Doug Brunk is a San Diego-based award-winning reporter who began covering health care in 1991. Before joining the company, he wrote for the health sciences division of Columbia University and was an associate editor at Contemporary Long Term Care magazine when it won a Jesse H. Neal Award. His work has been syndicated by the Los Angeles Times and he is the author of two books related to the University of Kentucky Wildcats men's basketball program. Doug has a master’s degree in magazine journalism from the S.I. Newhouse School of Public Communications at Syracuse University. Follow him on Twitter @dougbrunk.

When treating scars, ‘rehabilitation’ is the goal, not perfection

Article Type
Changed
Mon, 09/18/2023 - 07:46

Injecting a scar with intralesional steroids is a popular way to reduce its size and soften the surrounding tissue, but proper technique matters, according to Victor Ross, MD.

“A lot of lip service is paid to how to inject the steroid,” Dr. Ross, director of laser and cosmetic dermatology at the Scripps Clinic in San Diego, said at the annual Masters of Aesthetics Symposium. “The most important part is the amount and the fastidiousness that you have injecting. You should see the tip of the needle and be very slow. Use a 1 cc syringe.” He used to inject scars with triamcinolone acetate 40 mg/mL, but now he almost always injects 10-20 mg/mL to avoid inducing white streak-like atrophy or hypopigmentation around the treated area.

“When you treat a scar, you treat the features of the scar that make it stand out,” Dr. Ross continued. “If it’s red, you address the hyperemia. If it’s brown, you address the pigment. You want to have a reasonable pathophysiological basis for what you’re doing. Understand how the scar got there and have a reasonable algorithm.” When he counsels patients about clinical outcomes to expect, he emphasizes rehabilitation instead of blemish-free perfection. “It’s not making the scar go away,” he said. “It’s not restoring completely normal skin form and function; it’s a restorative effort to get toward normality. That’s what it’s all about.”



Besides injecting scars with triamcinolone acetate, other scar treatment options include intralesional 5-fluorouracil, oral antihistamines, COX-2 inhibitors, hydrogel sheeting, compression, acoustic wave therapy, photodynamic therapy, radiofrequency, and lasers. “I’m not a big fan of low-level light; it probably does something [to scars], but I’m skeptical,” Dr. Ross said.

In his clinical opinion, most scars respond best to treatments with ablative and nonablative fractional lasers tuned to gentle settings such as an energy level of 20 millijoules at a density of 5%-10%. “Every scar deserves a chance for laser remediation and rehabilitation,” he said. “With radiation scars you want to be particularly gentle. If you have a Mohs scar that has been subsequently treated with radiation, I would lower my settings by half, because I’ve had some scars worsen with settings for red scars after radiation therapy.”

He often uses fractional lasers for stubborn acne scarring. “The hyperemic component you can treat with a vascular laser, then come back [and treat the scarring] with a nonablative fractional laser, or you could use radiofrequency microneedling as well,” Dr. Ross said.

New or innovative scar treatments coming down the pike, he said, include the following: mitomycin C (applied topically, he said that this has worked well for postoperative keloids), tamoxifen, oral methotrexate, imiquimod (which has mixed results to date), platelet-rich plasma, and retinoids.

Dr. Ross disclosed having research and financial ties to numerous pharmaceutical and device companies.

Meeting/Event
Publications
Topics
Sections
Meeting/Event
Meeting/Event

Injecting a scar with intralesional steroids is a popular way to reduce its size and soften the surrounding tissue, but proper technique matters, according to Victor Ross, MD.

“A lot of lip service is paid to how to inject the steroid,” Dr. Ross, director of laser and cosmetic dermatology at the Scripps Clinic in San Diego, said at the annual Masters of Aesthetics Symposium. “The most important part is the amount and the fastidiousness that you have injecting. You should see the tip of the needle and be very slow. Use a 1 cc syringe.” He used to inject scars with triamcinolone acetate 40 mg/mL, but now he almost always injects 10-20 mg/mL to avoid inducing white streak-like atrophy or hypopigmentation around the treated area.

“When you treat a scar, you treat the features of the scar that make it stand out,” Dr. Ross continued. “If it’s red, you address the hyperemia. If it’s brown, you address the pigment. You want to have a reasonable pathophysiological basis for what you’re doing. Understand how the scar got there and have a reasonable algorithm.” When he counsels patients about clinical outcomes to expect, he emphasizes rehabilitation instead of blemish-free perfection. “It’s not making the scar go away,” he said. “It’s not restoring completely normal skin form and function; it’s a restorative effort to get toward normality. That’s what it’s all about.”



Besides injecting scars with triamcinolone acetate, other scar treatment options include intralesional 5-fluorouracil, oral antihistamines, COX-2 inhibitors, hydrogel sheeting, compression, acoustic wave therapy, photodynamic therapy, radiofrequency, and lasers. “I’m not a big fan of low-level light; it probably does something [to scars], but I’m skeptical,” Dr. Ross said.

In his clinical opinion, most scars respond best to treatments with ablative and nonablative fractional lasers tuned to gentle settings such as an energy level of 20 millijoules at a density of 5%-10%. “Every scar deserves a chance for laser remediation and rehabilitation,” he said. “With radiation scars you want to be particularly gentle. If you have a Mohs scar that has been subsequently treated with radiation, I would lower my settings by half, because I’ve had some scars worsen with settings for red scars after radiation therapy.”

He often uses fractional lasers for stubborn acne scarring. “The hyperemic component you can treat with a vascular laser, then come back [and treat the scarring] with a nonablative fractional laser, or you could use radiofrequency microneedling as well,” Dr. Ross said.

New or innovative scar treatments coming down the pike, he said, include the following: mitomycin C (applied topically, he said that this has worked well for postoperative keloids), tamoxifen, oral methotrexate, imiquimod (which has mixed results to date), platelet-rich plasma, and retinoids.

Dr. Ross disclosed having research and financial ties to numerous pharmaceutical and device companies.

Injecting a scar with intralesional steroids is a popular way to reduce its size and soften the surrounding tissue, but proper technique matters, according to Victor Ross, MD.

“A lot of lip service is paid to how to inject the steroid,” Dr. Ross, director of laser and cosmetic dermatology at the Scripps Clinic in San Diego, said at the annual Masters of Aesthetics Symposium. “The most important part is the amount and the fastidiousness that you have injecting. You should see the tip of the needle and be very slow. Use a 1 cc syringe.” He used to inject scars with triamcinolone acetate 40 mg/mL, but now he almost always injects 10-20 mg/mL to avoid inducing white streak-like atrophy or hypopigmentation around the treated area.

“When you treat a scar, you treat the features of the scar that make it stand out,” Dr. Ross continued. “If it’s red, you address the hyperemia. If it’s brown, you address the pigment. You want to have a reasonable pathophysiological basis for what you’re doing. Understand how the scar got there and have a reasonable algorithm.” When he counsels patients about clinical outcomes to expect, he emphasizes rehabilitation instead of blemish-free perfection. “It’s not making the scar go away,” he said. “It’s not restoring completely normal skin form and function; it’s a restorative effort to get toward normality. That’s what it’s all about.”



Besides injecting scars with triamcinolone acetate, other scar treatment options include intralesional 5-fluorouracil, oral antihistamines, COX-2 inhibitors, hydrogel sheeting, compression, acoustic wave therapy, photodynamic therapy, radiofrequency, and lasers. “I’m not a big fan of low-level light; it probably does something [to scars], but I’m skeptical,” Dr. Ross said.

In his clinical opinion, most scars respond best to treatments with ablative and nonablative fractional lasers tuned to gentle settings such as an energy level of 20 millijoules at a density of 5%-10%. “Every scar deserves a chance for laser remediation and rehabilitation,” he said. “With radiation scars you want to be particularly gentle. If you have a Mohs scar that has been subsequently treated with radiation, I would lower my settings by half, because I’ve had some scars worsen with settings for red scars after radiation therapy.”

He often uses fractional lasers for stubborn acne scarring. “The hyperemic component you can treat with a vascular laser, then come back [and treat the scarring] with a nonablative fractional laser, or you could use radiofrequency microneedling as well,” Dr. Ross said.

New or innovative scar treatments coming down the pike, he said, include the following: mitomycin C (applied topically, he said that this has worked well for postoperative keloids), tamoxifen, oral methotrexate, imiquimod (which has mixed results to date), platelet-rich plasma, and retinoids.

Dr. Ross disclosed having research and financial ties to numerous pharmaceutical and device companies.

Publications
Publications
Topics
Article Type
Sections
Article Source

FROM MOAS 2023

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

CHMP recommends marketing of biologic for atopic dermatitis

Article Type
Changed
Fri, 09/15/2023 - 14:45

 

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization of lebrikizumab for the treatment of adult and adolescent patients with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.

Lebrikizumab is an investigational, monoclonal antibody that binds to cytokine interleukin (IL)-13, which has been implicated in driving the type-2 inflammatory loop in the skin, leading to skin barrier dysfunction, itch, skin thickening, and infection. The biologic is being developed by Almirall and is designed to be administered once per month. Lebrikizumab is not yet available in the United States.



According to a press release from Almirall, the CHMP opinion was based on three pivotal phase 3 studies that showed long-term response in skin clearance and itch control. ADvocate 1 and ADvocate 2 evaluated lebrikizumab as monotherapy, while ADhere assessed lebrikizumab in combination with topical corticosteroids (TCS) in adult and adolescent patients with moderate to severe AD. At week 16, more than 50% of patients with moderate to severe AD experienced at least a 75% reduction in disease severity (EASI-75) when receiving lebrikizumab monotherapy in the ADvocate studies and nearly 70% of patients receiving lebrikizumab combined with standard-of-care TCS achieved EASI-75 in the ADhere trial.

Most adverse events across the studies were mild or moderate. The most common reactions were conjunctivitis, injection site reactions, allergic conjunctivitis, and dry eye.

Publications
Topics
Sections

 

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization of lebrikizumab for the treatment of adult and adolescent patients with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.

Lebrikizumab is an investigational, monoclonal antibody that binds to cytokine interleukin (IL)-13, which has been implicated in driving the type-2 inflammatory loop in the skin, leading to skin barrier dysfunction, itch, skin thickening, and infection. The biologic is being developed by Almirall and is designed to be administered once per month. Lebrikizumab is not yet available in the United States.



According to a press release from Almirall, the CHMP opinion was based on three pivotal phase 3 studies that showed long-term response in skin clearance and itch control. ADvocate 1 and ADvocate 2 evaluated lebrikizumab as monotherapy, while ADhere assessed lebrikizumab in combination with topical corticosteroids (TCS) in adult and adolescent patients with moderate to severe AD. At week 16, more than 50% of patients with moderate to severe AD experienced at least a 75% reduction in disease severity (EASI-75) when receiving lebrikizumab monotherapy in the ADvocate studies and nearly 70% of patients receiving lebrikizumab combined with standard-of-care TCS achieved EASI-75 in the ADhere trial.

Most adverse events across the studies were mild or moderate. The most common reactions were conjunctivitis, injection site reactions, allergic conjunctivitis, and dry eye.

 

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization of lebrikizumab for the treatment of adult and adolescent patients with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.

Lebrikizumab is an investigational, monoclonal antibody that binds to cytokine interleukin (IL)-13, which has been implicated in driving the type-2 inflammatory loop in the skin, leading to skin barrier dysfunction, itch, skin thickening, and infection. The biologic is being developed by Almirall and is designed to be administered once per month. Lebrikizumab is not yet available in the United States.



According to a press release from Almirall, the CHMP opinion was based on three pivotal phase 3 studies that showed long-term response in skin clearance and itch control. ADvocate 1 and ADvocate 2 evaluated lebrikizumab as monotherapy, while ADhere assessed lebrikizumab in combination with topical corticosteroids (TCS) in adult and adolescent patients with moderate to severe AD. At week 16, more than 50% of patients with moderate to severe AD experienced at least a 75% reduction in disease severity (EASI-75) when receiving lebrikizumab monotherapy in the ADvocate studies and nearly 70% of patients receiving lebrikizumab combined with standard-of-care TCS achieved EASI-75 in the ADhere trial.

Most adverse events across the studies were mild or moderate. The most common reactions were conjunctivitis, injection site reactions, allergic conjunctivitis, and dry eye.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Hyperbaric oxygen therapy beneficial for calciphylaxis?

Article Type
Changed
Thu, 09/14/2023 - 15:34

Hyperbaric oxygen therapy (HBOT) may have a role in treating calciphylaxis, with benefits in both mortality and wound healing, report Daniela Kroshinsky, MD, MPH, of the department of dermatology at Massachusetts General Hospital, Boston, and colleagues.

Although intravenous sodium thiosulfate (IV STS) is considered standard care in the treatment of calciphylaxis, HBOT has been reported to have beneficial effects, they noted.

In their study, the researchers retrospectively reviewed records of 93 patients newly diagnosed with calciphylaxis, seen at Massachusetts General Hospital, between January 2006 and December 2021. They compared mortality and wound healing outcomes for 57 patients treated with IV STS only (control group) with those of 36 patients treated with HBOT plus IV STS (treatment group). Traditional survival analyses and Cox proportional hazard modeling were used to examine mortality data, and mixed effects modeling was used to analyze longitudinal wound outcomes. The study was published in the Journal of the American Academy of Dermatology.

Univariate survival analyses showed that HBOT plus IV STS was associated with significantly longer survival time than IV STS alone (P = .016), particularly for those with nonnephrogenic calciphylaxis (P < .0001), they report. An increased number of HBOT sessions conferred improved mortality outcomes, with 1, 5, 10, and 20 sessions yielding decreasing hazard ratios.



There was also a significant positive association between an increasing number of HBOT sessions and increased wound score (P = .042). Increases were seen with each session.

Anxiety/claustrophobia was the most common side effect reported among those in the HBOT group (22%).

“Given the proposed benefits and seemingly low side effect profile, it is the authors’ recommendation that HBOT be offered as an additional intervention to patients with calciphylaxis, especially if they have open wounds, to improve outcomes and expedite wound healing,” the researchers concluded.

Limitations, they noted, included the small sample size, retrospective design, and the potential for not adequately capturing patients who received external care. They were also unable to match patients by disease or wound severity. Large prospective trials would help clarify the role of HBOT for calciphylaxis, they added.

The researchers reported no relevant disclosures.

A version of this article first appeared on Medscape.com.

Publications
Topics
Sections

Hyperbaric oxygen therapy (HBOT) may have a role in treating calciphylaxis, with benefits in both mortality and wound healing, report Daniela Kroshinsky, MD, MPH, of the department of dermatology at Massachusetts General Hospital, Boston, and colleagues.

Although intravenous sodium thiosulfate (IV STS) is considered standard care in the treatment of calciphylaxis, HBOT has been reported to have beneficial effects, they noted.

In their study, the researchers retrospectively reviewed records of 93 patients newly diagnosed with calciphylaxis, seen at Massachusetts General Hospital, between January 2006 and December 2021. They compared mortality and wound healing outcomes for 57 patients treated with IV STS only (control group) with those of 36 patients treated with HBOT plus IV STS (treatment group). Traditional survival analyses and Cox proportional hazard modeling were used to examine mortality data, and mixed effects modeling was used to analyze longitudinal wound outcomes. The study was published in the Journal of the American Academy of Dermatology.

Univariate survival analyses showed that HBOT plus IV STS was associated with significantly longer survival time than IV STS alone (P = .016), particularly for those with nonnephrogenic calciphylaxis (P < .0001), they report. An increased number of HBOT sessions conferred improved mortality outcomes, with 1, 5, 10, and 20 sessions yielding decreasing hazard ratios.



There was also a significant positive association between an increasing number of HBOT sessions and increased wound score (P = .042). Increases were seen with each session.

Anxiety/claustrophobia was the most common side effect reported among those in the HBOT group (22%).

“Given the proposed benefits and seemingly low side effect profile, it is the authors’ recommendation that HBOT be offered as an additional intervention to patients with calciphylaxis, especially if they have open wounds, to improve outcomes and expedite wound healing,” the researchers concluded.

Limitations, they noted, included the small sample size, retrospective design, and the potential for not adequately capturing patients who received external care. They were also unable to match patients by disease or wound severity. Large prospective trials would help clarify the role of HBOT for calciphylaxis, they added.

The researchers reported no relevant disclosures.

A version of this article first appeared on Medscape.com.

Hyperbaric oxygen therapy (HBOT) may have a role in treating calciphylaxis, with benefits in both mortality and wound healing, report Daniela Kroshinsky, MD, MPH, of the department of dermatology at Massachusetts General Hospital, Boston, and colleagues.

Although intravenous sodium thiosulfate (IV STS) is considered standard care in the treatment of calciphylaxis, HBOT has been reported to have beneficial effects, they noted.

In their study, the researchers retrospectively reviewed records of 93 patients newly diagnosed with calciphylaxis, seen at Massachusetts General Hospital, between January 2006 and December 2021. They compared mortality and wound healing outcomes for 57 patients treated with IV STS only (control group) with those of 36 patients treated with HBOT plus IV STS (treatment group). Traditional survival analyses and Cox proportional hazard modeling were used to examine mortality data, and mixed effects modeling was used to analyze longitudinal wound outcomes. The study was published in the Journal of the American Academy of Dermatology.

Univariate survival analyses showed that HBOT plus IV STS was associated with significantly longer survival time than IV STS alone (P = .016), particularly for those with nonnephrogenic calciphylaxis (P < .0001), they report. An increased number of HBOT sessions conferred improved mortality outcomes, with 1, 5, 10, and 20 sessions yielding decreasing hazard ratios.



There was also a significant positive association between an increasing number of HBOT sessions and increased wound score (P = .042). Increases were seen with each session.

Anxiety/claustrophobia was the most common side effect reported among those in the HBOT group (22%).

“Given the proposed benefits and seemingly low side effect profile, it is the authors’ recommendation that HBOT be offered as an additional intervention to patients with calciphylaxis, especially if they have open wounds, to improve outcomes and expedite wound healing,” the researchers concluded.

Limitations, they noted, included the small sample size, retrospective design, and the potential for not adequately capturing patients who received external care. They were also unable to match patients by disease or wound severity. Large prospective trials would help clarify the role of HBOT for calciphylaxis, they added.

The researchers reported no relevant disclosures.

A version of this article first appeared on Medscape.com.

Publications
Publications
Topics
Article Type
Sections
Article Source

FROM THE JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Company submits supplemental NDA for topical atopic dermatitis treatment

Article Type
Changed
Tue, 10/03/2023 - 11:51

 

Arcutis Biotherapeutics has submitted a supplemental New Drug Application (sNDA) to the Food and Drug Administration for roflumilast cream 0.15% for the treatment of mild to moderate atopic dermatitis (AD) in adults and children aged 6 years and older.

Roflumilast cream 0.3% (Zoryve) is currently approved by the FDA for the topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older. Submission of the sNDA is based on positive results from the Interventional Trial Evaluating Roflumilast Cream for the Treatment of Atopic Dermatitis (INTEGUMENT-1 and INTEGUMENT-2) trials; two identical Phase 3, vehicle-controlled trials in which roflumilast cream 0.15% or vehicle was applied once daily for 4 weeks to individuals 6 years of age and older with mild to moderate AD involving at least 3% body surface area. Roflumilast is a phosphodiesterase-4 (PDE-4) inhibitor.



According to a press release from Arcutis, both studies met the primary endpoint of IGA Success, which was defined as a validated Investigator Global Assessment – Atopic Dermatitis (vIGA-AD) score of ‘clear’ or ‘almost clear’ plus a 2-grade improvement from baseline at week 4. In INTEGUMENT-1 this endpoint was achieved by 32.0% of subjects in the roflumilast cream group vs. 15.2% of those in the vehicle group (P < .0001). In INTEGUMENT-2, this endpoint was achieved by 28.9% of subjects in the roflumilast cream group vs. 12.0% of those in the vehicle group (P < .0001). The most common adverse reactions based on data from the combined trials were headache (2.9%), nausea (1.9%), application-site pain (1.5%), diarrhea (1.5%), and vomiting (1.5%).

Publications
Topics
Sections

 

Arcutis Biotherapeutics has submitted a supplemental New Drug Application (sNDA) to the Food and Drug Administration for roflumilast cream 0.15% for the treatment of mild to moderate atopic dermatitis (AD) in adults and children aged 6 years and older.

Roflumilast cream 0.3% (Zoryve) is currently approved by the FDA for the topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older. Submission of the sNDA is based on positive results from the Interventional Trial Evaluating Roflumilast Cream for the Treatment of Atopic Dermatitis (INTEGUMENT-1 and INTEGUMENT-2) trials; two identical Phase 3, vehicle-controlled trials in which roflumilast cream 0.15% or vehicle was applied once daily for 4 weeks to individuals 6 years of age and older with mild to moderate AD involving at least 3% body surface area. Roflumilast is a phosphodiesterase-4 (PDE-4) inhibitor.



According to a press release from Arcutis, both studies met the primary endpoint of IGA Success, which was defined as a validated Investigator Global Assessment – Atopic Dermatitis (vIGA-AD) score of ‘clear’ or ‘almost clear’ plus a 2-grade improvement from baseline at week 4. In INTEGUMENT-1 this endpoint was achieved by 32.0% of subjects in the roflumilast cream group vs. 15.2% of those in the vehicle group (P < .0001). In INTEGUMENT-2, this endpoint was achieved by 28.9% of subjects in the roflumilast cream group vs. 12.0% of those in the vehicle group (P < .0001). The most common adverse reactions based on data from the combined trials were headache (2.9%), nausea (1.9%), application-site pain (1.5%), diarrhea (1.5%), and vomiting (1.5%).

 

Arcutis Biotherapeutics has submitted a supplemental New Drug Application (sNDA) to the Food and Drug Administration for roflumilast cream 0.15% for the treatment of mild to moderate atopic dermatitis (AD) in adults and children aged 6 years and older.

Roflumilast cream 0.3% (Zoryve) is currently approved by the FDA for the topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older. Submission of the sNDA is based on positive results from the Interventional Trial Evaluating Roflumilast Cream for the Treatment of Atopic Dermatitis (INTEGUMENT-1 and INTEGUMENT-2) trials; two identical Phase 3, vehicle-controlled trials in which roflumilast cream 0.15% or vehicle was applied once daily for 4 weeks to individuals 6 years of age and older with mild to moderate AD involving at least 3% body surface area. Roflumilast is a phosphodiesterase-4 (PDE-4) inhibitor.



According to a press release from Arcutis, both studies met the primary endpoint of IGA Success, which was defined as a validated Investigator Global Assessment – Atopic Dermatitis (vIGA-AD) score of ‘clear’ or ‘almost clear’ plus a 2-grade improvement from baseline at week 4. In INTEGUMENT-1 this endpoint was achieved by 32.0% of subjects in the roflumilast cream group vs. 15.2% of those in the vehicle group (P < .0001). In INTEGUMENT-2, this endpoint was achieved by 28.9% of subjects in the roflumilast cream group vs. 12.0% of those in the vehicle group (P < .0001). The most common adverse reactions based on data from the combined trials were headache (2.9%), nausea (1.9%), application-site pain (1.5%), diarrhea (1.5%), and vomiting (1.5%).

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Skin has different daytime and nighttime needs, emerging circadian research suggests

Article Type
Changed
Thu, 09/07/2023 - 09:12

Emerging research on so-called “clock genes” suggests that the human skin has different daytime and nighttime needs, according to Ava Shamban, MD.

“Paying attention to the circadian rhythm of the skin is every bit as important as moisturizing the skin,” Dr. Shamban, a dermatologist who practices in Santa Monica, Calif., said at the annual Masters of Aesthetics Symposium. “It is paramount to both your morning and evening skin regimen routine,” she added.

Circadian rhythms are physical, mental, and behavioral changes that follow a 24-hour cycle. “These natural processes respond primarily to light and dark and affect most living things, including animals, plants, and microbes,” she said. “The circadian system is composed of peripheral circadian oscillators in many other cells, including the skin.”

The science has been around awhile, but dermatologists didn’t understand its impact until recently, she said.

In 1729, the French astronomer Jean-Jacques d’Ortous de Mairan demonstrated that mimosa leaves, which open at dawn and close at dusk, continued this cycle even when kept in darkness. In the 1970s, Seymour Benzer and Ronald Konopka showed that mutations in an unknown gene disrupted the circadian clock of fruit flies.

And in 2017, the Nobel Prize in Physiology or Medicine was awarded to Jeffrey C. Hall, Michael Rosbash, and Michael W. Young for discovering molecular mechanisms that control circadian rhythm. Using fruit flies as a model, they isolated a gene that controls the normal daily biological rhythm.

“They showed that this gene encodes a protein that accumulates in the cell during the night and is then degraded during the day, and they identified additional protein components, exposing the mechanism governing the self-sustaining clockwork inside the cell,” said Dr. Shamban.

In humans and other mammals, the primary body clock is located in the suprachiasmatic nucleus, a cluster of approximately 10,000 neurons located on either side of the midline above the optic chiasma, about 3 cm behind the eyes. Several clock genes have been identified that regulate and control transcription and translation.



“Expression of these core clock genes inside the cell influences many signaling pathways, which allows the cells to identify the time of day and perform their appropriate function,” Dr. Shamban said. “Furthermore, phosphorylation of core clock proteins leads to degradation to keep the 24-hour cycle in sync.”

Photoreceptive molecules known as opsins also appear to play a role in regulating the skin’s clock. A systematic review of 22 articles published in 2020 found that opsins are present in keratinocytes, melanocytes, dermal fibroblasts, and hair follicle cells, and they have been shown to mediate wound healing, melanogenesis, hair growth, and skin photoaging in human and nonhuman species.

“You may wonder, why does the skin respond so nicely to light?” Dr. Shamban said. “Because it contains opsins, and light exposure through opsin-regulated pathways stimulates melanin production.”

Patients can support their skin’s clock genes by understanding that skin barrier functions such as photoprotection and sebum production are increased during the day, while skin permeability processes such as DNA repair, cell proliferation, and blood flow are enhanced at night.

“Your skin has different daytime and nighttime needs,” Dr. Shamban commented. “Simply put, daytime is defense, and nighttime is offense. I think we’ve known this intuitively, but to know that there is science supporting this idea is important.”

Dr. Shamban wrote the book “Heal Your Skin: The Breakthrough Plan for Renewal” (Wiley, 2011). She disclosed that she conducts clinical trials for many pharmaceutical and device companies.

Meeting/Event
Publications
Topics
Sections
Meeting/Event
Meeting/Event

Emerging research on so-called “clock genes” suggests that the human skin has different daytime and nighttime needs, according to Ava Shamban, MD.

“Paying attention to the circadian rhythm of the skin is every bit as important as moisturizing the skin,” Dr. Shamban, a dermatologist who practices in Santa Monica, Calif., said at the annual Masters of Aesthetics Symposium. “It is paramount to both your morning and evening skin regimen routine,” she added.

Circadian rhythms are physical, mental, and behavioral changes that follow a 24-hour cycle. “These natural processes respond primarily to light and dark and affect most living things, including animals, plants, and microbes,” she said. “The circadian system is composed of peripheral circadian oscillators in many other cells, including the skin.”

The science has been around awhile, but dermatologists didn’t understand its impact until recently, she said.

In 1729, the French astronomer Jean-Jacques d’Ortous de Mairan demonstrated that mimosa leaves, which open at dawn and close at dusk, continued this cycle even when kept in darkness. In the 1970s, Seymour Benzer and Ronald Konopka showed that mutations in an unknown gene disrupted the circadian clock of fruit flies.

And in 2017, the Nobel Prize in Physiology or Medicine was awarded to Jeffrey C. Hall, Michael Rosbash, and Michael W. Young for discovering molecular mechanisms that control circadian rhythm. Using fruit flies as a model, they isolated a gene that controls the normal daily biological rhythm.

“They showed that this gene encodes a protein that accumulates in the cell during the night and is then degraded during the day, and they identified additional protein components, exposing the mechanism governing the self-sustaining clockwork inside the cell,” said Dr. Shamban.

In humans and other mammals, the primary body clock is located in the suprachiasmatic nucleus, a cluster of approximately 10,000 neurons located on either side of the midline above the optic chiasma, about 3 cm behind the eyes. Several clock genes have been identified that regulate and control transcription and translation.



“Expression of these core clock genes inside the cell influences many signaling pathways, which allows the cells to identify the time of day and perform their appropriate function,” Dr. Shamban said. “Furthermore, phosphorylation of core clock proteins leads to degradation to keep the 24-hour cycle in sync.”

Photoreceptive molecules known as opsins also appear to play a role in regulating the skin’s clock. A systematic review of 22 articles published in 2020 found that opsins are present in keratinocytes, melanocytes, dermal fibroblasts, and hair follicle cells, and they have been shown to mediate wound healing, melanogenesis, hair growth, and skin photoaging in human and nonhuman species.

“You may wonder, why does the skin respond so nicely to light?” Dr. Shamban said. “Because it contains opsins, and light exposure through opsin-regulated pathways stimulates melanin production.”

Patients can support their skin’s clock genes by understanding that skin barrier functions such as photoprotection and sebum production are increased during the day, while skin permeability processes such as DNA repair, cell proliferation, and blood flow are enhanced at night.

“Your skin has different daytime and nighttime needs,” Dr. Shamban commented. “Simply put, daytime is defense, and nighttime is offense. I think we’ve known this intuitively, but to know that there is science supporting this idea is important.”

Dr. Shamban wrote the book “Heal Your Skin: The Breakthrough Plan for Renewal” (Wiley, 2011). She disclosed that she conducts clinical trials for many pharmaceutical and device companies.

Emerging research on so-called “clock genes” suggests that the human skin has different daytime and nighttime needs, according to Ava Shamban, MD.

“Paying attention to the circadian rhythm of the skin is every bit as important as moisturizing the skin,” Dr. Shamban, a dermatologist who practices in Santa Monica, Calif., said at the annual Masters of Aesthetics Symposium. “It is paramount to both your morning and evening skin regimen routine,” she added.

Circadian rhythms are physical, mental, and behavioral changes that follow a 24-hour cycle. “These natural processes respond primarily to light and dark and affect most living things, including animals, plants, and microbes,” she said. “The circadian system is composed of peripheral circadian oscillators in many other cells, including the skin.”

The science has been around awhile, but dermatologists didn’t understand its impact until recently, she said.

In 1729, the French astronomer Jean-Jacques d’Ortous de Mairan demonstrated that mimosa leaves, which open at dawn and close at dusk, continued this cycle even when kept in darkness. In the 1970s, Seymour Benzer and Ronald Konopka showed that mutations in an unknown gene disrupted the circadian clock of fruit flies.

And in 2017, the Nobel Prize in Physiology or Medicine was awarded to Jeffrey C. Hall, Michael Rosbash, and Michael W. Young for discovering molecular mechanisms that control circadian rhythm. Using fruit flies as a model, they isolated a gene that controls the normal daily biological rhythm.

“They showed that this gene encodes a protein that accumulates in the cell during the night and is then degraded during the day, and they identified additional protein components, exposing the mechanism governing the self-sustaining clockwork inside the cell,” said Dr. Shamban.

In humans and other mammals, the primary body clock is located in the suprachiasmatic nucleus, a cluster of approximately 10,000 neurons located on either side of the midline above the optic chiasma, about 3 cm behind the eyes. Several clock genes have been identified that regulate and control transcription and translation.



“Expression of these core clock genes inside the cell influences many signaling pathways, which allows the cells to identify the time of day and perform their appropriate function,” Dr. Shamban said. “Furthermore, phosphorylation of core clock proteins leads to degradation to keep the 24-hour cycle in sync.”

Photoreceptive molecules known as opsins also appear to play a role in regulating the skin’s clock. A systematic review of 22 articles published in 2020 found that opsins are present in keratinocytes, melanocytes, dermal fibroblasts, and hair follicle cells, and they have been shown to mediate wound healing, melanogenesis, hair growth, and skin photoaging in human and nonhuman species.

“You may wonder, why does the skin respond so nicely to light?” Dr. Shamban said. “Because it contains opsins, and light exposure through opsin-regulated pathways stimulates melanin production.”

Patients can support their skin’s clock genes by understanding that skin barrier functions such as photoprotection and sebum production are increased during the day, while skin permeability processes such as DNA repair, cell proliferation, and blood flow are enhanced at night.

“Your skin has different daytime and nighttime needs,” Dr. Shamban commented. “Simply put, daytime is defense, and nighttime is offense. I think we’ve known this intuitively, but to know that there is science supporting this idea is important.”

Dr. Shamban wrote the book “Heal Your Skin: The Breakthrough Plan for Renewal” (Wiley, 2011). She disclosed that she conducts clinical trials for many pharmaceutical and device companies.

Publications
Publications
Topics
Article Type
Sections
Article Source

AT MOAS 2023

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

CoolSculpting remains most popular procedure for noninvasive fat removal, expert says

Article Type
Changed
Thu, 09/07/2023 - 18:16

After fashion model Linda Evangelista filed and ultimately settled a lawsuit against Zeltiq Aesthetics in 2022 subsequent to developing paradoxical adipose hyperplasia she claimed was caused by several sessions of CoolSculpting, some aesthetic experts wondered how consumers would embrace the fat reduction procedure going forward.

The negative publicity surrounding this case “is thought to have detracted from some of the volume of it [in terms of demand], but it looks like it’s coming back again,” Omar A. Ibrahimi, MD, PhD, medical director of the Connecticut Skin Institute, Stamford, said during a presentation on noninvasive fat removal treatment options at the annual Masters of Aesthetics Symposium.

Dr. Omar A. Ibrahimi

In fact, he said, CoolSculpting accounts for an estimated 72% of noninvasive fat removal treatments performed in the United States. “By and large, there is high satisfaction with this procedure,” said Dr. Ibrahimi. “There have been about 17 million procedures done worldwide. Paradoxical adipose hyperplasia is a very rare side effect. As newer iterations of this technology have come out, I think there is an even lower incidence.”

CoolSculpting, or cryolipolysis, freezes excess fat to remove it from stubborn areas via panniculitis. The technology was developed by Dieter Manstein MD, PhD, and R. Rox Anderson, MD, at Massachusetts General Hospital and Harvard Medical School, both in Boston, and cleared by the U.S. Food and Drug Administration for noninvasive fat removal in 2010.

“If you kill a fat cell in an adult, it can’t come back,” Dr. Ibrahimi said. “When this technology first came out it was very simple. We treated an area once and were done. Now we know to treat the area multiple times, and you can treat a much larger volume in a patient during one session safely. You can bring about dramatic results, but it often takes a series of 35-minute treatment cycles and about 3 months to see clinical results. There are published studies showing that results are persisting even 10 years after treatment. This is nice, because I tell my patients, ‘if you keep up with your diet and exercise, we don’t expect the fat to come back.’ ”

Other noninvasive options for fat removal include the following:

  • Ultrasound. Options include high-intensity focused ultrasound (Liposonix) and pulsed focused ultrasound (UltraShape). Dr. Ibrahimi described these devices as “very painful, and the results were very difficult to reproduce from the initial clinical studies.”
  • Low-level light therapy. Early devices on the market include Zerona and UltraSlim. “Oftentimes these lacked any sort of histological analysis,” he said. “There was no obvious mechanism of action, and questionable efficacy.”
  • Laser. Powered by a 1060-nm laser, SculpSure can reduce fat cells safely in 25-minute treatment sessions, Dr. Ibrahimi said. Each session is delivered with one of four available applicators and involves 4 minutes of heating and the next 21 minutes alternating between heating and cooling. “You’re trying to reach a target temperature that kills fat cells,” he explained. “The beauty of having these applicators is that you can kind of customize to the individual patient; it uses contact cooling, and it’s safe for all Fitzpatrick skin types. This device results in a 10%-12% reduction in fat, so it’s clinically significant but very modest.”
 

 

A robotic version of the technology, known as the Robotic Fat Killer, is also available. So is the EON, a touchless 1064-nm laser FDA cleared for abdominal, flank, thigh, and back fat reduction. “It adapts to the body shape of the area and individual to deliver a customized treatment,” Dr. Ibrahimi said.

  • Radiofrequency. Most devices on the market, such as truSculpt and Vanquish, are powered by monopolar radiofrequency (RF) energy. “Similar to the 1060-nm laser, you can customize these treatments,” he said. “You’re treating to a target temperature. It involves 15-minute cycles, and there are clinical, histology, and ultrasound data supporting this technology.”


Dr. Ibrahimi uses truSculpt and CoolSculpting in his practice, “but sometimes you have patients who are ‘too fit’ for CoolSculpting; they don’t fit the handpiece perfectly,” he said. “That’s where having a monopolar RF or a 1060-nm laser is useful, to help you hone in on those stubborn pockets of fat.”

  • Deoxycholic acid. While not a device, deoxycholic acid (Kybella), administered subcutaneously, is approved by the FDA for improving “the appearance of moderate to severe convexity or fullness associated with submental fat” in adults. “A lot of people use it off-label on the abdomen and other stubborn areas,” Dr. Ibrahimi said. “It often requires a series of treatments. That’s the biggest limiting issue with using this technology. It works well, but compared to CoolSculpting, there is a lot of swelling and bruising, which you would expect with an injectable. Managing that down time and hand holding is difficult. But if you can get patients to buy into the downtime, [it yields] pretty impressive results.”

Dr. Ibrahimi also discussed the promise of electrical muscle stimulation for strengthening, firming, and toning muscles. The technology applies an electrical current through electrodes placed on the skin, which stimulates muscles, or through an electromagnetic field.



In a published study of 45 men and women, Dr. Ibrahimi, Anne Chapas, MD, medical director of UnionDerm in New York, and colleagues evaluated the safety and efficacy of an electrical muscle stimulation system for improving muscle strength and toning of the upper extremities.

For the treatments, they used disposable contact pads to place pairs of electrodes on the biceps and on the triceps. All patients (median age 42) received 30-minute treatments twice weekly for 2 or 3 weeks, corresponding to four or six total sessions respectively, depending on the study site. Follow-ups were conducted 30 and 90 days after treatment. They used a validated dynamometer device to measure strength at baseline, at the final treatment session, and at the post-treatment 30- and 90-day visits.

“We saw about a 40% increase in strength in the biceps and about a 30% increase in strength in the triceps,” Dr. Ibrahimi said. “Interestingly, the effect got greater at 30 and 90 days, so this is something that lingers on for quite a while.” In addition to the increase in strength, the researchers and patients noted an improvement in the appearance of the arms. He predicted that this technology “is going to play a role in functional medicine and getting injured athletes back to their sports faster.”

Dr. Ibrahimi disclosed that he is a member of the Advisory Board for Accure Acne, AbbVie, Cutera (manufacturer of truSculpt), Lutronic, Blueberry Therapeutics, Cytrellis, and Quthero. He also holds stock in many device and pharmaceutical companies (none are relevant to the treatments mentioned in this story).

Meeting/Event
Publications
Topics
Sections
Meeting/Event
Meeting/Event

After fashion model Linda Evangelista filed and ultimately settled a lawsuit against Zeltiq Aesthetics in 2022 subsequent to developing paradoxical adipose hyperplasia she claimed was caused by several sessions of CoolSculpting, some aesthetic experts wondered how consumers would embrace the fat reduction procedure going forward.

The negative publicity surrounding this case “is thought to have detracted from some of the volume of it [in terms of demand], but it looks like it’s coming back again,” Omar A. Ibrahimi, MD, PhD, medical director of the Connecticut Skin Institute, Stamford, said during a presentation on noninvasive fat removal treatment options at the annual Masters of Aesthetics Symposium.

Dr. Omar A. Ibrahimi

In fact, he said, CoolSculpting accounts for an estimated 72% of noninvasive fat removal treatments performed in the United States. “By and large, there is high satisfaction with this procedure,” said Dr. Ibrahimi. “There have been about 17 million procedures done worldwide. Paradoxical adipose hyperplasia is a very rare side effect. As newer iterations of this technology have come out, I think there is an even lower incidence.”

CoolSculpting, or cryolipolysis, freezes excess fat to remove it from stubborn areas via panniculitis. The technology was developed by Dieter Manstein MD, PhD, and R. Rox Anderson, MD, at Massachusetts General Hospital and Harvard Medical School, both in Boston, and cleared by the U.S. Food and Drug Administration for noninvasive fat removal in 2010.

“If you kill a fat cell in an adult, it can’t come back,” Dr. Ibrahimi said. “When this technology first came out it was very simple. We treated an area once and were done. Now we know to treat the area multiple times, and you can treat a much larger volume in a patient during one session safely. You can bring about dramatic results, but it often takes a series of 35-minute treatment cycles and about 3 months to see clinical results. There are published studies showing that results are persisting even 10 years after treatment. This is nice, because I tell my patients, ‘if you keep up with your diet and exercise, we don’t expect the fat to come back.’ ”

Other noninvasive options for fat removal include the following:

  • Ultrasound. Options include high-intensity focused ultrasound (Liposonix) and pulsed focused ultrasound (UltraShape). Dr. Ibrahimi described these devices as “very painful, and the results were very difficult to reproduce from the initial clinical studies.”
  • Low-level light therapy. Early devices on the market include Zerona and UltraSlim. “Oftentimes these lacked any sort of histological analysis,” he said. “There was no obvious mechanism of action, and questionable efficacy.”
  • Laser. Powered by a 1060-nm laser, SculpSure can reduce fat cells safely in 25-minute treatment sessions, Dr. Ibrahimi said. Each session is delivered with one of four available applicators and involves 4 minutes of heating and the next 21 minutes alternating between heating and cooling. “You’re trying to reach a target temperature that kills fat cells,” he explained. “The beauty of having these applicators is that you can kind of customize to the individual patient; it uses contact cooling, and it’s safe for all Fitzpatrick skin types. This device results in a 10%-12% reduction in fat, so it’s clinically significant but very modest.”
 

 

A robotic version of the technology, known as the Robotic Fat Killer, is also available. So is the EON, a touchless 1064-nm laser FDA cleared for abdominal, flank, thigh, and back fat reduction. “It adapts to the body shape of the area and individual to deliver a customized treatment,” Dr. Ibrahimi said.

  • Radiofrequency. Most devices on the market, such as truSculpt and Vanquish, are powered by monopolar radiofrequency (RF) energy. “Similar to the 1060-nm laser, you can customize these treatments,” he said. “You’re treating to a target temperature. It involves 15-minute cycles, and there are clinical, histology, and ultrasound data supporting this technology.”


Dr. Ibrahimi uses truSculpt and CoolSculpting in his practice, “but sometimes you have patients who are ‘too fit’ for CoolSculpting; they don’t fit the handpiece perfectly,” he said. “That’s where having a monopolar RF or a 1060-nm laser is useful, to help you hone in on those stubborn pockets of fat.”

  • Deoxycholic acid. While not a device, deoxycholic acid (Kybella), administered subcutaneously, is approved by the FDA for improving “the appearance of moderate to severe convexity or fullness associated with submental fat” in adults. “A lot of people use it off-label on the abdomen and other stubborn areas,” Dr. Ibrahimi said. “It often requires a series of treatments. That’s the biggest limiting issue with using this technology. It works well, but compared to CoolSculpting, there is a lot of swelling and bruising, which you would expect with an injectable. Managing that down time and hand holding is difficult. But if you can get patients to buy into the downtime, [it yields] pretty impressive results.”

Dr. Ibrahimi also discussed the promise of electrical muscle stimulation for strengthening, firming, and toning muscles. The technology applies an electrical current through electrodes placed on the skin, which stimulates muscles, or through an electromagnetic field.



In a published study of 45 men and women, Dr. Ibrahimi, Anne Chapas, MD, medical director of UnionDerm in New York, and colleagues evaluated the safety and efficacy of an electrical muscle stimulation system for improving muscle strength and toning of the upper extremities.

For the treatments, they used disposable contact pads to place pairs of electrodes on the biceps and on the triceps. All patients (median age 42) received 30-minute treatments twice weekly for 2 or 3 weeks, corresponding to four or six total sessions respectively, depending on the study site. Follow-ups were conducted 30 and 90 days after treatment. They used a validated dynamometer device to measure strength at baseline, at the final treatment session, and at the post-treatment 30- and 90-day visits.

“We saw about a 40% increase in strength in the biceps and about a 30% increase in strength in the triceps,” Dr. Ibrahimi said. “Interestingly, the effect got greater at 30 and 90 days, so this is something that lingers on for quite a while.” In addition to the increase in strength, the researchers and patients noted an improvement in the appearance of the arms. He predicted that this technology “is going to play a role in functional medicine and getting injured athletes back to their sports faster.”

Dr. Ibrahimi disclosed that he is a member of the Advisory Board for Accure Acne, AbbVie, Cutera (manufacturer of truSculpt), Lutronic, Blueberry Therapeutics, Cytrellis, and Quthero. He also holds stock in many device and pharmaceutical companies (none are relevant to the treatments mentioned in this story).

After fashion model Linda Evangelista filed and ultimately settled a lawsuit against Zeltiq Aesthetics in 2022 subsequent to developing paradoxical adipose hyperplasia she claimed was caused by several sessions of CoolSculpting, some aesthetic experts wondered how consumers would embrace the fat reduction procedure going forward.

The negative publicity surrounding this case “is thought to have detracted from some of the volume of it [in terms of demand], but it looks like it’s coming back again,” Omar A. Ibrahimi, MD, PhD, medical director of the Connecticut Skin Institute, Stamford, said during a presentation on noninvasive fat removal treatment options at the annual Masters of Aesthetics Symposium.

Dr. Omar A. Ibrahimi

In fact, he said, CoolSculpting accounts for an estimated 72% of noninvasive fat removal treatments performed in the United States. “By and large, there is high satisfaction with this procedure,” said Dr. Ibrahimi. “There have been about 17 million procedures done worldwide. Paradoxical adipose hyperplasia is a very rare side effect. As newer iterations of this technology have come out, I think there is an even lower incidence.”

CoolSculpting, or cryolipolysis, freezes excess fat to remove it from stubborn areas via panniculitis. The technology was developed by Dieter Manstein MD, PhD, and R. Rox Anderson, MD, at Massachusetts General Hospital and Harvard Medical School, both in Boston, and cleared by the U.S. Food and Drug Administration for noninvasive fat removal in 2010.

“If you kill a fat cell in an adult, it can’t come back,” Dr. Ibrahimi said. “When this technology first came out it was very simple. We treated an area once and were done. Now we know to treat the area multiple times, and you can treat a much larger volume in a patient during one session safely. You can bring about dramatic results, but it often takes a series of 35-minute treatment cycles and about 3 months to see clinical results. There are published studies showing that results are persisting even 10 years after treatment. This is nice, because I tell my patients, ‘if you keep up with your diet and exercise, we don’t expect the fat to come back.’ ”

Other noninvasive options for fat removal include the following:

  • Ultrasound. Options include high-intensity focused ultrasound (Liposonix) and pulsed focused ultrasound (UltraShape). Dr. Ibrahimi described these devices as “very painful, and the results were very difficult to reproduce from the initial clinical studies.”
  • Low-level light therapy. Early devices on the market include Zerona and UltraSlim. “Oftentimes these lacked any sort of histological analysis,” he said. “There was no obvious mechanism of action, and questionable efficacy.”
  • Laser. Powered by a 1060-nm laser, SculpSure can reduce fat cells safely in 25-minute treatment sessions, Dr. Ibrahimi said. Each session is delivered with one of four available applicators and involves 4 minutes of heating and the next 21 minutes alternating between heating and cooling. “You’re trying to reach a target temperature that kills fat cells,” he explained. “The beauty of having these applicators is that you can kind of customize to the individual patient; it uses contact cooling, and it’s safe for all Fitzpatrick skin types. This device results in a 10%-12% reduction in fat, so it’s clinically significant but very modest.”
 

 

A robotic version of the technology, known as the Robotic Fat Killer, is also available. So is the EON, a touchless 1064-nm laser FDA cleared for abdominal, flank, thigh, and back fat reduction. “It adapts to the body shape of the area and individual to deliver a customized treatment,” Dr. Ibrahimi said.

  • Radiofrequency. Most devices on the market, such as truSculpt and Vanquish, are powered by monopolar radiofrequency (RF) energy. “Similar to the 1060-nm laser, you can customize these treatments,” he said. “You’re treating to a target temperature. It involves 15-minute cycles, and there are clinical, histology, and ultrasound data supporting this technology.”


Dr. Ibrahimi uses truSculpt and CoolSculpting in his practice, “but sometimes you have patients who are ‘too fit’ for CoolSculpting; they don’t fit the handpiece perfectly,” he said. “That’s where having a monopolar RF or a 1060-nm laser is useful, to help you hone in on those stubborn pockets of fat.”

  • Deoxycholic acid. While not a device, deoxycholic acid (Kybella), administered subcutaneously, is approved by the FDA for improving “the appearance of moderate to severe convexity or fullness associated with submental fat” in adults. “A lot of people use it off-label on the abdomen and other stubborn areas,” Dr. Ibrahimi said. “It often requires a series of treatments. That’s the biggest limiting issue with using this technology. It works well, but compared to CoolSculpting, there is a lot of swelling and bruising, which you would expect with an injectable. Managing that down time and hand holding is difficult. But if you can get patients to buy into the downtime, [it yields] pretty impressive results.”

Dr. Ibrahimi also discussed the promise of electrical muscle stimulation for strengthening, firming, and toning muscles. The technology applies an electrical current through electrodes placed on the skin, which stimulates muscles, or through an electromagnetic field.



In a published study of 45 men and women, Dr. Ibrahimi, Anne Chapas, MD, medical director of UnionDerm in New York, and colleagues evaluated the safety and efficacy of an electrical muscle stimulation system for improving muscle strength and toning of the upper extremities.

For the treatments, they used disposable contact pads to place pairs of electrodes on the biceps and on the triceps. All patients (median age 42) received 30-minute treatments twice weekly for 2 or 3 weeks, corresponding to four or six total sessions respectively, depending on the study site. Follow-ups were conducted 30 and 90 days after treatment. They used a validated dynamometer device to measure strength at baseline, at the final treatment session, and at the post-treatment 30- and 90-day visits.

“We saw about a 40% increase in strength in the biceps and about a 30% increase in strength in the triceps,” Dr. Ibrahimi said. “Interestingly, the effect got greater at 30 and 90 days, so this is something that lingers on for quite a while.” In addition to the increase in strength, the researchers and patients noted an improvement in the appearance of the arms. He predicted that this technology “is going to play a role in functional medicine and getting injured athletes back to their sports faster.”

Dr. Ibrahimi disclosed that he is a member of the Advisory Board for Accure Acne, AbbVie, Cutera (manufacturer of truSculpt), Lutronic, Blueberry Therapeutics, Cytrellis, and Quthero. He also holds stock in many device and pharmaceutical companies (none are relevant to the treatments mentioned in this story).

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Going into solo practice? An expert shares tips

Article Type
Changed
Thu, 09/07/2023 - 15:02

 

When the Boston-based cosmetic dermatology practice that employed Catherine M. DiGiorgio, MD, MS, was sold to a private equity firm a few years ago, she found herself at a crossroads: Stay and work for a large corporation, or open a solo practice?

She opted to start her own practice in Boston, “because I didn’t want to work for a large corporation, and I want to provide the best care for my patients in a more intimate manner,” Dr. DiGiorgio, a board-certified laser and cosmetic dermatologist, said at the annual Masters of Aesthetics Symposium.

Dr. DiGiorgio
Dr. Catherine M. DiGiorgio

The decision also tested her mettle. “I spoke to several colleagues and friends, and I was terrified,” she said. “I was like: ‘I don’t even know where to start.’ ”

On the heels of opening a new office in a matter of weeks, she offered the following tips and questions to consider when launching a solo dermatology practice:

Select a location. “That’s your first decision,” she said. “Where in the city are you going to open? Are you going to a new city, or are you moving back home? Don’t be afraid to start from scratch, and don’t be afraid to start a [solo] practice if you already have a patient base.”

Will you lease or purchase your space? After she secured a bank loan, Dr. DiGiorgio chose to lease the space for her new practice, “because you can kind of see where things go, get all the kinks out and figure out how to build things in a space that you don’t own. Then, when you’re ready and you have grown, you can invest more into your practice.”

Will you accept insurance? She built her practice around the direct specialty care model, which emphasizes the patient-physician relationship and removes third-party payors. “It’s not a concierge practice, but it’s a transparent, reasonable fee schedule for medical dermatology,” she explained. “I’ve done 100% cosmetics for about 5 years now, [but] I do medical dermatology for a fee. On my website I have a full price list on how much a full skin check is, [and] how much biopsies are. It’s completely transparent. Patients can submit to their insurance for reimbursement, but we don’t guarantee that they’re going to be reimbursed.”

Where will your patients come from? Will you advertise? Do you have physicians in the area who will refer to you if you’re a board-certified dermatologist? She emphasized the importance of “learning how to present yourself” on a website dedicated to your own practice. “Instagram, Facebook, and social media are great, but you don’t own those pages,” noted Dr. DiGiorgio, who served as the program cochair of the 2023 annual meeting of the American Society for Laser Medicine and Surgery and was recently elected to serve on the board of directors for the American Society for Dermatology Surgery. “You don’t own one of those pictures that are posted on your social media page. They can disappear in a second. If that happens, how are people going to find you?”

Are you going to hire more physicians in the future? That will influence the size of the new office and the floor plan.

Lawyer up. Hiring a health care attorney can “help you navigate transitioning from whatever position you’re in to opening up your own practice, as well as setting up the regulatory paperwork necessary for your new practice. You’ll also need a real estate attorney to help once you have selected a place, to help you navigate through that process,” she said, such as figuring out if the elevator in the building meets the Americans With Disabilities Act (ADA) requirements.

Create a mission statement. That way, “you know why you’re doing this, and it stays with you as you’re getting through the hard roadblocks.”

Find an architect, contractor, or designer. “If you’re building out a space from scratch, you’re going to need an architect,” she said. “Along with that architect will come a full-on contracting firm. I ended up hiring everyone individually, because I’m trying to spend as little money as possible.” She also hired a designer to help select furnishings and create the office atmosphere.

Secure a building permit ASAP. “It’s almost better to have the city permit before you sign the lease, because the permits can take a year, and you don’t want to pay rent on an empty space for a year if you don’t have a permit or if there are other hoops to go through,” Dr. DiGiorgio said.

Find an agent to help you set up medical malpractice insurance, liability insurance, and worker’s compensation insurance. “Make sure you read all the paperwork, because it can be very intricate,” she said.

Find an accountant. That person can help set up a bookkeeping process.

What equipment and devices will you need? That depends largely on the patient population a physician serves. Dr. DiGiorgio noted that eligible small businesses may take a tax credit of up to $5,000 per year for accommodations made to comply with the ADA. “That’s a nice feature, so that you can purchase ADA compliant items like a larger exam chair and custom reception areas.”

Dr. DiGiorgio reported having no relevant disclosures.

Meeting/Event
Publications
Topics
Sections
Meeting/Event
Meeting/Event

 

When the Boston-based cosmetic dermatology practice that employed Catherine M. DiGiorgio, MD, MS, was sold to a private equity firm a few years ago, she found herself at a crossroads: Stay and work for a large corporation, or open a solo practice?

She opted to start her own practice in Boston, “because I didn’t want to work for a large corporation, and I want to provide the best care for my patients in a more intimate manner,” Dr. DiGiorgio, a board-certified laser and cosmetic dermatologist, said at the annual Masters of Aesthetics Symposium.

Dr. DiGiorgio
Dr. Catherine M. DiGiorgio

The decision also tested her mettle. “I spoke to several colleagues and friends, and I was terrified,” she said. “I was like: ‘I don’t even know where to start.’ ”

On the heels of opening a new office in a matter of weeks, she offered the following tips and questions to consider when launching a solo dermatology practice:

Select a location. “That’s your first decision,” she said. “Where in the city are you going to open? Are you going to a new city, or are you moving back home? Don’t be afraid to start from scratch, and don’t be afraid to start a [solo] practice if you already have a patient base.”

Will you lease or purchase your space? After she secured a bank loan, Dr. DiGiorgio chose to lease the space for her new practice, “because you can kind of see where things go, get all the kinks out and figure out how to build things in a space that you don’t own. Then, when you’re ready and you have grown, you can invest more into your practice.”

Will you accept insurance? She built her practice around the direct specialty care model, which emphasizes the patient-physician relationship and removes third-party payors. “It’s not a concierge practice, but it’s a transparent, reasonable fee schedule for medical dermatology,” she explained. “I’ve done 100% cosmetics for about 5 years now, [but] I do medical dermatology for a fee. On my website I have a full price list on how much a full skin check is, [and] how much biopsies are. It’s completely transparent. Patients can submit to their insurance for reimbursement, but we don’t guarantee that they’re going to be reimbursed.”

Where will your patients come from? Will you advertise? Do you have physicians in the area who will refer to you if you’re a board-certified dermatologist? She emphasized the importance of “learning how to present yourself” on a website dedicated to your own practice. “Instagram, Facebook, and social media are great, but you don’t own those pages,” noted Dr. DiGiorgio, who served as the program cochair of the 2023 annual meeting of the American Society for Laser Medicine and Surgery and was recently elected to serve on the board of directors for the American Society for Dermatology Surgery. “You don’t own one of those pictures that are posted on your social media page. They can disappear in a second. If that happens, how are people going to find you?”

Are you going to hire more physicians in the future? That will influence the size of the new office and the floor plan.

Lawyer up. Hiring a health care attorney can “help you navigate transitioning from whatever position you’re in to opening up your own practice, as well as setting up the regulatory paperwork necessary for your new practice. You’ll also need a real estate attorney to help once you have selected a place, to help you navigate through that process,” she said, such as figuring out if the elevator in the building meets the Americans With Disabilities Act (ADA) requirements.

Create a mission statement. That way, “you know why you’re doing this, and it stays with you as you’re getting through the hard roadblocks.”

Find an architect, contractor, or designer. “If you’re building out a space from scratch, you’re going to need an architect,” she said. “Along with that architect will come a full-on contracting firm. I ended up hiring everyone individually, because I’m trying to spend as little money as possible.” She also hired a designer to help select furnishings and create the office atmosphere.

Secure a building permit ASAP. “It’s almost better to have the city permit before you sign the lease, because the permits can take a year, and you don’t want to pay rent on an empty space for a year if you don’t have a permit or if there are other hoops to go through,” Dr. DiGiorgio said.

Find an agent to help you set up medical malpractice insurance, liability insurance, and worker’s compensation insurance. “Make sure you read all the paperwork, because it can be very intricate,” she said.

Find an accountant. That person can help set up a bookkeeping process.

What equipment and devices will you need? That depends largely on the patient population a physician serves. Dr. DiGiorgio noted that eligible small businesses may take a tax credit of up to $5,000 per year for accommodations made to comply with the ADA. “That’s a nice feature, so that you can purchase ADA compliant items like a larger exam chair and custom reception areas.”

Dr. DiGiorgio reported having no relevant disclosures.

 

When the Boston-based cosmetic dermatology practice that employed Catherine M. DiGiorgio, MD, MS, was sold to a private equity firm a few years ago, she found herself at a crossroads: Stay and work for a large corporation, or open a solo practice?

She opted to start her own practice in Boston, “because I didn’t want to work for a large corporation, and I want to provide the best care for my patients in a more intimate manner,” Dr. DiGiorgio, a board-certified laser and cosmetic dermatologist, said at the annual Masters of Aesthetics Symposium.

Dr. DiGiorgio
Dr. Catherine M. DiGiorgio

The decision also tested her mettle. “I spoke to several colleagues and friends, and I was terrified,” she said. “I was like: ‘I don’t even know where to start.’ ”

On the heels of opening a new office in a matter of weeks, she offered the following tips and questions to consider when launching a solo dermatology practice:

Select a location. “That’s your first decision,” she said. “Where in the city are you going to open? Are you going to a new city, or are you moving back home? Don’t be afraid to start from scratch, and don’t be afraid to start a [solo] practice if you already have a patient base.”

Will you lease or purchase your space? After she secured a bank loan, Dr. DiGiorgio chose to lease the space for her new practice, “because you can kind of see where things go, get all the kinks out and figure out how to build things in a space that you don’t own. Then, when you’re ready and you have grown, you can invest more into your practice.”

Will you accept insurance? She built her practice around the direct specialty care model, which emphasizes the patient-physician relationship and removes third-party payors. “It’s not a concierge practice, but it’s a transparent, reasonable fee schedule for medical dermatology,” she explained. “I’ve done 100% cosmetics for about 5 years now, [but] I do medical dermatology for a fee. On my website I have a full price list on how much a full skin check is, [and] how much biopsies are. It’s completely transparent. Patients can submit to their insurance for reimbursement, but we don’t guarantee that they’re going to be reimbursed.”

Where will your patients come from? Will you advertise? Do you have physicians in the area who will refer to you if you’re a board-certified dermatologist? She emphasized the importance of “learning how to present yourself” on a website dedicated to your own practice. “Instagram, Facebook, and social media are great, but you don’t own those pages,” noted Dr. DiGiorgio, who served as the program cochair of the 2023 annual meeting of the American Society for Laser Medicine and Surgery and was recently elected to serve on the board of directors for the American Society for Dermatology Surgery. “You don’t own one of those pictures that are posted on your social media page. They can disappear in a second. If that happens, how are people going to find you?”

Are you going to hire more physicians in the future? That will influence the size of the new office and the floor plan.

Lawyer up. Hiring a health care attorney can “help you navigate transitioning from whatever position you’re in to opening up your own practice, as well as setting up the regulatory paperwork necessary for your new practice. You’ll also need a real estate attorney to help once you have selected a place, to help you navigate through that process,” she said, such as figuring out if the elevator in the building meets the Americans With Disabilities Act (ADA) requirements.

Create a mission statement. That way, “you know why you’re doing this, and it stays with you as you’re getting through the hard roadblocks.”

Find an architect, contractor, or designer. “If you’re building out a space from scratch, you’re going to need an architect,” she said. “Along with that architect will come a full-on contracting firm. I ended up hiring everyone individually, because I’m trying to spend as little money as possible.” She also hired a designer to help select furnishings and create the office atmosphere.

Secure a building permit ASAP. “It’s almost better to have the city permit before you sign the lease, because the permits can take a year, and you don’t want to pay rent on an empty space for a year if you don’t have a permit or if there are other hoops to go through,” Dr. DiGiorgio said.

Find an agent to help you set up medical malpractice insurance, liability insurance, and worker’s compensation insurance. “Make sure you read all the paperwork, because it can be very intricate,” she said.

Find an accountant. That person can help set up a bookkeeping process.

What equipment and devices will you need? That depends largely on the patient population a physician serves. Dr. DiGiorgio noted that eligible small businesses may take a tax credit of up to $5,000 per year for accommodations made to comply with the ADA. “That’s a nice feature, so that you can purchase ADA compliant items like a larger exam chair and custom reception areas.”

Dr. DiGiorgio reported having no relevant disclosures.

Publications
Publications
Topics
Article Type
Sections
Article Source

AT MOAS 2023

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

When is antibiotic prophylaxis required for dermatologic surgery?

Article Type
Changed
Tue, 08/29/2023 - 15:06

– The need for antibiotic prophylaxis in dermatologic surgery depends on the type of procedure, the patient, what infection you’re trying to keep at bay, and the type of wound, according to Tissa Hata, MD, professor of dermatology at the University of California, San Diego.

Among the many studies in the medical literature that have examined the use of antibiotics to prevent surgical site infections, one study published in 2006 has the largest number of patients to date, Dr. Hata said at a conference on superficial anatomy and cutaneous surgery sponsored by UCSD and Scripps Clinic. In the prospective study of wound infections in patients undergoing dermatologic surgery without prophylactic antibiotics, researchers in Australia prospectively examined 5,091 lesions, mostly nonmelanoma skin cancers, in 2,424 patients over the course of 3 years.

By procedure, the infection rate was highest for skin grafts (8.70%) and wedge excision of the lip or ear (8.57%), followed by skin flap repairs (2.94%), curettage (0.73%), and simple excision and closure (0.54%). By anatomic site, groin excisional surgery had the highest infection rate (10%), followed by surgical procedures below the knee (6.92%), while those performed on the face had a low rate (0.81%). “Based on their analysis, they suggest antibiotic prophylaxis for all procedures below the knee and groin, wedge excisions of the lip and ear, and all skin grafts,” Dr. Hata said.

In 2008, an advisory statement published in the Journal of the American Academy of Dermatology expanded the procedure location and techniques requiring antibiotic prophylaxis to include procedures on the nose and the lower extremity (especially the leg), and for patients with extensive inflammatory disease. According to the statement, in patients without a penicillin allergy, the suggested antibiotic prophylaxis regimen for wedge excision of the lip/ear, flaps on the nose, or all skin grafts include 2 g oral cephalexin or dicloxacillin. In patients with penicillin allergy, the recommended prophylaxis regimen for wedge excision of the lip/ear, flaps on the nose, or all skin grafts include 600 mg oral clindamycin or 500 mg oral azithromycin/clarithromycin.

In the statement, for patients with no penicillin allergy, the suggested prophylaxis regimen for lesions in the groin or on the lower extremities include 2 g oral cephalexin, 1 tablet of oral trimethoprim/sulfamethoxazole (TMP-SMX) DS, or 500 mg of levofloxacin. In patients with penicillin allergy, the recommended prophylaxis regimen for lesions on the groin and lower extremities is 1 tablet of TMP-SMX DS or 500 mg of levofloxacin.

In 2020, a meta-analysis of surgical site infections in patients undergoing Mohs surgery of the ear and nose found that there was no difference in infections in those locations whether patients received oral antibiotic prophylaxis or not. “But the researchers did not specify the type of closure, whether it was a graft or a flap closure,” Dr. Hata commented.


Endocarditis prophylaxis

Dr. Hata also discussed antibiotic recommendations for endocarditis prophylaxis, noting that the mortality rate from endocarditis is as high as 76%, and an estimated 40% of affected patients require heart valve replacement within 5-8 years. “But the good news is that fewer than 10 cases have been possibly linked to dermatologic procedures,” she said.

During outpatient dermatologic surgery, the incidence of bacteremia is in the range of 1.9%-3%, similar to the incidence of 2% that occurs spontaneously in healthy adults, according to Dr. Hata. She said that the following activities or procedures pose a much higher risk of bacteremia: mastication (17%-24%), tooth brushing (24%-40%), tooth extraction (60%-90%), and incision and drainage of an abscess (38%).

American Heart Association guidelines from 2007 recommend antibiotic prophylaxis in only the highest-risk categories of patients. These guidelines were updated in 2017 to include patients with transcatheter prosthetic valves and those with prosthetic material in valve repair. “The primary reason for revision of guidelines is that endocarditis is much more likely to result from frequent exposure to random bacteremia associated with daily activity such as brushing our teeth or having a tooth extracted,” Dr. Hata explained. “Prophylaxis may prevent an exceedingly small number of cases. Authors of the guidelines concluded that the risk of antibiotic-associated adverse event exceeds the benefit of prophylactic therapy, and that maintenance of optimal oral health is more important than prophylactic antibiotics.”

The 2017 AHA guidelines recommend antibiotic prophylaxis in patients with the following cardiac conditions: those with a prosthetic cardiac valve including transcatheter-implanted prostheses and homografts; those with previous endocarditis; those with prosthetic material used for heart valve repair, such as annuloplasty rings, chords or clips; cardiac transplantation recipients who develop cardiac valvulopathy; and those with certain types of congenital heart disease, including unrepaired cyanotic CHD, a completely repaired congenital heart defect with a prosthetic material or device during the first 6 months after the procedure, and repaired CHD with residual defects at the site or adjacent to the site of a prosthetic patch or prosthetic device.

Procedures that may require prophylaxis for endocarditis include all dental procedures that involve manipulation of the gingival tissue or the periapical region of teeth or perforation of the oral mucosa, and respiratory tract procedures that involve incision or biopsy of the respiratory mucosa such as tonsillectomy or adenoidectomy. Antibiotic prophylaxis is not recommended for procedures involving the gastrointestinal tract or the genitourinary tract unless an active infection is present. As for skin procedures, the guidelines recommend antibiotic prophylaxis for patients in the high-risk category who undergo a surgical procedure that involves infected skin, skin structure, or musculoskeletal tissue.

In the 2017 AHA guidelines, patients with no penicillin allergy, the suggested antibiotic prophylaxis regimen for endocarditis in non-oral sites includes 2 g oral cephalexin or dicloxacillin, while in patients with penicillin allergy, the suggested prophylaxis for endocarditis in non-oral sites includes 600 mg oral clindamycin or 500 mg oral azithromycin/clarithromycin. In patients without a penicillin allergy, the suggested prophylaxis for endocarditis in oral sites is 2 g oral amoxicillin, while in those with penicillin allergy, the suggested antibiotic prophylaxis for endocarditis in oral sites is 500 mg azithromycin/clarithromycin or doxycycline 100 mg.

“Antibiotic prophylaxis for endocarditis should be given 30-60 minutes prior to surgery, and a follow-up dose of antibiotics is no longer recommended,” Dr. Hata said. “If you forget [to administer the antibiotics] or the patient forgets, antibiotics may be given up to 2 hours after the procedure.”

Dr. Hata reported having no relevant disclosures.

Publications
Topics
Sections

– The need for antibiotic prophylaxis in dermatologic surgery depends on the type of procedure, the patient, what infection you’re trying to keep at bay, and the type of wound, according to Tissa Hata, MD, professor of dermatology at the University of California, San Diego.

Among the many studies in the medical literature that have examined the use of antibiotics to prevent surgical site infections, one study published in 2006 has the largest number of patients to date, Dr. Hata said at a conference on superficial anatomy and cutaneous surgery sponsored by UCSD and Scripps Clinic. In the prospective study of wound infections in patients undergoing dermatologic surgery without prophylactic antibiotics, researchers in Australia prospectively examined 5,091 lesions, mostly nonmelanoma skin cancers, in 2,424 patients over the course of 3 years.

By procedure, the infection rate was highest for skin grafts (8.70%) and wedge excision of the lip or ear (8.57%), followed by skin flap repairs (2.94%), curettage (0.73%), and simple excision and closure (0.54%). By anatomic site, groin excisional surgery had the highest infection rate (10%), followed by surgical procedures below the knee (6.92%), while those performed on the face had a low rate (0.81%). “Based on their analysis, they suggest antibiotic prophylaxis for all procedures below the knee and groin, wedge excisions of the lip and ear, and all skin grafts,” Dr. Hata said.

In 2008, an advisory statement published in the Journal of the American Academy of Dermatology expanded the procedure location and techniques requiring antibiotic prophylaxis to include procedures on the nose and the lower extremity (especially the leg), and for patients with extensive inflammatory disease. According to the statement, in patients without a penicillin allergy, the suggested antibiotic prophylaxis regimen for wedge excision of the lip/ear, flaps on the nose, or all skin grafts include 2 g oral cephalexin or dicloxacillin. In patients with penicillin allergy, the recommended prophylaxis regimen for wedge excision of the lip/ear, flaps on the nose, or all skin grafts include 600 mg oral clindamycin or 500 mg oral azithromycin/clarithromycin.

In the statement, for patients with no penicillin allergy, the suggested prophylaxis regimen for lesions in the groin or on the lower extremities include 2 g oral cephalexin, 1 tablet of oral trimethoprim/sulfamethoxazole (TMP-SMX) DS, or 500 mg of levofloxacin. In patients with penicillin allergy, the recommended prophylaxis regimen for lesions on the groin and lower extremities is 1 tablet of TMP-SMX DS or 500 mg of levofloxacin.

In 2020, a meta-analysis of surgical site infections in patients undergoing Mohs surgery of the ear and nose found that there was no difference in infections in those locations whether patients received oral antibiotic prophylaxis or not. “But the researchers did not specify the type of closure, whether it was a graft or a flap closure,” Dr. Hata commented.


Endocarditis prophylaxis

Dr. Hata also discussed antibiotic recommendations for endocarditis prophylaxis, noting that the mortality rate from endocarditis is as high as 76%, and an estimated 40% of affected patients require heart valve replacement within 5-8 years. “But the good news is that fewer than 10 cases have been possibly linked to dermatologic procedures,” she said.

During outpatient dermatologic surgery, the incidence of bacteremia is in the range of 1.9%-3%, similar to the incidence of 2% that occurs spontaneously in healthy adults, according to Dr. Hata. She said that the following activities or procedures pose a much higher risk of bacteremia: mastication (17%-24%), tooth brushing (24%-40%), tooth extraction (60%-90%), and incision and drainage of an abscess (38%).

American Heart Association guidelines from 2007 recommend antibiotic prophylaxis in only the highest-risk categories of patients. These guidelines were updated in 2017 to include patients with transcatheter prosthetic valves and those with prosthetic material in valve repair. “The primary reason for revision of guidelines is that endocarditis is much more likely to result from frequent exposure to random bacteremia associated with daily activity such as brushing our teeth or having a tooth extracted,” Dr. Hata explained. “Prophylaxis may prevent an exceedingly small number of cases. Authors of the guidelines concluded that the risk of antibiotic-associated adverse event exceeds the benefit of prophylactic therapy, and that maintenance of optimal oral health is more important than prophylactic antibiotics.”

The 2017 AHA guidelines recommend antibiotic prophylaxis in patients with the following cardiac conditions: those with a prosthetic cardiac valve including transcatheter-implanted prostheses and homografts; those with previous endocarditis; those with prosthetic material used for heart valve repair, such as annuloplasty rings, chords or clips; cardiac transplantation recipients who develop cardiac valvulopathy; and those with certain types of congenital heart disease, including unrepaired cyanotic CHD, a completely repaired congenital heart defect with a prosthetic material or device during the first 6 months after the procedure, and repaired CHD with residual defects at the site or adjacent to the site of a prosthetic patch or prosthetic device.

Procedures that may require prophylaxis for endocarditis include all dental procedures that involve manipulation of the gingival tissue or the periapical region of teeth or perforation of the oral mucosa, and respiratory tract procedures that involve incision or biopsy of the respiratory mucosa such as tonsillectomy or adenoidectomy. Antibiotic prophylaxis is not recommended for procedures involving the gastrointestinal tract or the genitourinary tract unless an active infection is present. As for skin procedures, the guidelines recommend antibiotic prophylaxis for patients in the high-risk category who undergo a surgical procedure that involves infected skin, skin structure, or musculoskeletal tissue.

In the 2017 AHA guidelines, patients with no penicillin allergy, the suggested antibiotic prophylaxis regimen for endocarditis in non-oral sites includes 2 g oral cephalexin or dicloxacillin, while in patients with penicillin allergy, the suggested prophylaxis for endocarditis in non-oral sites includes 600 mg oral clindamycin or 500 mg oral azithromycin/clarithromycin. In patients without a penicillin allergy, the suggested prophylaxis for endocarditis in oral sites is 2 g oral amoxicillin, while in those with penicillin allergy, the suggested antibiotic prophylaxis for endocarditis in oral sites is 500 mg azithromycin/clarithromycin or doxycycline 100 mg.

“Antibiotic prophylaxis for endocarditis should be given 30-60 minutes prior to surgery, and a follow-up dose of antibiotics is no longer recommended,” Dr. Hata said. “If you forget [to administer the antibiotics] or the patient forgets, antibiotics may be given up to 2 hours after the procedure.”

Dr. Hata reported having no relevant disclosures.

– The need for antibiotic prophylaxis in dermatologic surgery depends on the type of procedure, the patient, what infection you’re trying to keep at bay, and the type of wound, according to Tissa Hata, MD, professor of dermatology at the University of California, San Diego.

Among the many studies in the medical literature that have examined the use of antibiotics to prevent surgical site infections, one study published in 2006 has the largest number of patients to date, Dr. Hata said at a conference on superficial anatomy and cutaneous surgery sponsored by UCSD and Scripps Clinic. In the prospective study of wound infections in patients undergoing dermatologic surgery without prophylactic antibiotics, researchers in Australia prospectively examined 5,091 lesions, mostly nonmelanoma skin cancers, in 2,424 patients over the course of 3 years.

By procedure, the infection rate was highest for skin grafts (8.70%) and wedge excision of the lip or ear (8.57%), followed by skin flap repairs (2.94%), curettage (0.73%), and simple excision and closure (0.54%). By anatomic site, groin excisional surgery had the highest infection rate (10%), followed by surgical procedures below the knee (6.92%), while those performed on the face had a low rate (0.81%). “Based on their analysis, they suggest antibiotic prophylaxis for all procedures below the knee and groin, wedge excisions of the lip and ear, and all skin grafts,” Dr. Hata said.

In 2008, an advisory statement published in the Journal of the American Academy of Dermatology expanded the procedure location and techniques requiring antibiotic prophylaxis to include procedures on the nose and the lower extremity (especially the leg), and for patients with extensive inflammatory disease. According to the statement, in patients without a penicillin allergy, the suggested antibiotic prophylaxis regimen for wedge excision of the lip/ear, flaps on the nose, or all skin grafts include 2 g oral cephalexin or dicloxacillin. In patients with penicillin allergy, the recommended prophylaxis regimen for wedge excision of the lip/ear, flaps on the nose, or all skin grafts include 600 mg oral clindamycin or 500 mg oral azithromycin/clarithromycin.

In the statement, for patients with no penicillin allergy, the suggested prophylaxis regimen for lesions in the groin or on the lower extremities include 2 g oral cephalexin, 1 tablet of oral trimethoprim/sulfamethoxazole (TMP-SMX) DS, or 500 mg of levofloxacin. In patients with penicillin allergy, the recommended prophylaxis regimen for lesions on the groin and lower extremities is 1 tablet of TMP-SMX DS or 500 mg of levofloxacin.

In 2020, a meta-analysis of surgical site infections in patients undergoing Mohs surgery of the ear and nose found that there was no difference in infections in those locations whether patients received oral antibiotic prophylaxis or not. “But the researchers did not specify the type of closure, whether it was a graft or a flap closure,” Dr. Hata commented.


Endocarditis prophylaxis

Dr. Hata also discussed antibiotic recommendations for endocarditis prophylaxis, noting that the mortality rate from endocarditis is as high as 76%, and an estimated 40% of affected patients require heart valve replacement within 5-8 years. “But the good news is that fewer than 10 cases have been possibly linked to dermatologic procedures,” she said.

During outpatient dermatologic surgery, the incidence of bacteremia is in the range of 1.9%-3%, similar to the incidence of 2% that occurs spontaneously in healthy adults, according to Dr. Hata. She said that the following activities or procedures pose a much higher risk of bacteremia: mastication (17%-24%), tooth brushing (24%-40%), tooth extraction (60%-90%), and incision and drainage of an abscess (38%).

American Heart Association guidelines from 2007 recommend antibiotic prophylaxis in only the highest-risk categories of patients. These guidelines were updated in 2017 to include patients with transcatheter prosthetic valves and those with prosthetic material in valve repair. “The primary reason for revision of guidelines is that endocarditis is much more likely to result from frequent exposure to random bacteremia associated with daily activity such as brushing our teeth or having a tooth extracted,” Dr. Hata explained. “Prophylaxis may prevent an exceedingly small number of cases. Authors of the guidelines concluded that the risk of antibiotic-associated adverse event exceeds the benefit of prophylactic therapy, and that maintenance of optimal oral health is more important than prophylactic antibiotics.”

The 2017 AHA guidelines recommend antibiotic prophylaxis in patients with the following cardiac conditions: those with a prosthetic cardiac valve including transcatheter-implanted prostheses and homografts; those with previous endocarditis; those with prosthetic material used for heart valve repair, such as annuloplasty rings, chords or clips; cardiac transplantation recipients who develop cardiac valvulopathy; and those with certain types of congenital heart disease, including unrepaired cyanotic CHD, a completely repaired congenital heart defect with a prosthetic material or device during the first 6 months after the procedure, and repaired CHD with residual defects at the site or adjacent to the site of a prosthetic patch or prosthetic device.

Procedures that may require prophylaxis for endocarditis include all dental procedures that involve manipulation of the gingival tissue or the periapical region of teeth or perforation of the oral mucosa, and respiratory tract procedures that involve incision or biopsy of the respiratory mucosa such as tonsillectomy or adenoidectomy. Antibiotic prophylaxis is not recommended for procedures involving the gastrointestinal tract or the genitourinary tract unless an active infection is present. As for skin procedures, the guidelines recommend antibiotic prophylaxis for patients in the high-risk category who undergo a surgical procedure that involves infected skin, skin structure, or musculoskeletal tissue.

In the 2017 AHA guidelines, patients with no penicillin allergy, the suggested antibiotic prophylaxis regimen for endocarditis in non-oral sites includes 2 g oral cephalexin or dicloxacillin, while in patients with penicillin allergy, the suggested prophylaxis for endocarditis in non-oral sites includes 600 mg oral clindamycin or 500 mg oral azithromycin/clarithromycin. In patients without a penicillin allergy, the suggested prophylaxis for endocarditis in oral sites is 2 g oral amoxicillin, while in those with penicillin allergy, the suggested antibiotic prophylaxis for endocarditis in oral sites is 500 mg azithromycin/clarithromycin or doxycycline 100 mg.

“Antibiotic prophylaxis for endocarditis should be given 30-60 minutes prior to surgery, and a follow-up dose of antibiotics is no longer recommended,” Dr. Hata said. “If you forget [to administer the antibiotics] or the patient forgets, antibiotics may be given up to 2 hours after the procedure.”

Dr. Hata reported having no relevant disclosures.

Publications
Publications
Topics
Article Type
Sections
Article Source

AT A CONFERENCE ON SUPERFICIAL ANATOMY AND CUTANEOUS SURGERY

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Atopic dermatitis may be a risk factor for GBS colonization in pregnancy

Article Type
Changed
Fri, 08/25/2023 - 09:07

Pregnant women with atopic dermatitis (AD) are more likely to be colonized with group B streptococcus (GBS), compared with other pregnant women, results from a large cross-sectional study suggest.

“The rate of GBS colonization among pregnant females with a history of AD has not been previously reported, but AD could be a risk factor for maternal carriage of GBS,” corresponding author David J. Margolis, MD, PhD, of the department of dermatology at the University of Pennsylvania, Philadelphia, and colleagues wrote in the study, which was published as a letter to the editor online in the Journal of Investigative Dermatology. “GBS reporting in a large administrative database represents a unique opportunity to conduct a population-based evaluation of GBS carriage with AD. Understanding this association could expand our understanding of microbial changes associated with AD,” they noted.

To determine if an association between GBS and AD in pregnant women exists, the researchers performed a cross-sectional study using a random sample from an Optum administrative database of pregnant women who had vaginal deliveries between May of 2007 and September 2021. The primary outcome of interest was the presence of GBS based on American College of Obstetricians and Gynecologists–recommended codes for GBS during 36 0/7 to 37 6/7 weeks of pregnancy. They used descriptive statistics to summarize categorical and continuous variables as proportions and means, and logistic regression to examine the association between AD and GBS status.

The cohort included 566,467 pregnant women with an average age of 38.8 years. Of these, 2.9% had a diagnosis of AD or a history of AD, and 24.9% had diagnoses of asthma, seasonal allergies, or both. Women with AD had an increased odds ratio of asthma (OR, 2.55), seasonal allergies (OR, 3.39), or both (OR, 5.35), compared with those without AD.

GBS was reported in 20.6% of the cohort. The median time of follow-up for those with and without GBS was 494 days and 468 days, respectively (P = .134). Among the women with AD, 24.1% had GBS, compared with 20.51% of the women without AD (P <.0001), which translated into an OR of 1.23 (95% confidence interval, 1.18-1.27).

Among the women with GBS, the OR of asthma was 1.08 (95% CI, 1.06-1.10) and was 1.07 (95% CI, 1.05-1.09) among those with seasonal allergies. When adjusted for potential confounders, these findings did not change substantively.



“It is not apparent why pregnant females with AD are more likely to specifically carry GBS,” the authors wrote. “However, several studies have shown that individuals with AD are more likely to carry [Staphylococcus] aureus and that individuals with AD might be deficient in host defenses against S. aureus and other pathogens,” they added.

“Individuals with AD frequently receive antibiotics as part of their AD treatment and this might alter their resident microbiome. Carriage rates may be enhanced by the inhibition of an important barrier protein called filaggrin (FLG) and FLG loss of function genetic variation is known to decrease barrier proteins thought to inhibit the colonization of S. aureus and other pathogens,” the researchers wrote.

They acknowledged certain limitations of their study, including its reliance on an administrative database that does not contain information on past disease.

Asked to comment on the results, Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, who was not involved with the study, characterized AD as “the poster child for cutaneous dysbiosis – an altered petri dish, so to speak, [that] facilitates survival of the few, leading to decreased microbial diversity that can both enable potential pathogen invasion and immune dysregulation.”

Though it’s not surprising that pregnant AD patients have dysbiosis, the focus on GBS, “which can be a bad actor in the perinatal period, is an interesting connection,” he said. “Will this change practices? Pregnant women should be screened for GBS regardless, but maybe more attention or counseling can be offered to AD patients about the importance of screening. Would decolonization regimens be employed early in pregnancy? This study can’t answer that but certainly raises good questions.”

Dr. Margolis disclosed that he is or recently has been a consultant for Pfizer, Leo, and Sanofi with respect to studies of atopic dermatitis and served on an advisory board for the National Eczema Association. Another author disclosed receiving grants from companies related to work with AD; other authors had no disclosures. Dr. Friedman reported having no relevant disclosures.

Publications
Topics
Sections

Pregnant women with atopic dermatitis (AD) are more likely to be colonized with group B streptococcus (GBS), compared with other pregnant women, results from a large cross-sectional study suggest.

“The rate of GBS colonization among pregnant females with a history of AD has not been previously reported, but AD could be a risk factor for maternal carriage of GBS,” corresponding author David J. Margolis, MD, PhD, of the department of dermatology at the University of Pennsylvania, Philadelphia, and colleagues wrote in the study, which was published as a letter to the editor online in the Journal of Investigative Dermatology. “GBS reporting in a large administrative database represents a unique opportunity to conduct a population-based evaluation of GBS carriage with AD. Understanding this association could expand our understanding of microbial changes associated with AD,” they noted.

To determine if an association between GBS and AD in pregnant women exists, the researchers performed a cross-sectional study using a random sample from an Optum administrative database of pregnant women who had vaginal deliveries between May of 2007 and September 2021. The primary outcome of interest was the presence of GBS based on American College of Obstetricians and Gynecologists–recommended codes for GBS during 36 0/7 to 37 6/7 weeks of pregnancy. They used descriptive statistics to summarize categorical and continuous variables as proportions and means, and logistic regression to examine the association between AD and GBS status.

The cohort included 566,467 pregnant women with an average age of 38.8 years. Of these, 2.9% had a diagnosis of AD or a history of AD, and 24.9% had diagnoses of asthma, seasonal allergies, or both. Women with AD had an increased odds ratio of asthma (OR, 2.55), seasonal allergies (OR, 3.39), or both (OR, 5.35), compared with those without AD.

GBS was reported in 20.6% of the cohort. The median time of follow-up for those with and without GBS was 494 days and 468 days, respectively (P = .134). Among the women with AD, 24.1% had GBS, compared with 20.51% of the women without AD (P <.0001), which translated into an OR of 1.23 (95% confidence interval, 1.18-1.27).

Among the women with GBS, the OR of asthma was 1.08 (95% CI, 1.06-1.10) and was 1.07 (95% CI, 1.05-1.09) among those with seasonal allergies. When adjusted for potential confounders, these findings did not change substantively.



“It is not apparent why pregnant females with AD are more likely to specifically carry GBS,” the authors wrote. “However, several studies have shown that individuals with AD are more likely to carry [Staphylococcus] aureus and that individuals with AD might be deficient in host defenses against S. aureus and other pathogens,” they added.

“Individuals with AD frequently receive antibiotics as part of their AD treatment and this might alter their resident microbiome. Carriage rates may be enhanced by the inhibition of an important barrier protein called filaggrin (FLG) and FLG loss of function genetic variation is known to decrease barrier proteins thought to inhibit the colonization of S. aureus and other pathogens,” the researchers wrote.

They acknowledged certain limitations of their study, including its reliance on an administrative database that does not contain information on past disease.

Asked to comment on the results, Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, who was not involved with the study, characterized AD as “the poster child for cutaneous dysbiosis – an altered petri dish, so to speak, [that] facilitates survival of the few, leading to decreased microbial diversity that can both enable potential pathogen invasion and immune dysregulation.”

Though it’s not surprising that pregnant AD patients have dysbiosis, the focus on GBS, “which can be a bad actor in the perinatal period, is an interesting connection,” he said. “Will this change practices? Pregnant women should be screened for GBS regardless, but maybe more attention or counseling can be offered to AD patients about the importance of screening. Would decolonization regimens be employed early in pregnancy? This study can’t answer that but certainly raises good questions.”

Dr. Margolis disclosed that he is or recently has been a consultant for Pfizer, Leo, and Sanofi with respect to studies of atopic dermatitis and served on an advisory board for the National Eczema Association. Another author disclosed receiving grants from companies related to work with AD; other authors had no disclosures. Dr. Friedman reported having no relevant disclosures.

Pregnant women with atopic dermatitis (AD) are more likely to be colonized with group B streptococcus (GBS), compared with other pregnant women, results from a large cross-sectional study suggest.

“The rate of GBS colonization among pregnant females with a history of AD has not been previously reported, but AD could be a risk factor for maternal carriage of GBS,” corresponding author David J. Margolis, MD, PhD, of the department of dermatology at the University of Pennsylvania, Philadelphia, and colleagues wrote in the study, which was published as a letter to the editor online in the Journal of Investigative Dermatology. “GBS reporting in a large administrative database represents a unique opportunity to conduct a population-based evaluation of GBS carriage with AD. Understanding this association could expand our understanding of microbial changes associated with AD,” they noted.

To determine if an association between GBS and AD in pregnant women exists, the researchers performed a cross-sectional study using a random sample from an Optum administrative database of pregnant women who had vaginal deliveries between May of 2007 and September 2021. The primary outcome of interest was the presence of GBS based on American College of Obstetricians and Gynecologists–recommended codes for GBS during 36 0/7 to 37 6/7 weeks of pregnancy. They used descriptive statistics to summarize categorical and continuous variables as proportions and means, and logistic regression to examine the association between AD and GBS status.

The cohort included 566,467 pregnant women with an average age of 38.8 years. Of these, 2.9% had a diagnosis of AD or a history of AD, and 24.9% had diagnoses of asthma, seasonal allergies, or both. Women with AD had an increased odds ratio of asthma (OR, 2.55), seasonal allergies (OR, 3.39), or both (OR, 5.35), compared with those without AD.

GBS was reported in 20.6% of the cohort. The median time of follow-up for those with and without GBS was 494 days and 468 days, respectively (P = .134). Among the women with AD, 24.1% had GBS, compared with 20.51% of the women without AD (P <.0001), which translated into an OR of 1.23 (95% confidence interval, 1.18-1.27).

Among the women with GBS, the OR of asthma was 1.08 (95% CI, 1.06-1.10) and was 1.07 (95% CI, 1.05-1.09) among those with seasonal allergies. When adjusted for potential confounders, these findings did not change substantively.



“It is not apparent why pregnant females with AD are more likely to specifically carry GBS,” the authors wrote. “However, several studies have shown that individuals with AD are more likely to carry [Staphylococcus] aureus and that individuals with AD might be deficient in host defenses against S. aureus and other pathogens,” they added.

“Individuals with AD frequently receive antibiotics as part of their AD treatment and this might alter their resident microbiome. Carriage rates may be enhanced by the inhibition of an important barrier protein called filaggrin (FLG) and FLG loss of function genetic variation is known to decrease barrier proteins thought to inhibit the colonization of S. aureus and other pathogens,” the researchers wrote.

They acknowledged certain limitations of their study, including its reliance on an administrative database that does not contain information on past disease.

Asked to comment on the results, Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, who was not involved with the study, characterized AD as “the poster child for cutaneous dysbiosis – an altered petri dish, so to speak, [that] facilitates survival of the few, leading to decreased microbial diversity that can both enable potential pathogen invasion and immune dysregulation.”

Though it’s not surprising that pregnant AD patients have dysbiosis, the focus on GBS, “which can be a bad actor in the perinatal period, is an interesting connection,” he said. “Will this change practices? Pregnant women should be screened for GBS regardless, but maybe more attention or counseling can be offered to AD patients about the importance of screening. Would decolonization regimens be employed early in pregnancy? This study can’t answer that but certainly raises good questions.”

Dr. Margolis disclosed that he is or recently has been a consultant for Pfizer, Leo, and Sanofi with respect to studies of atopic dermatitis and served on an advisory board for the National Eczema Association. Another author disclosed receiving grants from companies related to work with AD; other authors had no disclosures. Dr. Friedman reported having no relevant disclosures.

Publications
Publications
Topics
Article Type
Sections
Article Source

FROM THE JOURNAL OF INVESTIGATIVE DERMATOLOGY

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Mohs found to confer survival benefit in localized Merkel cell carcinoma

Article Type
Changed
Thu, 08/24/2023 - 15:11

Mohs micrographic surgery (MMS) may be more effective than wide local excision (WLE) as a surgical treatment for localized T1/T2 Merkel cell carcinoma (MCC), results from a national retrospective cohort study suggest.

The study found that, in patients with pathologically confirmed, localized T1/T2 MCC, “treatment with MMS was associated with an approximately 40% reduction in hazard of death compared with WLE,” reported John A. Carucci, MD, PhD, and colleagues in the department of dermatology at NYU Langone Health, New York. The results provide “preliminary data suggesting that treatment of localized, early-stage MCC with MMS may result in the most optimal patient survival outcomes for this aggressive form of skin cancer,” they added. The study was published online in JAMA Dermatology.

“Although data for keratinocytic nonmelanoma skin cancers have been definitive in demonstrating the advantage of peripheral and deep en face margin assessment over conventional WLE or NME [narrow-margin excision], the data for MCC, likely because of the disease’s rarity and limitations of available data sets, have been mixed,” they wrote.

Results from national studies published in the Journal of the National Cancer Institute and the Journal of the American Academy of Dermatology found no difference in survival among patients with localized MCC treated with WLE versus MMS. “However, these studies did not have confirmed pathologic node status, a substantial limitation considering that clinically node-negative cases of localized MCC have sentinel lymph node positivity rates ranging from 25% to 40%,” the authors noted.

To evaluate the association of the surgical excision modality and patient survival for pathologically confirmed localized T1/T2 MCC, Dr. Carucci and coauthors examined a cohort of 2,313 patients from the National Cancer Database with T1/T2 MCC diagnosed between Jan. 1, 2004, and Dec. 31, 2018, with pathologically confirmed, negative regional lymph nodes and treated with surgery. Their mean age was 71 years and 57.9% were male. Of the 2,313 patients, 1,452 underwent WLE, 104 underwent MMS, and 757 underwent NME.

The unadjusted analysis revealed that, compared with WLE, excision with MMS had the best unadjusted mean survival rates: 87.4% versus 86.1%, respectively, at 3 years, 84.5% versus 76.9% at 5 years, and 81.8% versus 60.9% at 10 years. Patients treated with NME had similar mean survival rates as those treated with WLE: 84.8% at 3 years, 78.3% at 5 years, and 60.8% at 10 years.



Multivariable survival analysis demonstrated that treatment with MMS was associated with significantly improved survival, compared with WLE (hazard ratio, 0.59; 95% CI, 0.36-0.97; P = .04).

“These data suggest that MMS may provide a survival benefit in the treatment of localized MCC, although further prospective work studying this issue is required,” the authors concluded. “Future directions may also focus on elucidating the benefit of adjuvant radiotherapy in localized cases treated with MMS.”

They acknowledged certain limitations of the study, including the fewer numbers of patients receiving MMS surgery, lack of randomization, and potential for selection bias.

In an interview, Travis W. Blalock, MD, director of dermatologic surgery, Mohs micrographic surgery, and cutaneous oncology at Emory University, Atlanta, who was asked to comment on the study, said that the field of MCC “has undergone rapid and robust transformation over the past 20 years. These changes encompass advancements in diagnosing the condition, identifying linked viruses, and developing systemic treatments.”

The study findings “imply that comprehensive assessment of histologic margins might offer advantages beyond minimizing scars, minimizing functional impact, and reducing the likelihood of local recurrence,” he said.

“It’s beyond doubt,” he added, that the study “furnishes us with yet another set of real-world insights that will undoubtedly influence patient outcomes. These insights serve to bring clarity to the ways in which we can deliver precisely targeted surgical treatment with durable outcomes for localized MCC.”

Patricia M. Richey, MD, director of Mohs surgery at Boston University, who was also asked to comment on the study, added that, because of the nature of the National Cancer Database, “the authors of this study were unfortunately unable to report disease-specific survival or immunosuppression status. That being said, the preliminary data presented are convincing and should result in us further exploring this topic, as well as readdressing and questioning related issues such as whether or not adjuvant radiotherapy is truly beneficial in cases with histologic clearance via Mohs.”

Dr. Carucci reported receiving grant funding from Regeneron for investigator-initiated basic research. No other author disclosures were reported. Neither Dr. Blalock nor Dr. Richey had relevant disclosures.

Publications
Topics
Sections

Mohs micrographic surgery (MMS) may be more effective than wide local excision (WLE) as a surgical treatment for localized T1/T2 Merkel cell carcinoma (MCC), results from a national retrospective cohort study suggest.

The study found that, in patients with pathologically confirmed, localized T1/T2 MCC, “treatment with MMS was associated with an approximately 40% reduction in hazard of death compared with WLE,” reported John A. Carucci, MD, PhD, and colleagues in the department of dermatology at NYU Langone Health, New York. The results provide “preliminary data suggesting that treatment of localized, early-stage MCC with MMS may result in the most optimal patient survival outcomes for this aggressive form of skin cancer,” they added. The study was published online in JAMA Dermatology.

“Although data for keratinocytic nonmelanoma skin cancers have been definitive in demonstrating the advantage of peripheral and deep en face margin assessment over conventional WLE or NME [narrow-margin excision], the data for MCC, likely because of the disease’s rarity and limitations of available data sets, have been mixed,” they wrote.

Results from national studies published in the Journal of the National Cancer Institute and the Journal of the American Academy of Dermatology found no difference in survival among patients with localized MCC treated with WLE versus MMS. “However, these studies did not have confirmed pathologic node status, a substantial limitation considering that clinically node-negative cases of localized MCC have sentinel lymph node positivity rates ranging from 25% to 40%,” the authors noted.

To evaluate the association of the surgical excision modality and patient survival for pathologically confirmed localized T1/T2 MCC, Dr. Carucci and coauthors examined a cohort of 2,313 patients from the National Cancer Database with T1/T2 MCC diagnosed between Jan. 1, 2004, and Dec. 31, 2018, with pathologically confirmed, negative regional lymph nodes and treated with surgery. Their mean age was 71 years and 57.9% were male. Of the 2,313 patients, 1,452 underwent WLE, 104 underwent MMS, and 757 underwent NME.

The unadjusted analysis revealed that, compared with WLE, excision with MMS had the best unadjusted mean survival rates: 87.4% versus 86.1%, respectively, at 3 years, 84.5% versus 76.9% at 5 years, and 81.8% versus 60.9% at 10 years. Patients treated with NME had similar mean survival rates as those treated with WLE: 84.8% at 3 years, 78.3% at 5 years, and 60.8% at 10 years.



Multivariable survival analysis demonstrated that treatment with MMS was associated with significantly improved survival, compared with WLE (hazard ratio, 0.59; 95% CI, 0.36-0.97; P = .04).

“These data suggest that MMS may provide a survival benefit in the treatment of localized MCC, although further prospective work studying this issue is required,” the authors concluded. “Future directions may also focus on elucidating the benefit of adjuvant radiotherapy in localized cases treated with MMS.”

They acknowledged certain limitations of the study, including the fewer numbers of patients receiving MMS surgery, lack of randomization, and potential for selection bias.

In an interview, Travis W. Blalock, MD, director of dermatologic surgery, Mohs micrographic surgery, and cutaneous oncology at Emory University, Atlanta, who was asked to comment on the study, said that the field of MCC “has undergone rapid and robust transformation over the past 20 years. These changes encompass advancements in diagnosing the condition, identifying linked viruses, and developing systemic treatments.”

The study findings “imply that comprehensive assessment of histologic margins might offer advantages beyond minimizing scars, minimizing functional impact, and reducing the likelihood of local recurrence,” he said.

“It’s beyond doubt,” he added, that the study “furnishes us with yet another set of real-world insights that will undoubtedly influence patient outcomes. These insights serve to bring clarity to the ways in which we can deliver precisely targeted surgical treatment with durable outcomes for localized MCC.”

Patricia M. Richey, MD, director of Mohs surgery at Boston University, who was also asked to comment on the study, added that, because of the nature of the National Cancer Database, “the authors of this study were unfortunately unable to report disease-specific survival or immunosuppression status. That being said, the preliminary data presented are convincing and should result in us further exploring this topic, as well as readdressing and questioning related issues such as whether or not adjuvant radiotherapy is truly beneficial in cases with histologic clearance via Mohs.”

Dr. Carucci reported receiving grant funding from Regeneron for investigator-initiated basic research. No other author disclosures were reported. Neither Dr. Blalock nor Dr. Richey had relevant disclosures.

Mohs micrographic surgery (MMS) may be more effective than wide local excision (WLE) as a surgical treatment for localized T1/T2 Merkel cell carcinoma (MCC), results from a national retrospective cohort study suggest.

The study found that, in patients with pathologically confirmed, localized T1/T2 MCC, “treatment with MMS was associated with an approximately 40% reduction in hazard of death compared with WLE,” reported John A. Carucci, MD, PhD, and colleagues in the department of dermatology at NYU Langone Health, New York. The results provide “preliminary data suggesting that treatment of localized, early-stage MCC with MMS may result in the most optimal patient survival outcomes for this aggressive form of skin cancer,” they added. The study was published online in JAMA Dermatology.

“Although data for keratinocytic nonmelanoma skin cancers have been definitive in demonstrating the advantage of peripheral and deep en face margin assessment over conventional WLE or NME [narrow-margin excision], the data for MCC, likely because of the disease’s rarity and limitations of available data sets, have been mixed,” they wrote.

Results from national studies published in the Journal of the National Cancer Institute and the Journal of the American Academy of Dermatology found no difference in survival among patients with localized MCC treated with WLE versus MMS. “However, these studies did not have confirmed pathologic node status, a substantial limitation considering that clinically node-negative cases of localized MCC have sentinel lymph node positivity rates ranging from 25% to 40%,” the authors noted.

To evaluate the association of the surgical excision modality and patient survival for pathologically confirmed localized T1/T2 MCC, Dr. Carucci and coauthors examined a cohort of 2,313 patients from the National Cancer Database with T1/T2 MCC diagnosed between Jan. 1, 2004, and Dec. 31, 2018, with pathologically confirmed, negative regional lymph nodes and treated with surgery. Their mean age was 71 years and 57.9% were male. Of the 2,313 patients, 1,452 underwent WLE, 104 underwent MMS, and 757 underwent NME.

The unadjusted analysis revealed that, compared with WLE, excision with MMS had the best unadjusted mean survival rates: 87.4% versus 86.1%, respectively, at 3 years, 84.5% versus 76.9% at 5 years, and 81.8% versus 60.9% at 10 years. Patients treated with NME had similar mean survival rates as those treated with WLE: 84.8% at 3 years, 78.3% at 5 years, and 60.8% at 10 years.



Multivariable survival analysis demonstrated that treatment with MMS was associated with significantly improved survival, compared with WLE (hazard ratio, 0.59; 95% CI, 0.36-0.97; P = .04).

“These data suggest that MMS may provide a survival benefit in the treatment of localized MCC, although further prospective work studying this issue is required,” the authors concluded. “Future directions may also focus on elucidating the benefit of adjuvant radiotherapy in localized cases treated with MMS.”

They acknowledged certain limitations of the study, including the fewer numbers of patients receiving MMS surgery, lack of randomization, and potential for selection bias.

In an interview, Travis W. Blalock, MD, director of dermatologic surgery, Mohs micrographic surgery, and cutaneous oncology at Emory University, Atlanta, who was asked to comment on the study, said that the field of MCC “has undergone rapid and robust transformation over the past 20 years. These changes encompass advancements in diagnosing the condition, identifying linked viruses, and developing systemic treatments.”

The study findings “imply that comprehensive assessment of histologic margins might offer advantages beyond minimizing scars, minimizing functional impact, and reducing the likelihood of local recurrence,” he said.

“It’s beyond doubt,” he added, that the study “furnishes us with yet another set of real-world insights that will undoubtedly influence patient outcomes. These insights serve to bring clarity to the ways in which we can deliver precisely targeted surgical treatment with durable outcomes for localized MCC.”

Patricia M. Richey, MD, director of Mohs surgery at Boston University, who was also asked to comment on the study, added that, because of the nature of the National Cancer Database, “the authors of this study were unfortunately unable to report disease-specific survival or immunosuppression status. That being said, the preliminary data presented are convincing and should result in us further exploring this topic, as well as readdressing and questioning related issues such as whether or not adjuvant radiotherapy is truly beneficial in cases with histologic clearance via Mohs.”

Dr. Carucci reported receiving grant funding from Regeneron for investigator-initiated basic research. No other author disclosures were reported. Neither Dr. Blalock nor Dr. Richey had relevant disclosures.

Publications
Publications
Topics
Article Type
Sections
Article Source

FROM JAMA DERMATOLOGY

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article