy that leads to tumor-like growth, inflammation, fibrosis, and loss of the cosmetic nasal subunits. “When it becomes severe it leads to a degree of embarrassment as well,” one of the study authors, Patricia Richey, MD, said during an oral abstract session at the annual meeting of the American Society for Dermatologic Surgery. “We found that our method has been efficacious, but most often, and more importantly, leads to an improvement in the patient’s quality of life.”
To date, clinicians have used fully ablative lasers to treat varying degrees of rhinophyma but at a cost of prolonged healing time and higher rates of scarring and pigment or textural changes. However, not all dermatologists use full-field ablative lasers in their practices.
“Fractionated ablative lasers have been used in the past for mild to moderate rhinophyma, but they cannot ablate to 100% density, which would be necessary to debulk the marked hypertrophy present in our patients,” said Dr. Richey, who practices Mohs surgery and cosmetic dermatology in Washington, D.C., and conducts research for the Wellman Center for Photomedicine and the Dermatology Laser and Cosmetic Center at Massachusetts General Hospital, Boston. “That’s why we added a surgical component.”
She and colleague Mathew M. Avram, MD, JD, developed a three-step method for treating severe rhinophyma that they performed on three elderly patients. Step 1 is the surgical debulk. Following infiltration of local anesthesia, a razor blade or 15-blade is used to excise the most prominent lobules of hypertrophied sebaceous tissue down to the fibrofatty layer of the nose as a partial thickness excision that does not reach the level of the perichondrium or cartilage. “Hemostasis is achieved with electrocoagulation and application of petrolatum ointment, followed by a pressure dressing,” Dr. Richey said. “The location of the debulk varies by patient.”
Step 2 involves fractionated ablative laser treatment 4 weeks later with either the CO2 or erbium:YAG (Er:YAG) 2,940-nm laser. According to Dr. Richey, the typical setting for the fractionated CO2 is a fluence of 70mJ/cm2 and a high density, performing six out of four passes with 60 seconds between each pass, “though these settings may vary based on the patient presentation,” she said.
The treatment level ranges from 5 (14% density) to 10 (70% density, for the most severe cases). Meanwhile, a representative setting for the ablative fractionated Er:YAG 2,940-nm laser is 250 mcm, no coagulation, 5.5% density, and one pass. “If a second surgical debulk is performed on the same day as ablative laser treatment, the sites of shave removal are typically avoided with the laser,” she said. If a certain portion of the nose has recently healed following surgical debulk 4 weeks prior, they may perform only two passes in this region.
In an interview, Dr. Avram, who directs the MGH Dermatology Laser and Cosmetic Center, characterized the staged method as providing “transformative change to severe, cosmetically disfiguring rhinophyma. The ablative fractional laser provides more fine-tuned contouring.”
The three patients studied had an average of three to four monthly treatments. “There is typically a great deal of improvement by the second treatment,” Dr. Richey said. Add-on treatments may include low voltage electrodessication at 1.8 watts for patients with well-demarcated papules of sebaceous hyperplasia, and a vascular laser such as the pulsed dye laser if telangiectasias are present.
One limitation of the stepwise method, she said, is that the surgical debulk typically results in a scar, “but it’s rarely noticeable if carefully performed, likely due to fractionated ablative use during the scar remodeling period. It’s important to set expectations with your patient at the initial consult. We always discuss treatment goals and that while we aim achieve the most desirable outcome possible, we’re never going to get them back to having a completely normal nose. They’re always going to have some mild or moderate rhinophymatous changes present.”
Vincent Richer, MD, a Vancouver-based medical and cosmetic dermatologist who was asked to comment on these results, characterized the stepwise method as promising. “Though more treatments are required, the easier recovery, safe outcomes in the case presented and excellent cosmetic result made it an interesting alternative when fully ablative resurfacing is daunting, either for patients or physicians involved,” he said in an interview.
The researchers reported having no relevant disclosures. Dr. Richer disclosed that he performs clinical trials for AbbVie/Allergan, Galderma, Leo Pharma, Pfizer, and is a member of advisory board for Bausch, Celgene, Eli Lilly, Galderma, Janssen, Johnson & Johnson, Leo Pharma, L’Oréal, and Sanofi. He is also a consultant to AbbVie/Allergan, Bausch, Celgene, Eli Lilly, Galderma, Janssen, Johnson & Johnson, Leo Pharma, L’Oréal, Merz, and Sanofi.
DENVER –
Rhinophyma occurs primarily in the sixth and seventh decades of life and is marked by facial hypertrophy that leads to tumor-like growth, inflammation, fibrosis, and loss of the cosmetic nasal subunits. “When it becomes severe it leads to a degree of embarrassment as well,” one of the study authors, Patricia Richey, MD, said during an oral abstract session at the annual meeting of the American Society for Dermatologic Surgery. “We found that our method has been efficacious, but most often, and more importantly, leads to an improvement in the patient’s quality of life.”
To date, clinicians have used fully ablative lasers to treat varying degrees of rhinophyma but at a cost of prolonged healing time and higher rates of scarring and pigment or textural changes. However, not all dermatologists use full-field ablative lasers in their practices.
“Fractionated ablative lasers have been used in the past for mild to moderate rhinophyma, but they cannot ablate to 100% density, which would be necessary to debulk the marked hypertrophy present in our patients,” said Dr. Richey, who practices Mohs surgery and cosmetic dermatology in Washington, D.C., and conducts research for the Wellman Center for Photomedicine and the Dermatology Laser and Cosmetic Center at Massachusetts General Hospital, Boston. “That’s why we added a surgical component.”
She and colleague Mathew M. Avram, MD, JD, developed a three-step method for treating severe rhinophyma that they performed on three elderly patients. Step 1 is the surgical debulk. Following infiltration of local anesthesia, a razor blade or 15-blade is used to excise the most prominent lobules of hypertrophied sebaceous tissue down to the fibrofatty layer of the nose as a partial thickness excision that does not reach the level of the perichondrium or cartilage. “Hemostasis is achieved with electrocoagulation and application of petrolatum ointment, followed by a pressure dressing,” Dr. Richey said. “The location of the debulk varies by patient.”
Step 2 involves fractionated ablative laser treatment 4 weeks later with either the CO2 or erbium:YAG (Er:YAG) 2,940-nm laser. According to Dr. Richey, the typical setting for the fractionated CO2 is a fluence of 70mJ/cm2 and a high density, performing six out of four passes with 60 seconds between each pass, “though these settings may vary based on the patient presentation,” she said.
The treatment level ranges from 5 (14% density) to 10 (70% density, for the most severe cases). Meanwhile, a representative setting for the ablative fractionated Er:YAG 2,940-nm laser is 250 mcm, no coagulation, 5.5% density, and one pass. “If a second surgical debulk is performed on the same day as ablative laser treatment, the sites of shave removal are typically avoided with the laser,” she said. If a certain portion of the nose has recently healed following surgical debulk 4 weeks prior, they may perform only two passes in this region.
In an interview, Dr. Avram, who directs the MGH Dermatology Laser and Cosmetic Center, characterized the staged method as providing “transformative change to severe, cosmetically disfiguring rhinophyma. The ablative fractional laser provides more fine-tuned contouring.”
The three patients studied had an average of three to four monthly treatments. “There is typically a great deal of improvement by the second treatment,” Dr. Richey said. Add-on treatments may include low voltage electrodessication at 1.8 watts for patients with well-demarcated papules of sebaceous hyperplasia, and a vascular laser such as the pulsed dye laser if telangiectasias are present.
One limitation of the stepwise method, she said, is that the surgical debulk typically results in a scar, “but it’s rarely noticeable if carefully performed, likely due to fractionated ablative use during the scar remodeling period. It’s important to set expectations with your patient at the initial consult. We always discuss treatment goals and that while we aim achieve the most desirable outcome possible, we’re never going to get them back to having a completely normal nose. They’re always going to have some mild or moderate rhinophymatous changes present.”
Vincent Richer, MD, a Vancouver-based medical and cosmetic dermatologist who was asked to comment on these results, characterized the stepwise method as promising. “Though more treatments are required, the easier recovery, safe outcomes in the case presented and excellent cosmetic result made it an interesting alternative when fully ablative resurfacing is daunting, either for patients or physicians involved,” he said in an interview.
The researchers reported having no relevant disclosures. Dr. Richer disclosed that he performs clinical trials for AbbVie/Allergan, Galderma, Leo Pharma, Pfizer, and is a member of advisory board for Bausch, Celgene, Eli Lilly, Galderma, Janssen, Johnson & Johnson, Leo Pharma, L’Oréal, and Sanofi. He is also a consultant to AbbVie/Allergan, Bausch, Celgene, Eli Lilly, Galderma, Janssen, Johnson & Johnson, Leo Pharma, L’Oréal, Merz, and Sanofi.
DENVER –
Rhinophyma occurs primarily in the sixth and seventh decades of life and is marked by facial hypertrophy that leads to tumor-like growth, inflammation, fibrosis, and loss of the cosmetic nasal subunits. “When it becomes severe it leads to a degree of embarrassment as well,” one of the study authors, Patricia Richey, MD, said during an oral abstract session at the annual meeting of the American Society for Dermatologic Surgery. “We found that our method has been efficacious, but most often, and more importantly, leads to an improvement in the patient’s quality of life.”
To date, clinicians have used fully ablative lasers to treat varying degrees of rhinophyma but at a cost of prolonged healing time and higher rates of scarring and pigment or textural changes. However, not all dermatologists use full-field ablative lasers in their practices.
“Fractionated ablative lasers have been used in the past for mild to moderate rhinophyma, but they cannot ablate to 100% density, which would be necessary to debulk the marked hypertrophy present in our patients,” said Dr. Richey, who practices Mohs surgery and cosmetic dermatology in Washington, D.C., and conducts research for the Wellman Center for Photomedicine and the Dermatology Laser and Cosmetic Center at Massachusetts General Hospital, Boston. “That’s why we added a surgical component.”
She and colleague Mathew M. Avram, MD, JD, developed a three-step method for treating severe rhinophyma that they performed on three elderly patients. Step 1 is the surgical debulk. Following infiltration of local anesthesia, a razor blade or 15-blade is used to excise the most prominent lobules of hypertrophied sebaceous tissue down to the fibrofatty layer of the nose as a partial thickness excision that does not reach the level of the perichondrium or cartilage. “Hemostasis is achieved with electrocoagulation and application of petrolatum ointment, followed by a pressure dressing,” Dr. Richey said. “The location of the debulk varies by patient.”
Step 2 involves fractionated ablative laser treatment 4 weeks later with either the CO2 or erbium:YAG (Er:YAG) 2,940-nm laser. According to Dr. Richey, the typical setting for the fractionated CO2 is a fluence of 70mJ/cm2 and a high density, performing six out of four passes with 60 seconds between each pass, “though these settings may vary based on the patient presentation,” she said.
The treatment level ranges from 5 (14% density) to 10 (70% density, for the most severe cases). Meanwhile, a representative setting for the ablative fractionated Er:YAG 2,940-nm laser is 250 mcm, no coagulation, 5.5% density, and one pass. “If a second surgical debulk is performed on the same day as ablative laser treatment, the sites of shave removal are typically avoided with the laser,” she said. If a certain portion of the nose has recently healed following surgical debulk 4 weeks prior, they may perform only two passes in this region.
In an interview, Dr. Avram, who directs the MGH Dermatology Laser and Cosmetic Center, characterized the staged method as providing “transformative change to severe, cosmetically disfiguring rhinophyma. The ablative fractional laser provides more fine-tuned contouring.”
The three patients studied had an average of three to four monthly treatments. “There is typically a great deal of improvement by the second treatment,” Dr. Richey said. Add-on treatments may include low voltage electrodessication at 1.8 watts for patients with well-demarcated papules of sebaceous hyperplasia, and a vascular laser such as the pulsed dye laser if telangiectasias are present.
One limitation of the stepwise method, she said, is that the surgical debulk typically results in a scar, “but it’s rarely noticeable if carefully performed, likely due to fractionated ablative use during the scar remodeling period. It’s important to set expectations with your patient at the initial consult. We always discuss treatment goals and that while we aim achieve the most desirable outcome possible, we’re never going to get them back to having a completely normal nose. They’re always going to have some mild or moderate rhinophymatous changes present.”
Vincent Richer, MD, a Vancouver-based medical and cosmetic dermatologist who was asked to comment on these results, characterized the stepwise method as promising. “Though more treatments are required, the easier recovery, safe outcomes in the case presented and excellent cosmetic result made it an interesting alternative when fully ablative resurfacing is daunting, either for patients or physicians involved,” he said in an interview.
The researchers reported having no relevant disclosures. Dr. Richer disclosed that he performs clinical trials for AbbVie/Allergan, Galderma, Leo Pharma, Pfizer, and is a member of advisory board for Bausch, Celgene, Eli Lilly, Galderma, Janssen, Johnson & Johnson, Leo Pharma, L’Oréal, and Sanofi. He is also a consultant to AbbVie/Allergan, Bausch, Celgene, Eli Lilly, Galderma, Janssen, Johnson & Johnson, Leo Pharma, L’Oréal, Merz, and Sanofi.
AT ASDS 2022
Expert makes the case for not subtyping patients with rosacea
. At least they should be, according to
“How many people with papules and pustules don’t also have redness?” Dr. Harper, who practices in Birmingham, Ala., said at Medscape Live’s annual Coastal Dermatology Symposium. “If we’re not careful, and we try to classify a person into a subtype of rosacea, we end up treating only part of their rosacea; we don’t treat all of it. We have seen this in the literature,” she added.
“The idea now is to take a phenotypic approach to rosacea. What we mean by that is that you look at the patient, you document every part of rosacea that you see, and you treat according to that,” she continued. “That person with papules and pustules may also have phyma and ocular disease. They may have telangiectasia and persistent background erythema. They may also have flushing.”
Dr. Harper incorporates the mnemonic “STOP” to her visits with rosacea patients.
S stands for: Identify signs and symptoms of the condition. “Listen to the patient for symptoms,” she advised. “We’ve learned to listen to darker skinned patients for what they tell us about erythema, for example, because we may not be able to see it, yet they are experiencing it. They may also have symptomatic burning, itching, and stinging.”
T stands for: Discuss triggers. “Ask patients, ‘what is it that makes your rosacea worse?’ That’s different for everyone,” she said.
O stands for: Agree on a treatment outcome. “Ask, ‘what is it that really bothers you? Are you bothered by the bumps? The redness?’ ” she said.
“The P stands for: Develop a plan that addresses all of that,” she said.
Different treatments for different rosacea symptoms
No one-size-fits-all treatment exists for rosacea. Options that work well for papules and pustules aren’t effective for redness. Similarly, products that work for redness don’t work for telangiectasia.
“Different lesions and signs of rosacea will likely require multiple modes of treatment,” Dr. Harper said. “So, when you evaluate your rosacea patients, if they’re doing great, don’t change their regimen. But if you see somebody who is not well controlled, is there an opportunity for you to come in and add something to that regimen that may make them better? Maybe so.”
Treatment options indicated for papules and pustules include ivermectin, metronidazole, azelaic acid, sodium sulfacetamide/sulfur, modified release doxycycline, minocycline foam, and encapsulated benzoyl peroxide.
Options indicated for persistent background erythema include brimonidine and oxymetazoline, while device-based treatments include the pulsed dye laser, the KTP laser, intense pulsed light, and electrosurgery.
Anti-inflammatory action for pustules and papules
A relatively new product indicated for pustules and papules is minocycline 1.5% foam, the only minocycline that is FDA approved to treat rosacea.
“There is no oral minocycline product approved for rosacea yet,” Dr. Harper said. “There is not a known bacterial pathogen in rosacea. Tetracyclines likely work in rosacea by inhibiting neutrophil chemotaxis, inhibiting MMP and thus KLK-5 and LL-37, inhibiting pro-inflammatory cytokines, downregulating reactive oxygen species, and inhibiting angiogenesis.”
In two 12-week, phase 3 randomized studies of 1,522 patients with moderate to severe rosacea, participants were assigned to receive minocycline 5% foam or a vehicle that contained mineral oil and coconut oil.
At week 12, about 50% of patients who received minocycline 5% foam were clear, compared with about 40% of those in the vehicle arm. Also, the reduction of lesion count was about 63% for patients in the treatment group, compared with a reduction of about 54% in the vehicle arm.
Dr. Harper characterized the 63% reduction as “pretty good, but is it good enough or fast enough? I don’t think so, so even with a great drug like this, I would use something else. You can use two medications sometimes to get people better faster. There’s room to bring in something for that background erythema.”
Minocycline 1.5% foam is colored yellow and may stain fabric. “It contains coconut oil, soybean oil, and light mineral oil,” she said. “Most people prefer to use this at bedtime, but you don’t have to.”
Another treatment option is 5% microencapsulated benzoyl peroxide cream, which is FDA approved for inflammatory lesions of rosacea.
“What’s the mechanism of action? Probably not being antimicrobial,” Dr. Harper said. “I think it’s probably at least in part anti-inflammatory, because we have some data to show that it’s killing Demodex [mites]. If Demodex [are] a trigger of inflammation, and we can lessen Demodex, then we could lessen the inflammatory response after that.”
The drug’s approval was based on data from two positive, identical phase 3 randomized, double-blind, multicenter, 12-week clinical trials that evaluated its safety compared with vehicle in 733 people with inflammatory lesions of rosacea (NCT03564119 and NCT03448939).
At week 12, inflammatory lesions of rosacea were reduced by nearly 70% in both trials among those who received 5% microencapsulated benzoyl peroxide cream, compared with 38%-46% among those who received the vehicle. Also, nearly 50% of subjects in the treatment groups were clear or almost clear at 12 weeks, compared with 38%-46% of those who received the vehicle.
Dr. Harper added that about one-quarter of patients in the treatment group of the trials were clear or almost clear by week 4. “That’s pretty fast,” she said, noting that the product’s microencapsulated shell acts as a fenestrated barrier. “It has little openings, which means that it takes a while for the drug to work itself out,” she said. “I think of it as being like a speed bump for benzoyl peroxide delivery. It has to get through this little maze before it lands on the skin. We think that is what has helped with tolerability.”
Oral sarecycline, a narrow spectrum tetracycline that was FDA approved for acne in 2018, may also benefit rosacea patients. In a 12-week, investigator-blinded pilot study, 72 patients with papulopustular rosacea were assigned to receive sarecycline, while 25 received a multivitamin.
By week 12, 75% of patients in the sarecycline group were clear, compared with 16% of those in the multivitamin group, while the inflammatory lesion counts dropped from baseline by 80% and 60%, respectively. Studies of sarecycline for acne have demonstrated similar rates of vertigo, dizziness, and sunburn to those of placebo.
“There were also low rates of gastrointestinal disturbances,” Dr. Harper said. “That’s important in rosacea, because there is no bacterial pathogen.”
Dr. Harper disclosed that she serves as an advisor or consultant for Almirall, BioPharmX, Cassiopeia, Cutanea, Cutera, Dermira, EPI, Galderma, LaRoche-Posay, Ortho, Vyne, Sol Gel, and Sun. She also serves as a speaker or member of a speakers bureau for Almirall, EPI, Galderma, Ortho, and Vyne.
Medscape Live and this news organization are owned by the same parent company.
. At least they should be, according to
“How many people with papules and pustules don’t also have redness?” Dr. Harper, who practices in Birmingham, Ala., said at Medscape Live’s annual Coastal Dermatology Symposium. “If we’re not careful, and we try to classify a person into a subtype of rosacea, we end up treating only part of their rosacea; we don’t treat all of it. We have seen this in the literature,” she added.
“The idea now is to take a phenotypic approach to rosacea. What we mean by that is that you look at the patient, you document every part of rosacea that you see, and you treat according to that,” she continued. “That person with papules and pustules may also have phyma and ocular disease. They may have telangiectasia and persistent background erythema. They may also have flushing.”
Dr. Harper incorporates the mnemonic “STOP” to her visits with rosacea patients.
S stands for: Identify signs and symptoms of the condition. “Listen to the patient for symptoms,” she advised. “We’ve learned to listen to darker skinned patients for what they tell us about erythema, for example, because we may not be able to see it, yet they are experiencing it. They may also have symptomatic burning, itching, and stinging.”
T stands for: Discuss triggers. “Ask patients, ‘what is it that makes your rosacea worse?’ That’s different for everyone,” she said.
O stands for: Agree on a treatment outcome. “Ask, ‘what is it that really bothers you? Are you bothered by the bumps? The redness?’ ” she said.
“The P stands for: Develop a plan that addresses all of that,” she said.
Different treatments for different rosacea symptoms
No one-size-fits-all treatment exists for rosacea. Options that work well for papules and pustules aren’t effective for redness. Similarly, products that work for redness don’t work for telangiectasia.
“Different lesions and signs of rosacea will likely require multiple modes of treatment,” Dr. Harper said. “So, when you evaluate your rosacea patients, if they’re doing great, don’t change their regimen. But if you see somebody who is not well controlled, is there an opportunity for you to come in and add something to that regimen that may make them better? Maybe so.”
Treatment options indicated for papules and pustules include ivermectin, metronidazole, azelaic acid, sodium sulfacetamide/sulfur, modified release doxycycline, minocycline foam, and encapsulated benzoyl peroxide.
Options indicated for persistent background erythema include brimonidine and oxymetazoline, while device-based treatments include the pulsed dye laser, the KTP laser, intense pulsed light, and electrosurgery.
Anti-inflammatory action for pustules and papules
A relatively new product indicated for pustules and papules is minocycline 1.5% foam, the only minocycline that is FDA approved to treat rosacea.
“There is no oral minocycline product approved for rosacea yet,” Dr. Harper said. “There is not a known bacterial pathogen in rosacea. Tetracyclines likely work in rosacea by inhibiting neutrophil chemotaxis, inhibiting MMP and thus KLK-5 and LL-37, inhibiting pro-inflammatory cytokines, downregulating reactive oxygen species, and inhibiting angiogenesis.”
In two 12-week, phase 3 randomized studies of 1,522 patients with moderate to severe rosacea, participants were assigned to receive minocycline 5% foam or a vehicle that contained mineral oil and coconut oil.
At week 12, about 50% of patients who received minocycline 5% foam were clear, compared with about 40% of those in the vehicle arm. Also, the reduction of lesion count was about 63% for patients in the treatment group, compared with a reduction of about 54% in the vehicle arm.
Dr. Harper characterized the 63% reduction as “pretty good, but is it good enough or fast enough? I don’t think so, so even with a great drug like this, I would use something else. You can use two medications sometimes to get people better faster. There’s room to bring in something for that background erythema.”
Minocycline 1.5% foam is colored yellow and may stain fabric. “It contains coconut oil, soybean oil, and light mineral oil,” she said. “Most people prefer to use this at bedtime, but you don’t have to.”
Another treatment option is 5% microencapsulated benzoyl peroxide cream, which is FDA approved for inflammatory lesions of rosacea.
“What’s the mechanism of action? Probably not being antimicrobial,” Dr. Harper said. “I think it’s probably at least in part anti-inflammatory, because we have some data to show that it’s killing Demodex [mites]. If Demodex [are] a trigger of inflammation, and we can lessen Demodex, then we could lessen the inflammatory response after that.”
The drug’s approval was based on data from two positive, identical phase 3 randomized, double-blind, multicenter, 12-week clinical trials that evaluated its safety compared with vehicle in 733 people with inflammatory lesions of rosacea (NCT03564119 and NCT03448939).
At week 12, inflammatory lesions of rosacea were reduced by nearly 70% in both trials among those who received 5% microencapsulated benzoyl peroxide cream, compared with 38%-46% among those who received the vehicle. Also, nearly 50% of subjects in the treatment groups were clear or almost clear at 12 weeks, compared with 38%-46% of those who received the vehicle.
Dr. Harper added that about one-quarter of patients in the treatment group of the trials were clear or almost clear by week 4. “That’s pretty fast,” she said, noting that the product’s microencapsulated shell acts as a fenestrated barrier. “It has little openings, which means that it takes a while for the drug to work itself out,” she said. “I think of it as being like a speed bump for benzoyl peroxide delivery. It has to get through this little maze before it lands on the skin. We think that is what has helped with tolerability.”
Oral sarecycline, a narrow spectrum tetracycline that was FDA approved for acne in 2018, may also benefit rosacea patients. In a 12-week, investigator-blinded pilot study, 72 patients with papulopustular rosacea were assigned to receive sarecycline, while 25 received a multivitamin.
By week 12, 75% of patients in the sarecycline group were clear, compared with 16% of those in the multivitamin group, while the inflammatory lesion counts dropped from baseline by 80% and 60%, respectively. Studies of sarecycline for acne have demonstrated similar rates of vertigo, dizziness, and sunburn to those of placebo.
“There were also low rates of gastrointestinal disturbances,” Dr. Harper said. “That’s important in rosacea, because there is no bacterial pathogen.”
Dr. Harper disclosed that she serves as an advisor or consultant for Almirall, BioPharmX, Cassiopeia, Cutanea, Cutera, Dermira, EPI, Galderma, LaRoche-Posay, Ortho, Vyne, Sol Gel, and Sun. She also serves as a speaker or member of a speakers bureau for Almirall, EPI, Galderma, Ortho, and Vyne.
Medscape Live and this news organization are owned by the same parent company.
. At least they should be, according to
“How many people with papules and pustules don’t also have redness?” Dr. Harper, who practices in Birmingham, Ala., said at Medscape Live’s annual Coastal Dermatology Symposium. “If we’re not careful, and we try to classify a person into a subtype of rosacea, we end up treating only part of their rosacea; we don’t treat all of it. We have seen this in the literature,” she added.
“The idea now is to take a phenotypic approach to rosacea. What we mean by that is that you look at the patient, you document every part of rosacea that you see, and you treat according to that,” she continued. “That person with papules and pustules may also have phyma and ocular disease. They may have telangiectasia and persistent background erythema. They may also have flushing.”
Dr. Harper incorporates the mnemonic “STOP” to her visits with rosacea patients.
S stands for: Identify signs and symptoms of the condition. “Listen to the patient for symptoms,” she advised. “We’ve learned to listen to darker skinned patients for what they tell us about erythema, for example, because we may not be able to see it, yet they are experiencing it. They may also have symptomatic burning, itching, and stinging.”
T stands for: Discuss triggers. “Ask patients, ‘what is it that makes your rosacea worse?’ That’s different for everyone,” she said.
O stands for: Agree on a treatment outcome. “Ask, ‘what is it that really bothers you? Are you bothered by the bumps? The redness?’ ” she said.
“The P stands for: Develop a plan that addresses all of that,” she said.
Different treatments for different rosacea symptoms
No one-size-fits-all treatment exists for rosacea. Options that work well for papules and pustules aren’t effective for redness. Similarly, products that work for redness don’t work for telangiectasia.
“Different lesions and signs of rosacea will likely require multiple modes of treatment,” Dr. Harper said. “So, when you evaluate your rosacea patients, if they’re doing great, don’t change their regimen. But if you see somebody who is not well controlled, is there an opportunity for you to come in and add something to that regimen that may make them better? Maybe so.”
Treatment options indicated for papules and pustules include ivermectin, metronidazole, azelaic acid, sodium sulfacetamide/sulfur, modified release doxycycline, minocycline foam, and encapsulated benzoyl peroxide.
Options indicated for persistent background erythema include brimonidine and oxymetazoline, while device-based treatments include the pulsed dye laser, the KTP laser, intense pulsed light, and electrosurgery.
Anti-inflammatory action for pustules and papules
A relatively new product indicated for pustules and papules is minocycline 1.5% foam, the only minocycline that is FDA approved to treat rosacea.
“There is no oral minocycline product approved for rosacea yet,” Dr. Harper said. “There is not a known bacterial pathogen in rosacea. Tetracyclines likely work in rosacea by inhibiting neutrophil chemotaxis, inhibiting MMP and thus KLK-5 and LL-37, inhibiting pro-inflammatory cytokines, downregulating reactive oxygen species, and inhibiting angiogenesis.”
In two 12-week, phase 3 randomized studies of 1,522 patients with moderate to severe rosacea, participants were assigned to receive minocycline 5% foam or a vehicle that contained mineral oil and coconut oil.
At week 12, about 50% of patients who received minocycline 5% foam were clear, compared with about 40% of those in the vehicle arm. Also, the reduction of lesion count was about 63% for patients in the treatment group, compared with a reduction of about 54% in the vehicle arm.
Dr. Harper characterized the 63% reduction as “pretty good, but is it good enough or fast enough? I don’t think so, so even with a great drug like this, I would use something else. You can use two medications sometimes to get people better faster. There’s room to bring in something for that background erythema.”
Minocycline 1.5% foam is colored yellow and may stain fabric. “It contains coconut oil, soybean oil, and light mineral oil,” she said. “Most people prefer to use this at bedtime, but you don’t have to.”
Another treatment option is 5% microencapsulated benzoyl peroxide cream, which is FDA approved for inflammatory lesions of rosacea.
“What’s the mechanism of action? Probably not being antimicrobial,” Dr. Harper said. “I think it’s probably at least in part anti-inflammatory, because we have some data to show that it’s killing Demodex [mites]. If Demodex [are] a trigger of inflammation, and we can lessen Demodex, then we could lessen the inflammatory response after that.”
The drug’s approval was based on data from two positive, identical phase 3 randomized, double-blind, multicenter, 12-week clinical trials that evaluated its safety compared with vehicle in 733 people with inflammatory lesions of rosacea (NCT03564119 and NCT03448939).
At week 12, inflammatory lesions of rosacea were reduced by nearly 70% in both trials among those who received 5% microencapsulated benzoyl peroxide cream, compared with 38%-46% among those who received the vehicle. Also, nearly 50% of subjects in the treatment groups were clear or almost clear at 12 weeks, compared with 38%-46% of those who received the vehicle.
Dr. Harper added that about one-quarter of patients in the treatment group of the trials were clear or almost clear by week 4. “That’s pretty fast,” she said, noting that the product’s microencapsulated shell acts as a fenestrated barrier. “It has little openings, which means that it takes a while for the drug to work itself out,” she said. “I think of it as being like a speed bump for benzoyl peroxide delivery. It has to get through this little maze before it lands on the skin. We think that is what has helped with tolerability.”
Oral sarecycline, a narrow spectrum tetracycline that was FDA approved for acne in 2018, may also benefit rosacea patients. In a 12-week, investigator-blinded pilot study, 72 patients with papulopustular rosacea were assigned to receive sarecycline, while 25 received a multivitamin.
By week 12, 75% of patients in the sarecycline group were clear, compared with 16% of those in the multivitamin group, while the inflammatory lesion counts dropped from baseline by 80% and 60%, respectively. Studies of sarecycline for acne have demonstrated similar rates of vertigo, dizziness, and sunburn to those of placebo.
“There were also low rates of gastrointestinal disturbances,” Dr. Harper said. “That’s important in rosacea, because there is no bacterial pathogen.”
Dr. Harper disclosed that she serves as an advisor or consultant for Almirall, BioPharmX, Cassiopeia, Cutanea, Cutera, Dermira, EPI, Galderma, LaRoche-Posay, Ortho, Vyne, Sol Gel, and Sun. She also serves as a speaker or member of a speakers bureau for Almirall, EPI, Galderma, Ortho, and Vyne.
Medscape Live and this news organization are owned by the same parent company.
FROM MEDSCAPE LIVE COASTAL DERM