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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.
Obtaining cystatin-C levels useful in chronic kidney disease
SAN FRANCISCO – Routine lab tests for estimating the average glomerular filtration rate (GFR) are too imprecise, according to Michael G. Shlipak, MD.
“If you study 100 patients, the average GFR based on creatinine is going to be pretty close to estimated GFR,” Dr. Shlipak said at the UCSF Annual Advances in Internal Medicine meeting. “But with individual patients, the average GFR is going to be plus or minus 30%, which is a lot. If the estimated GFR is 70 mL/min per 1.73 m2, the real GFR could be between 50 and 90 mL/min per 1.73 m2; so that’s a wide range.”
“The main appeal of the Cockcroft-Gault equation is that you can almost do it in your head, so that’s a real positive,” said Dr. Shlipak, who is also scientific director of the Kidney Health Research Collaborative at the University of California, San Francisco, and professor of internal medicine, epidemiology, and biostatistics at UCSF Medical Center. “The main disadvantage is that it’s really a terrible equation. The Cockcroft-Gault equation is clearly inadequate, as it is standardized to creatinine clearance and very inaccurate, so it should no longer be used. The MDRD and the CKD-EPI are newer equations that are at least validated to real GFR and not creatinine clearance. In our system, the pharmacy uses the Cockcroft-Gault equation, and the lab gives us the MDRD GFR equation, so it’s quite confusing.”
Dr. Shlipak described using estimated GFR in clinical decision making as “better than using just creatinine, because it integrates demographic characteristics, which are determinants in part of the creatinine production, which is what determines how much creatinine is in the blood before it gets filtered. The equations make us think of GFR and kidney function instead of just the lab value.”
The downsides of using GFRs, he added, include the fact that they are mostly validated in younger patients with kidney disease, they rely on the assumption that demographic characteristics alone can define muscle mass, they were only developed in whites and blacks, and estimated GFR can be interpreted only as “suggested GFR.”
A blood test of kidney function known as cystatin C has been shown to be an alternative, better marker of creatinine, compared with GFR, and is supported by the Kidney Disease: Improving Global Outcomes CKD work group’s 2012 clinical practice guidelines for the evaluation and management of CKD. “Because cystatin C is not related to muscle mass, age, sex, and race, it has major advantages over creatinine,” Dr. Shlipak said. “It is a reliable, standardized, and automated measure that is available for clinical use.”
He and his associates conducted a meta-analysis comparing cystatin C and creatinine in determining prognosis for patients with baseline kidney disease. They included 16 studies involving 90,750 patients and compared associations of estimated GFR (eGFR) as measured with creatinine, cystatin C, and both creatinine and cystatin C with mortality risk; they also determined proportions reclassified by cystatin C in each subgroup of eGFR using creatinine and by the effect on risk associations (N Engl J Med. 2013 Sep 5; 369[10]:932-43).
In the general-population cohorts, the prevalence of an eGFR of less than 60 mL/min per 1.73 m2 of body surface area was higher with the cystatin C–based eGFR than with the creatinine-based eGFR (13.7% vs. 9.7%). Across all eGFR categories, the reclassification of the eGFR to a higher value with the measurement of cystatin C, compared with creatinine, was associated with a reduced risk of all three study outcomes. Reclassification to a lower eGFR was associated with an increased risk.
“When we looked at the threshold for where risk begins, traditionally we’ve said it starts when the GFR declines below 60 mL/min per 1.73 m2,” Dr. Shlipak explained. “That’s exactly what we found with creatinine. But with cystatin C, the threshold of risk was at 88 mL/min per 1.73 m2.
“So, from 88 mL/min per 1.73 m2 downward, every incremental reduction in GFR is associated with higher mortality and cardiovascular risk,” he added. “So cystatin C opens this new window of between 60 and 90 mL/min per 1.73 m2 to start measuring relative declines in kidney function. If you combine creatinine and cystatin C together in an equation, you get a similar estimate. Many advocate that the combined CKD-EPI creatinine-cystatin C equation is the best way to measure GFR.”
Dr. Shlipak reported that he is on the scientific advisory boards of TAI Diagnostics and Cricket Health.
SAN FRANCISCO – Routine lab tests for estimating the average glomerular filtration rate (GFR) are too imprecise, according to Michael G. Shlipak, MD.
“If you study 100 patients, the average GFR based on creatinine is going to be pretty close to estimated GFR,” Dr. Shlipak said at the UCSF Annual Advances in Internal Medicine meeting. “But with individual patients, the average GFR is going to be plus or minus 30%, which is a lot. If the estimated GFR is 70 mL/min per 1.73 m2, the real GFR could be between 50 and 90 mL/min per 1.73 m2; so that’s a wide range.”
“The main appeal of the Cockcroft-Gault equation is that you can almost do it in your head, so that’s a real positive,” said Dr. Shlipak, who is also scientific director of the Kidney Health Research Collaborative at the University of California, San Francisco, and professor of internal medicine, epidemiology, and biostatistics at UCSF Medical Center. “The main disadvantage is that it’s really a terrible equation. The Cockcroft-Gault equation is clearly inadequate, as it is standardized to creatinine clearance and very inaccurate, so it should no longer be used. The MDRD and the CKD-EPI are newer equations that are at least validated to real GFR and not creatinine clearance. In our system, the pharmacy uses the Cockcroft-Gault equation, and the lab gives us the MDRD GFR equation, so it’s quite confusing.”
Dr. Shlipak described using estimated GFR in clinical decision making as “better than using just creatinine, because it integrates demographic characteristics, which are determinants in part of the creatinine production, which is what determines how much creatinine is in the blood before it gets filtered. The equations make us think of GFR and kidney function instead of just the lab value.”
The downsides of using GFRs, he added, include the fact that they are mostly validated in younger patients with kidney disease, they rely on the assumption that demographic characteristics alone can define muscle mass, they were only developed in whites and blacks, and estimated GFR can be interpreted only as “suggested GFR.”
A blood test of kidney function known as cystatin C has been shown to be an alternative, better marker of creatinine, compared with GFR, and is supported by the Kidney Disease: Improving Global Outcomes CKD work group’s 2012 clinical practice guidelines for the evaluation and management of CKD. “Because cystatin C is not related to muscle mass, age, sex, and race, it has major advantages over creatinine,” Dr. Shlipak said. “It is a reliable, standardized, and automated measure that is available for clinical use.”
He and his associates conducted a meta-analysis comparing cystatin C and creatinine in determining prognosis for patients with baseline kidney disease. They included 16 studies involving 90,750 patients and compared associations of estimated GFR (eGFR) as measured with creatinine, cystatin C, and both creatinine and cystatin C with mortality risk; they also determined proportions reclassified by cystatin C in each subgroup of eGFR using creatinine and by the effect on risk associations (N Engl J Med. 2013 Sep 5; 369[10]:932-43).
In the general-population cohorts, the prevalence of an eGFR of less than 60 mL/min per 1.73 m2 of body surface area was higher with the cystatin C–based eGFR than with the creatinine-based eGFR (13.7% vs. 9.7%). Across all eGFR categories, the reclassification of the eGFR to a higher value with the measurement of cystatin C, compared with creatinine, was associated with a reduced risk of all three study outcomes. Reclassification to a lower eGFR was associated with an increased risk.
“When we looked at the threshold for where risk begins, traditionally we’ve said it starts when the GFR declines below 60 mL/min per 1.73 m2,” Dr. Shlipak explained. “That’s exactly what we found with creatinine. But with cystatin C, the threshold of risk was at 88 mL/min per 1.73 m2.
“So, from 88 mL/min per 1.73 m2 downward, every incremental reduction in GFR is associated with higher mortality and cardiovascular risk,” he added. “So cystatin C opens this new window of between 60 and 90 mL/min per 1.73 m2 to start measuring relative declines in kidney function. If you combine creatinine and cystatin C together in an equation, you get a similar estimate. Many advocate that the combined CKD-EPI creatinine-cystatin C equation is the best way to measure GFR.”
Dr. Shlipak reported that he is on the scientific advisory boards of TAI Diagnostics and Cricket Health.
SAN FRANCISCO – Routine lab tests for estimating the average glomerular filtration rate (GFR) are too imprecise, according to Michael G. Shlipak, MD.
“If you study 100 patients, the average GFR based on creatinine is going to be pretty close to estimated GFR,” Dr. Shlipak said at the UCSF Annual Advances in Internal Medicine meeting. “But with individual patients, the average GFR is going to be plus or minus 30%, which is a lot. If the estimated GFR is 70 mL/min per 1.73 m2, the real GFR could be between 50 and 90 mL/min per 1.73 m2; so that’s a wide range.”
“The main appeal of the Cockcroft-Gault equation is that you can almost do it in your head, so that’s a real positive,” said Dr. Shlipak, who is also scientific director of the Kidney Health Research Collaborative at the University of California, San Francisco, and professor of internal medicine, epidemiology, and biostatistics at UCSF Medical Center. “The main disadvantage is that it’s really a terrible equation. The Cockcroft-Gault equation is clearly inadequate, as it is standardized to creatinine clearance and very inaccurate, so it should no longer be used. The MDRD and the CKD-EPI are newer equations that are at least validated to real GFR and not creatinine clearance. In our system, the pharmacy uses the Cockcroft-Gault equation, and the lab gives us the MDRD GFR equation, so it’s quite confusing.”
Dr. Shlipak described using estimated GFR in clinical decision making as “better than using just creatinine, because it integrates demographic characteristics, which are determinants in part of the creatinine production, which is what determines how much creatinine is in the blood before it gets filtered. The equations make us think of GFR and kidney function instead of just the lab value.”
The downsides of using GFRs, he added, include the fact that they are mostly validated in younger patients with kidney disease, they rely on the assumption that demographic characteristics alone can define muscle mass, they were only developed in whites and blacks, and estimated GFR can be interpreted only as “suggested GFR.”
A blood test of kidney function known as cystatin C has been shown to be an alternative, better marker of creatinine, compared with GFR, and is supported by the Kidney Disease: Improving Global Outcomes CKD work group’s 2012 clinical practice guidelines for the evaluation and management of CKD. “Because cystatin C is not related to muscle mass, age, sex, and race, it has major advantages over creatinine,” Dr. Shlipak said. “It is a reliable, standardized, and automated measure that is available for clinical use.”
He and his associates conducted a meta-analysis comparing cystatin C and creatinine in determining prognosis for patients with baseline kidney disease. They included 16 studies involving 90,750 patients and compared associations of estimated GFR (eGFR) as measured with creatinine, cystatin C, and both creatinine and cystatin C with mortality risk; they also determined proportions reclassified by cystatin C in each subgroup of eGFR using creatinine and by the effect on risk associations (N Engl J Med. 2013 Sep 5; 369[10]:932-43).
In the general-population cohorts, the prevalence of an eGFR of less than 60 mL/min per 1.73 m2 of body surface area was higher with the cystatin C–based eGFR than with the creatinine-based eGFR (13.7% vs. 9.7%). Across all eGFR categories, the reclassification of the eGFR to a higher value with the measurement of cystatin C, compared with creatinine, was associated with a reduced risk of all three study outcomes. Reclassification to a lower eGFR was associated with an increased risk.
“When we looked at the threshold for where risk begins, traditionally we’ve said it starts when the GFR declines below 60 mL/min per 1.73 m2,” Dr. Shlipak explained. “That’s exactly what we found with creatinine. But with cystatin C, the threshold of risk was at 88 mL/min per 1.73 m2.
“So, from 88 mL/min per 1.73 m2 downward, every incremental reduction in GFR is associated with higher mortality and cardiovascular risk,” he added. “So cystatin C opens this new window of between 60 and 90 mL/min per 1.73 m2 to start measuring relative declines in kidney function. If you combine creatinine and cystatin C together in an equation, you get a similar estimate. Many advocate that the combined CKD-EPI creatinine-cystatin C equation is the best way to measure GFR.”
Dr. Shlipak reported that he is on the scientific advisory boards of TAI Diagnostics and Cricket Health.
AT THE ANNUAL ADVANCES IN INTERNAL MEDICINE
Targeted therapy may be possible for pityriasis rubra pilaris
CHICAGO – If you’ve ever found that making a diagnosis of pityriasis rubra pilaris is difficult, you’re not alone.
In a recent case series of 100 patients with a median age of 61 years, only 50 patients had an undeniable diagnosis of pityriasis rubra pilaris (PRP). Of those patients, only 26% were diagnosed at initial presentation. The mean delay to diagnosis was 29 months, and 54% required two or more biopsies (JAMA Derm. 2016 Jun 1;152[6]:670-5).
“This is one of those conditions that sometimes you’re going to follow patients and not know what it is right away,” Patricia M. Witman, MD, said at the World Congress of Pediatric Dermatology. Although eczema and contact dermatitis are common diseases where the diagnosis is missed, it’s easy to mistake pityriasis rubra pilaris for psoriasis.
“On the flip side, follicular psoriasis is easy to mistake for PRP,” said Dr. Witman, chief of the division of dermatology at Nationwide Children’s Hospital, Columbus, Ohio. “It’s an uncommon variant that occurs in only about 2.1% of all pediatric psoriasis. These patients can have keratoderma, but they have classic psoriasis on biopsy. Pediatric patients with this subtype do not typically have classic psoriasis plaques.”
PRP is an anti-inflammatory papulosquamous disease with an incidence that ranges between 1:3,500 and 1:400,000. It occurs equally in men and women and has a bimodal onset, with 52%-60% of cases occurring in the 6th or 7th decade of life, and 6%-12% occurring in the 1st or 2nd decade of life, with a mean age of 7 years. Characteristic clinical features include cephalocaudal spread, keratotic follicular papules, well-demarcated orange/red plaques, fine scale, islands of sparing, erythroderma, and palmoplantar keratoderma.
“Even though it’s characteristic, there is a wide spread in the type of disease manifestations,” Dr. Witman said. “There are six different types based on how old you are and on the presentation.”
She limited her presentation to a discussion of three types:
- Classic juvenile type. This type usually presents between ages 5 and 10 and resembles the type I, or classic adult, type, with cephalocaudal spread, follicular keratotic erythematous papules coalescing into plaques, islands of sparing, and typically keratoderma. The scalp dermatitis it causes “often has a little finer scale than the thick micaceous scale we see in psoriasis,” she noted. “Patients can have a photoaggravated presentation with relative sparing of areas protected from the sun.”
- Circumscribed juvenile type. This is the most common pediatric variant. It usually presents between the ages of 3 and 10, with a mean age of 6. It is characterized by sharply demarcated plaques on extensor elbows and knees, as well as follicular hyperkeratosis. About 70% will also have keratoderma. “The Achilles tendon involvement is considered to be fairly pathognomonic for this condition and helps differentiate it from psoriasis, as well as an orange to yellow color of the keratoderma,” Dr. Witman said.
- The atypical juvenile type, or type V. This the familial variant of PRP. It’s also the rarest, occurring in just 6.5% of cases. “It’s autosomal dominant and has incomplete penetrance and variable expression,” she said. “It typically presents in infancy or in the first few years of life. Patients with this form also tend to have a more sclerodermoid palmoplantar keratoderma and ichthyosiform features. It is typically a lifelong condition, but there have been occasional case reports of self-resolution.”
The clinical features of PRP often overlap with psoriasis.
“Although there are some things that are more pathognomonic for PRP, like the Achilles tendon involvement and the keratoderma, for psoriasis we have nail pitting, which we don’t usually see in PRP,” Dr. Witman said. “Sometimes, it’s the skin biopsy that helps us distinguish those defining features, and it may take more than one biopsy to make the diagnosis.”
Dermoscopy can also be helpful. One analysis found that dermoscopy features of PRP include multiple keratotic papules with peripheral rings of erythema that coalesce into a yellow-orange plaque, linear vessels at the periphery of papules, and papules centered on hair (J Am Acad Dermatol. 2015 Jan;72[1]:S58-9).
“Even when you have that definite diagnosis of PRP, you have to remember that PRP can be seen within the context of other disease,” Dr. Witman cautioned. “Malignancy is usually limited to our adult patients with PRP, but infection can certainly trigger PRP in our pediatric patients, most commonly streptococcus. Medication reactions, especially to the biologics, have also been reported to cause PRP-like reactions, as well as autoimmune disease.”
One such entity is referred to as “Wong-like” dermatomyositis, in which patients present with a rash that looks identical to PRP (Ped Dermatol. 2007;24[2]:155-6). “It can occur in both the juvenile and adult populations,” she said. “It has clinical and histopathologic features of PRP, yet it may precede or occur concurrently with a diagnosis of dermatomyositis.”
In 2012, a group of researchers discovered that a gain of function mutation in CARD14 leads to atypical juvenile-type PRP (Am J Hum Genet. 2012 Jul 13;91:163-70). CARD14 is a member of a protein family known as caspase recruitment domain, family member 14, which also is mutated in a variant of familial psoriasis.
“It’s a protein that’s predominantly expressed in the skin, and it’s a known activator of transcription factor nuclear factor kappa light chain enhancer in activated B cells [NFkB], which is responsible for inflammation in the epidermis,” Dr. Witman explained. “What we know is that if you have a gain of function mutation in CARD14, we think that this activates the NFkB pathway and leads to increased inflammation of the skin. The same process would be expected in cases of familial psoriasis.”
Current treatment of PRP is challenging, he said. A recent survey of patients found that 76% found emollients most effective, followed by topical steroids (50%) and salicylic acid (45%) (JAMA Derm. 2016 Jun 1;152[6]:670-5). When it came to systemic therapies, 59% found retinoids most effective, followed by methotrexate (42%) and tumor necrosis factor inhibitors (40%). Only 8% found phototherapy helpful.
Dr. Witman noted that the discovery of the CARD14 mutation as the cause of the familial variant “brings us closer to an understanding of juvenile PRP,” and to the potential for targeted therapy.
“This really raises the question: Do ustekinumab and similar drugs have a future role in the treatment of PRP?” she asked. “We do see anecdotal evidence of clearance in adults using ustekinumab, both those with and without type V PRP and a CARD14 mutation. It has been tried in adult patients, predominantly in those who have failed multiple therapies. But this is anecdotal evidence with isolated case reports. These patients did respond to dosing that is typical for psoriasis.
“At this point, it is not approved for PRP, nor is it approved in children – but it’s something to think about once we have more information,” Dr. Witman noted. “The newer biologics targeting IL[interleukin]-23 and IL-17 may hold promise for PRP, based on what we have learned in psoriasis. But at this point, the safest and most effective therapy for the different variants of PRP in our pediatric patients remains to be seen.”
Dr. Witman reported having no relevant financial disclosures.
CHICAGO – If you’ve ever found that making a diagnosis of pityriasis rubra pilaris is difficult, you’re not alone.
In a recent case series of 100 patients with a median age of 61 years, only 50 patients had an undeniable diagnosis of pityriasis rubra pilaris (PRP). Of those patients, only 26% were diagnosed at initial presentation. The mean delay to diagnosis was 29 months, and 54% required two or more biopsies (JAMA Derm. 2016 Jun 1;152[6]:670-5).
“This is one of those conditions that sometimes you’re going to follow patients and not know what it is right away,” Patricia M. Witman, MD, said at the World Congress of Pediatric Dermatology. Although eczema and contact dermatitis are common diseases where the diagnosis is missed, it’s easy to mistake pityriasis rubra pilaris for psoriasis.
“On the flip side, follicular psoriasis is easy to mistake for PRP,” said Dr. Witman, chief of the division of dermatology at Nationwide Children’s Hospital, Columbus, Ohio. “It’s an uncommon variant that occurs in only about 2.1% of all pediatric psoriasis. These patients can have keratoderma, but they have classic psoriasis on biopsy. Pediatric patients with this subtype do not typically have classic psoriasis plaques.”
PRP is an anti-inflammatory papulosquamous disease with an incidence that ranges between 1:3,500 and 1:400,000. It occurs equally in men and women and has a bimodal onset, with 52%-60% of cases occurring in the 6th or 7th decade of life, and 6%-12% occurring in the 1st or 2nd decade of life, with a mean age of 7 years. Characteristic clinical features include cephalocaudal spread, keratotic follicular papules, well-demarcated orange/red plaques, fine scale, islands of sparing, erythroderma, and palmoplantar keratoderma.
“Even though it’s characteristic, there is a wide spread in the type of disease manifestations,” Dr. Witman said. “There are six different types based on how old you are and on the presentation.”
She limited her presentation to a discussion of three types:
- Classic juvenile type. This type usually presents between ages 5 and 10 and resembles the type I, or classic adult, type, with cephalocaudal spread, follicular keratotic erythematous papules coalescing into plaques, islands of sparing, and typically keratoderma. The scalp dermatitis it causes “often has a little finer scale than the thick micaceous scale we see in psoriasis,” she noted. “Patients can have a photoaggravated presentation with relative sparing of areas protected from the sun.”
- Circumscribed juvenile type. This is the most common pediatric variant. It usually presents between the ages of 3 and 10, with a mean age of 6. It is characterized by sharply demarcated plaques on extensor elbows and knees, as well as follicular hyperkeratosis. About 70% will also have keratoderma. “The Achilles tendon involvement is considered to be fairly pathognomonic for this condition and helps differentiate it from psoriasis, as well as an orange to yellow color of the keratoderma,” Dr. Witman said.
- The atypical juvenile type, or type V. This the familial variant of PRP. It’s also the rarest, occurring in just 6.5% of cases. “It’s autosomal dominant and has incomplete penetrance and variable expression,” she said. “It typically presents in infancy or in the first few years of life. Patients with this form also tend to have a more sclerodermoid palmoplantar keratoderma and ichthyosiform features. It is typically a lifelong condition, but there have been occasional case reports of self-resolution.”
The clinical features of PRP often overlap with psoriasis.
“Although there are some things that are more pathognomonic for PRP, like the Achilles tendon involvement and the keratoderma, for psoriasis we have nail pitting, which we don’t usually see in PRP,” Dr. Witman said. “Sometimes, it’s the skin biopsy that helps us distinguish those defining features, and it may take more than one biopsy to make the diagnosis.”
Dermoscopy can also be helpful. One analysis found that dermoscopy features of PRP include multiple keratotic papules with peripheral rings of erythema that coalesce into a yellow-orange plaque, linear vessels at the periphery of papules, and papules centered on hair (J Am Acad Dermatol. 2015 Jan;72[1]:S58-9).
“Even when you have that definite diagnosis of PRP, you have to remember that PRP can be seen within the context of other disease,” Dr. Witman cautioned. “Malignancy is usually limited to our adult patients with PRP, but infection can certainly trigger PRP in our pediatric patients, most commonly streptococcus. Medication reactions, especially to the biologics, have also been reported to cause PRP-like reactions, as well as autoimmune disease.”
One such entity is referred to as “Wong-like” dermatomyositis, in which patients present with a rash that looks identical to PRP (Ped Dermatol. 2007;24[2]:155-6). “It can occur in both the juvenile and adult populations,” she said. “It has clinical and histopathologic features of PRP, yet it may precede or occur concurrently with a diagnosis of dermatomyositis.”
In 2012, a group of researchers discovered that a gain of function mutation in CARD14 leads to atypical juvenile-type PRP (Am J Hum Genet. 2012 Jul 13;91:163-70). CARD14 is a member of a protein family known as caspase recruitment domain, family member 14, which also is mutated in a variant of familial psoriasis.
“It’s a protein that’s predominantly expressed in the skin, and it’s a known activator of transcription factor nuclear factor kappa light chain enhancer in activated B cells [NFkB], which is responsible for inflammation in the epidermis,” Dr. Witman explained. “What we know is that if you have a gain of function mutation in CARD14, we think that this activates the NFkB pathway and leads to increased inflammation of the skin. The same process would be expected in cases of familial psoriasis.”
Current treatment of PRP is challenging, he said. A recent survey of patients found that 76% found emollients most effective, followed by topical steroids (50%) and salicylic acid (45%) (JAMA Derm. 2016 Jun 1;152[6]:670-5). When it came to systemic therapies, 59% found retinoids most effective, followed by methotrexate (42%) and tumor necrosis factor inhibitors (40%). Only 8% found phototherapy helpful.
Dr. Witman noted that the discovery of the CARD14 mutation as the cause of the familial variant “brings us closer to an understanding of juvenile PRP,” and to the potential for targeted therapy.
“This really raises the question: Do ustekinumab and similar drugs have a future role in the treatment of PRP?” she asked. “We do see anecdotal evidence of clearance in adults using ustekinumab, both those with and without type V PRP and a CARD14 mutation. It has been tried in adult patients, predominantly in those who have failed multiple therapies. But this is anecdotal evidence with isolated case reports. These patients did respond to dosing that is typical for psoriasis.
“At this point, it is not approved for PRP, nor is it approved in children – but it’s something to think about once we have more information,” Dr. Witman noted. “The newer biologics targeting IL[interleukin]-23 and IL-17 may hold promise for PRP, based on what we have learned in psoriasis. But at this point, the safest and most effective therapy for the different variants of PRP in our pediatric patients remains to be seen.”
Dr. Witman reported having no relevant financial disclosures.
CHICAGO – If you’ve ever found that making a diagnosis of pityriasis rubra pilaris is difficult, you’re not alone.
In a recent case series of 100 patients with a median age of 61 years, only 50 patients had an undeniable diagnosis of pityriasis rubra pilaris (PRP). Of those patients, only 26% were diagnosed at initial presentation. The mean delay to diagnosis was 29 months, and 54% required two or more biopsies (JAMA Derm. 2016 Jun 1;152[6]:670-5).
“This is one of those conditions that sometimes you’re going to follow patients and not know what it is right away,” Patricia M. Witman, MD, said at the World Congress of Pediatric Dermatology. Although eczema and contact dermatitis are common diseases where the diagnosis is missed, it’s easy to mistake pityriasis rubra pilaris for psoriasis.
“On the flip side, follicular psoriasis is easy to mistake for PRP,” said Dr. Witman, chief of the division of dermatology at Nationwide Children’s Hospital, Columbus, Ohio. “It’s an uncommon variant that occurs in only about 2.1% of all pediatric psoriasis. These patients can have keratoderma, but they have classic psoriasis on biopsy. Pediatric patients with this subtype do not typically have classic psoriasis plaques.”
PRP is an anti-inflammatory papulosquamous disease with an incidence that ranges between 1:3,500 and 1:400,000. It occurs equally in men and women and has a bimodal onset, with 52%-60% of cases occurring in the 6th or 7th decade of life, and 6%-12% occurring in the 1st or 2nd decade of life, with a mean age of 7 years. Characteristic clinical features include cephalocaudal spread, keratotic follicular papules, well-demarcated orange/red plaques, fine scale, islands of sparing, erythroderma, and palmoplantar keratoderma.
“Even though it’s characteristic, there is a wide spread in the type of disease manifestations,” Dr. Witman said. “There are six different types based on how old you are and on the presentation.”
She limited her presentation to a discussion of three types:
- Classic juvenile type. This type usually presents between ages 5 and 10 and resembles the type I, or classic adult, type, with cephalocaudal spread, follicular keratotic erythematous papules coalescing into plaques, islands of sparing, and typically keratoderma. The scalp dermatitis it causes “often has a little finer scale than the thick micaceous scale we see in psoriasis,” she noted. “Patients can have a photoaggravated presentation with relative sparing of areas protected from the sun.”
- Circumscribed juvenile type. This is the most common pediatric variant. It usually presents between the ages of 3 and 10, with a mean age of 6. It is characterized by sharply demarcated plaques on extensor elbows and knees, as well as follicular hyperkeratosis. About 70% will also have keratoderma. “The Achilles tendon involvement is considered to be fairly pathognomonic for this condition and helps differentiate it from psoriasis, as well as an orange to yellow color of the keratoderma,” Dr. Witman said.
- The atypical juvenile type, or type V. This the familial variant of PRP. It’s also the rarest, occurring in just 6.5% of cases. “It’s autosomal dominant and has incomplete penetrance and variable expression,” she said. “It typically presents in infancy or in the first few years of life. Patients with this form also tend to have a more sclerodermoid palmoplantar keratoderma and ichthyosiform features. It is typically a lifelong condition, but there have been occasional case reports of self-resolution.”
The clinical features of PRP often overlap with psoriasis.
“Although there are some things that are more pathognomonic for PRP, like the Achilles tendon involvement and the keratoderma, for psoriasis we have nail pitting, which we don’t usually see in PRP,” Dr. Witman said. “Sometimes, it’s the skin biopsy that helps us distinguish those defining features, and it may take more than one biopsy to make the diagnosis.”
Dermoscopy can also be helpful. One analysis found that dermoscopy features of PRP include multiple keratotic papules with peripheral rings of erythema that coalesce into a yellow-orange plaque, linear vessels at the periphery of papules, and papules centered on hair (J Am Acad Dermatol. 2015 Jan;72[1]:S58-9).
“Even when you have that definite diagnosis of PRP, you have to remember that PRP can be seen within the context of other disease,” Dr. Witman cautioned. “Malignancy is usually limited to our adult patients with PRP, but infection can certainly trigger PRP in our pediatric patients, most commonly streptococcus. Medication reactions, especially to the biologics, have also been reported to cause PRP-like reactions, as well as autoimmune disease.”
One such entity is referred to as “Wong-like” dermatomyositis, in which patients present with a rash that looks identical to PRP (Ped Dermatol. 2007;24[2]:155-6). “It can occur in both the juvenile and adult populations,” she said. “It has clinical and histopathologic features of PRP, yet it may precede or occur concurrently with a diagnosis of dermatomyositis.”
In 2012, a group of researchers discovered that a gain of function mutation in CARD14 leads to atypical juvenile-type PRP (Am J Hum Genet. 2012 Jul 13;91:163-70). CARD14 is a member of a protein family known as caspase recruitment domain, family member 14, which also is mutated in a variant of familial psoriasis.
“It’s a protein that’s predominantly expressed in the skin, and it’s a known activator of transcription factor nuclear factor kappa light chain enhancer in activated B cells [NFkB], which is responsible for inflammation in the epidermis,” Dr. Witman explained. “What we know is that if you have a gain of function mutation in CARD14, we think that this activates the NFkB pathway and leads to increased inflammation of the skin. The same process would be expected in cases of familial psoriasis.”
Current treatment of PRP is challenging, he said. A recent survey of patients found that 76% found emollients most effective, followed by topical steroids (50%) and salicylic acid (45%) (JAMA Derm. 2016 Jun 1;152[6]:670-5). When it came to systemic therapies, 59% found retinoids most effective, followed by methotrexate (42%) and tumor necrosis factor inhibitors (40%). Only 8% found phototherapy helpful.
Dr. Witman noted that the discovery of the CARD14 mutation as the cause of the familial variant “brings us closer to an understanding of juvenile PRP,” and to the potential for targeted therapy.
“This really raises the question: Do ustekinumab and similar drugs have a future role in the treatment of PRP?” she asked. “We do see anecdotal evidence of clearance in adults using ustekinumab, both those with and without type V PRP and a CARD14 mutation. It has been tried in adult patients, predominantly in those who have failed multiple therapies. But this is anecdotal evidence with isolated case reports. These patients did respond to dosing that is typical for psoriasis.
“At this point, it is not approved for PRP, nor is it approved in children – but it’s something to think about once we have more information,” Dr. Witman noted. “The newer biologics targeting IL[interleukin]-23 and IL-17 may hold promise for PRP, based on what we have learned in psoriasis. But at this point, the safest and most effective therapy for the different variants of PRP in our pediatric patients remains to be seen.”
Dr. Witman reported having no relevant financial disclosures.
AT WCPD 2017
Study findings support uncapping MELD score
Uncapping the current Model for End-Stage Liver Disease score may provide a better path toward making sure that patients most in need of a liver transplant get one, results from a large, long-term analysis showed.
Established in 2002, the Model for End-Stage Liver Disease (MELD) scoring system “was arbitrarily capped at 40 based on the presumption that transplanting patients with MELD greater than 40 would be futile,” researchers led by Mitra K. Nadim, MD, reported in the September 2017 issue of the Journal of Hepatology (67[3]:517-25. doi: 10.1016/j.jhep.2017.04.022). “As a result, patients with MELD greater than 40 receive the same priority as patients with MELD of 40, differentiated only by their time on the wait list.”
The mean age of patients was 53 years, and most were white men. The researchers reported that 3.3% of wait-listed patients had a MELD score of 40 or greater at registration, while 7.3% had MELD scores increase to 40 or greater after wait-list registration. In all, 30,369 patients (40.6%) underwent liver transplantation during the study period. Of these, 2,615 (8.6%) had a MELD score of 40 or greater at the time of their procedure. Compared with patients who had a MELD score of 40, those who had a MELD score of greater than 40 had an increased risk of death within 30 days, and the risk increased with rising scores. Specifically, the hazard ratio was 1.4 for those with a MELD score of 40-44, an HR of 2.6 for those with a MELD score of 45-49, and an HR of 5.0 for those with a MELD score of 50 or greater. There were no survival differences between the two groups at 1 and 3 years, but there was a survival benefit associated with liver transplantation as the MELD score increased above 40, the investigators reported.
“The arbitrary capping of the MELD at 40 has resulted in an unforeseen lack of objectivity for patients with MELD [score of greater than] 40 who are unjustifiably disadvantaged in a system designed to prioritize patients most in need,” they concluded. “Uncapping the MELD score is another necessary step in the evolution of liver allocation and patient prioritization.” They added that a significant number of patients with a MELD score of 40 or greater “likely suffer from acute-on-chronic liver failure (ACLF), a recently recognized syndrome characterized by acute liver decompensation, other organ system failures, and high short-term mortality in patients with end-stage liver disease. A capped MELD score fails to capture acute liver decompensation adequately, and data suggest that a model incorporating sudden increases in MELD predicts wait-list mortality better.”
Dr. Nadim and her associates acknowledged certain limitations of the study, including its retrospective design “and that factors relating to a patient’s suitability for transplantation or to a center’s decision to accept or reject a liver allograft, both of which affect graft and patient survival, were not accounted for in the analysis. Despite these limitations, the study results have important implications for improving the current liver allocation policy.”
The study was supported in part by the Health Resources and Services Administration. The researchers reported having no relevant financial disclosures.
PRIMARY SOURCE: J Hepatol. 2017;67[3]:517-25. doi: 1016/j.jhep.2017.04.022
Uncapping the current Model for End-Stage Liver Disease score may provide a better path toward making sure that patients most in need of a liver transplant get one, results from a large, long-term analysis showed.
Established in 2002, the Model for End-Stage Liver Disease (MELD) scoring system “was arbitrarily capped at 40 based on the presumption that transplanting patients with MELD greater than 40 would be futile,” researchers led by Mitra K. Nadim, MD, reported in the September 2017 issue of the Journal of Hepatology (67[3]:517-25. doi: 10.1016/j.jhep.2017.04.022). “As a result, patients with MELD greater than 40 receive the same priority as patients with MELD of 40, differentiated only by their time on the wait list.”
The mean age of patients was 53 years, and most were white men. The researchers reported that 3.3% of wait-listed patients had a MELD score of 40 or greater at registration, while 7.3% had MELD scores increase to 40 or greater after wait-list registration. In all, 30,369 patients (40.6%) underwent liver transplantation during the study period. Of these, 2,615 (8.6%) had a MELD score of 40 or greater at the time of their procedure. Compared with patients who had a MELD score of 40, those who had a MELD score of greater than 40 had an increased risk of death within 30 days, and the risk increased with rising scores. Specifically, the hazard ratio was 1.4 for those with a MELD score of 40-44, an HR of 2.6 for those with a MELD score of 45-49, and an HR of 5.0 for those with a MELD score of 50 or greater. There were no survival differences between the two groups at 1 and 3 years, but there was a survival benefit associated with liver transplantation as the MELD score increased above 40, the investigators reported.
“The arbitrary capping of the MELD at 40 has resulted in an unforeseen lack of objectivity for patients with MELD [score of greater than] 40 who are unjustifiably disadvantaged in a system designed to prioritize patients most in need,” they concluded. “Uncapping the MELD score is another necessary step in the evolution of liver allocation and patient prioritization.” They added that a significant number of patients with a MELD score of 40 or greater “likely suffer from acute-on-chronic liver failure (ACLF), a recently recognized syndrome characterized by acute liver decompensation, other organ system failures, and high short-term mortality in patients with end-stage liver disease. A capped MELD score fails to capture acute liver decompensation adequately, and data suggest that a model incorporating sudden increases in MELD predicts wait-list mortality better.”
Dr. Nadim and her associates acknowledged certain limitations of the study, including its retrospective design “and that factors relating to a patient’s suitability for transplantation or to a center’s decision to accept or reject a liver allograft, both of which affect graft and patient survival, were not accounted for in the analysis. Despite these limitations, the study results have important implications for improving the current liver allocation policy.”
The study was supported in part by the Health Resources and Services Administration. The researchers reported having no relevant financial disclosures.
PRIMARY SOURCE: J Hepatol. 2017;67[3]:517-25. doi: 1016/j.jhep.2017.04.022
Uncapping the current Model for End-Stage Liver Disease score may provide a better path toward making sure that patients most in need of a liver transplant get one, results from a large, long-term analysis showed.
Established in 2002, the Model for End-Stage Liver Disease (MELD) scoring system “was arbitrarily capped at 40 based on the presumption that transplanting patients with MELD greater than 40 would be futile,” researchers led by Mitra K. Nadim, MD, reported in the September 2017 issue of the Journal of Hepatology (67[3]:517-25. doi: 10.1016/j.jhep.2017.04.022). “As a result, patients with MELD greater than 40 receive the same priority as patients with MELD of 40, differentiated only by their time on the wait list.”
The mean age of patients was 53 years, and most were white men. The researchers reported that 3.3% of wait-listed patients had a MELD score of 40 or greater at registration, while 7.3% had MELD scores increase to 40 or greater after wait-list registration. In all, 30,369 patients (40.6%) underwent liver transplantation during the study period. Of these, 2,615 (8.6%) had a MELD score of 40 or greater at the time of their procedure. Compared with patients who had a MELD score of 40, those who had a MELD score of greater than 40 had an increased risk of death within 30 days, and the risk increased with rising scores. Specifically, the hazard ratio was 1.4 for those with a MELD score of 40-44, an HR of 2.6 for those with a MELD score of 45-49, and an HR of 5.0 for those with a MELD score of 50 or greater. There were no survival differences between the two groups at 1 and 3 years, but there was a survival benefit associated with liver transplantation as the MELD score increased above 40, the investigators reported.
“The arbitrary capping of the MELD at 40 has resulted in an unforeseen lack of objectivity for patients with MELD [score of greater than] 40 who are unjustifiably disadvantaged in a system designed to prioritize patients most in need,” they concluded. “Uncapping the MELD score is another necessary step in the evolution of liver allocation and patient prioritization.” They added that a significant number of patients with a MELD score of 40 or greater “likely suffer from acute-on-chronic liver failure (ACLF), a recently recognized syndrome characterized by acute liver decompensation, other organ system failures, and high short-term mortality in patients with end-stage liver disease. A capped MELD score fails to capture acute liver decompensation adequately, and data suggest that a model incorporating sudden increases in MELD predicts wait-list mortality better.”
Dr. Nadim and her associates acknowledged certain limitations of the study, including its retrospective design “and that factors relating to a patient’s suitability for transplantation or to a center’s decision to accept or reject a liver allograft, both of which affect graft and patient survival, were not accounted for in the analysis. Despite these limitations, the study results have important implications for improving the current liver allocation policy.”
The study was supported in part by the Health Resources and Services Administration. The researchers reported having no relevant financial disclosures.
PRIMARY SOURCE: J Hepatol. 2017;67[3]:517-25. doi: 1016/j.jhep.2017.04.022
FROM THE JOURNAL OF HEPATOLOGY
Key clinical point: .
Major finding: Compared with patients who had a MELD score of 40, the increased risk of death within 30 days was 1.4 for those with a MELD score of 40-44.
Study details: A retrospective analysis of 65,776 patients listed for a liver transplant from February 2002 to December 2012.
Disclosures: The study was supported in part by the Health Resources and Services Administration. The researchers reported having no relevant financial disclosures.
Source: Mitra K. Nadim, MD, et al. Inequity in organ allocation for patients awaiting liver transplantation: Rationale for uncapping the model for end-stage liver disease. J Hepatol. 2017;67(3):517-25. doi: 10.1016/j.jhep.2017.04.022.
Radiofrequency devices appear to reduce vaginal laxity
SAN DIEGO – The first randomized, sham-controlled study of a radiofrequency energy-based device for vaginal laxity showed a significant and sustained effect, and likely raises the bar on vaginal rejuvenation options, Suzanne L. Kilmer, MD, said during a presentation at the annual Masters of Aesthetics Symposium.
“There are a lot of women who have vaginal laxity, vaginal atrophy, and other issues, and this is something that seems to help,” she said. No devices have yet received female rejuvenation/vaginal function indications from the Food and Drug Administration.
Current in-office procedures involve the delivery of radiofrequency (RF) energy, which appears to stimulate collagen production, and the use of fractionated lasers to target the epithelium. “RF devices tend to be easier to use,” said Dr. Kilmer, director of the Laser and Skin Surgery of Northern California, Sacramento. “They’re smaller devices, do not require as much laser training, and they tend to be less expensive. There’s no plume or odor with any of the RF devices.”
She discussed the results of the Viveve Treatment of the Vaginal Introitus to Evaluate Effectiveness (Viveve I) study, conducted at nine sites in four countries, which examined the Viveve monopolar RF device in 155 premenopausal women. The study subjects were randomized to one of two groups: the treatment group received 90 J/cm2 for five passes and the sham group received 1 J/cm2 for five passes (J Sex Med 2017;14[2]:215-25).
The researchers used the Vaginal Laxity Questionnaire (VSQ), which grades vaginal tone on a 7-point scale that ranges from very loose (0) to very tight (7), and the Female Sexual Function Index (FSFI) to collect patient-reported outcomes at one, three, and six months. Subjects had to have a VSQ score of 3 or less to participate in the study.
At 6 months, patients in the treatment group were more than 3 times as likely to have no vaginal laxity, compared with their counterparts in the sham group (P less than or equal to 0.006). In addition, more than half of patients in the treatment group moved at least 2 points on the VSQ scale toward a “tighter” vagina.
“Even a one-point increase in tightness will be significant for women,” said Dr. Kilmer, who has used the Viveve device in her practice but was not part of this study.
Based on responses to the FSFI questionnaire, the researchers observed a significant and sustained improvement in sexual function after a single treatment among patients in the treatment group, compared with those in the sham group. The placebo effect didn’t rise above “dysfunctional” at six months, and rate of treatment emergent adverse events was similar between the treatment and sham groups (11.1% vs. 12.3%, respectively), she said.
The researchers also reported the following patient tolerability variables: warmth during the procedure (96% in the treatment group vs. 19% in the sham group, respectively); cool sensation during the procedure (42% vs. 75%), and stopped procedure due to discomfort (1% in each group).
Dr. Kilmer explained that RF heating of the skin and mucosa provides immediate contraction of collagen, long-term stimulation of new collagen production, as well as increased blood flow and restoration of nerve signaling, which results in normal vaginal lubrication. “The critical RF temperature is in the 35 to 47 degree range,” she said. “Very few people can tolerate above 42 degrees.”
Similarly, good results were noted in a pilot study of the ThermiVa radiofrequency product manufactured by ThermoGen in 23 patients who underwent three treatments one month apart (Int J Laser Aesthet Med. July 2015:16-21). All patients experienced significant change with about a 50% reduction in symptoms.
“Patients are very happy with this treatment,” said Dr. Kilmer, who is also a professor of dermatology at the University of California, Davis Medical Center. “It may not be the absolute home run, but I think it’s very safe ... Most people say it lasts about six months then they’ll start to see some of their symptoms coming back.”
Dr. Kilmer reported that she is a member of the medical advisory board for Allergan, Cytrellis, Lumenis, Merz, Miramar, Sienna Labs, Syneron/Candela, Zarin, Zeltiq, and Zift. She has also received research support from those companies as well as from Cutera, Cynosure, Lutronic, R2 Derm, Solta/Valeant, and Ulthera.
SAN DIEGO – The first randomized, sham-controlled study of a radiofrequency energy-based device for vaginal laxity showed a significant and sustained effect, and likely raises the bar on vaginal rejuvenation options, Suzanne L. Kilmer, MD, said during a presentation at the annual Masters of Aesthetics Symposium.
“There are a lot of women who have vaginal laxity, vaginal atrophy, and other issues, and this is something that seems to help,” she said. No devices have yet received female rejuvenation/vaginal function indications from the Food and Drug Administration.
Current in-office procedures involve the delivery of radiofrequency (RF) energy, which appears to stimulate collagen production, and the use of fractionated lasers to target the epithelium. “RF devices tend to be easier to use,” said Dr. Kilmer, director of the Laser and Skin Surgery of Northern California, Sacramento. “They’re smaller devices, do not require as much laser training, and they tend to be less expensive. There’s no plume or odor with any of the RF devices.”
She discussed the results of the Viveve Treatment of the Vaginal Introitus to Evaluate Effectiveness (Viveve I) study, conducted at nine sites in four countries, which examined the Viveve monopolar RF device in 155 premenopausal women. The study subjects were randomized to one of two groups: the treatment group received 90 J/cm2 for five passes and the sham group received 1 J/cm2 for five passes (J Sex Med 2017;14[2]:215-25).
The researchers used the Vaginal Laxity Questionnaire (VSQ), which grades vaginal tone on a 7-point scale that ranges from very loose (0) to very tight (7), and the Female Sexual Function Index (FSFI) to collect patient-reported outcomes at one, three, and six months. Subjects had to have a VSQ score of 3 or less to participate in the study.
At 6 months, patients in the treatment group were more than 3 times as likely to have no vaginal laxity, compared with their counterparts in the sham group (P less than or equal to 0.006). In addition, more than half of patients in the treatment group moved at least 2 points on the VSQ scale toward a “tighter” vagina.
“Even a one-point increase in tightness will be significant for women,” said Dr. Kilmer, who has used the Viveve device in her practice but was not part of this study.
Based on responses to the FSFI questionnaire, the researchers observed a significant and sustained improvement in sexual function after a single treatment among patients in the treatment group, compared with those in the sham group. The placebo effect didn’t rise above “dysfunctional” at six months, and rate of treatment emergent adverse events was similar between the treatment and sham groups (11.1% vs. 12.3%, respectively), she said.
The researchers also reported the following patient tolerability variables: warmth during the procedure (96% in the treatment group vs. 19% in the sham group, respectively); cool sensation during the procedure (42% vs. 75%), and stopped procedure due to discomfort (1% in each group).
Dr. Kilmer explained that RF heating of the skin and mucosa provides immediate contraction of collagen, long-term stimulation of new collagen production, as well as increased blood flow and restoration of nerve signaling, which results in normal vaginal lubrication. “The critical RF temperature is in the 35 to 47 degree range,” she said. “Very few people can tolerate above 42 degrees.”
Similarly, good results were noted in a pilot study of the ThermiVa radiofrequency product manufactured by ThermoGen in 23 patients who underwent three treatments one month apart (Int J Laser Aesthet Med. July 2015:16-21). All patients experienced significant change with about a 50% reduction in symptoms.
“Patients are very happy with this treatment,” said Dr. Kilmer, who is also a professor of dermatology at the University of California, Davis Medical Center. “It may not be the absolute home run, but I think it’s very safe ... Most people say it lasts about six months then they’ll start to see some of their symptoms coming back.”
Dr. Kilmer reported that she is a member of the medical advisory board for Allergan, Cytrellis, Lumenis, Merz, Miramar, Sienna Labs, Syneron/Candela, Zarin, Zeltiq, and Zift. She has also received research support from those companies as well as from Cutera, Cynosure, Lutronic, R2 Derm, Solta/Valeant, and Ulthera.
SAN DIEGO – The first randomized, sham-controlled study of a radiofrequency energy-based device for vaginal laxity showed a significant and sustained effect, and likely raises the bar on vaginal rejuvenation options, Suzanne L. Kilmer, MD, said during a presentation at the annual Masters of Aesthetics Symposium.
“There are a lot of women who have vaginal laxity, vaginal atrophy, and other issues, and this is something that seems to help,” she said. No devices have yet received female rejuvenation/vaginal function indications from the Food and Drug Administration.
Current in-office procedures involve the delivery of radiofrequency (RF) energy, which appears to stimulate collagen production, and the use of fractionated lasers to target the epithelium. “RF devices tend to be easier to use,” said Dr. Kilmer, director of the Laser and Skin Surgery of Northern California, Sacramento. “They’re smaller devices, do not require as much laser training, and they tend to be less expensive. There’s no plume or odor with any of the RF devices.”
She discussed the results of the Viveve Treatment of the Vaginal Introitus to Evaluate Effectiveness (Viveve I) study, conducted at nine sites in four countries, which examined the Viveve monopolar RF device in 155 premenopausal women. The study subjects were randomized to one of two groups: the treatment group received 90 J/cm2 for five passes and the sham group received 1 J/cm2 for five passes (J Sex Med 2017;14[2]:215-25).
The researchers used the Vaginal Laxity Questionnaire (VSQ), which grades vaginal tone on a 7-point scale that ranges from very loose (0) to very tight (7), and the Female Sexual Function Index (FSFI) to collect patient-reported outcomes at one, three, and six months. Subjects had to have a VSQ score of 3 or less to participate in the study.
At 6 months, patients in the treatment group were more than 3 times as likely to have no vaginal laxity, compared with their counterparts in the sham group (P less than or equal to 0.006). In addition, more than half of patients in the treatment group moved at least 2 points on the VSQ scale toward a “tighter” vagina.
“Even a one-point increase in tightness will be significant for women,” said Dr. Kilmer, who has used the Viveve device in her practice but was not part of this study.
Based on responses to the FSFI questionnaire, the researchers observed a significant and sustained improvement in sexual function after a single treatment among patients in the treatment group, compared with those in the sham group. The placebo effect didn’t rise above “dysfunctional” at six months, and rate of treatment emergent adverse events was similar between the treatment and sham groups (11.1% vs. 12.3%, respectively), she said.
The researchers also reported the following patient tolerability variables: warmth during the procedure (96% in the treatment group vs. 19% in the sham group, respectively); cool sensation during the procedure (42% vs. 75%), and stopped procedure due to discomfort (1% in each group).
Dr. Kilmer explained that RF heating of the skin and mucosa provides immediate contraction of collagen, long-term stimulation of new collagen production, as well as increased blood flow and restoration of nerve signaling, which results in normal vaginal lubrication. “The critical RF temperature is in the 35 to 47 degree range,” she said. “Very few people can tolerate above 42 degrees.”
Similarly, good results were noted in a pilot study of the ThermiVa radiofrequency product manufactured by ThermoGen in 23 patients who underwent three treatments one month apart (Int J Laser Aesthet Med. July 2015:16-21). All patients experienced significant change with about a 50% reduction in symptoms.
“Patients are very happy with this treatment,” said Dr. Kilmer, who is also a professor of dermatology at the University of California, Davis Medical Center. “It may not be the absolute home run, but I think it’s very safe ... Most people say it lasts about six months then they’ll start to see some of their symptoms coming back.”
Dr. Kilmer reported that she is a member of the medical advisory board for Allergan, Cytrellis, Lumenis, Merz, Miramar, Sienna Labs, Syneron/Candela, Zarin, Zeltiq, and Zift. She has also received research support from those companies as well as from Cutera, Cynosure, Lutronic, R2 Derm, Solta/Valeant, and Ulthera.
REPORTING FROM MOAS 2017
Maintenance therapy typically required after laser hair removal
REPORTING FROM MOAS 2017
SAN DIEGO – Hair removal ranks as the most popular laser procedure performed in the United States, but patients with blond, red, or gray hairs are out of luck, since those threadlike strands lack a chromophore for the laser to respond to.
“For now, I recommend that these patients get electrolysis or use eflornithine cream,” Arisa Ortiz, MD, said at the annual Masters of Aesthetics Symposium.
Future treatment options for patients with light-colored hair look promising, however. One emerging technology combines laser hair removal with the insertion of a silver nanoparticle into the unpigmented hair follicle. “These are currently in pivotal trials, so we should be seeing them on the market very soon,” she said.
According to Dr. Ortiz, director of laser and cosmetic dermatology in the department of dermatology at the University of California, San Diego, there is still a place for nonlaser hair removal, including shaving, waxing, threading, and electrolysis, but laser hair removal is safe, effective in skilled hands, and permanent. Key factors in optimizing treatment include understanding laser safety and laser-tissue interaction, proper patient selection, preoperative preparation, parameter selection, and recognizing complications.
The first-degree target in laser hair removal is eumelanin contained in the bulb of hair follicles, she said, but the heat must diffuse to a secondary target – follicular stem cells in the bulge of the outer root sheath. “Pulse duration is important,” she said. “The thermal relaxation time of a terminal hair follicle is roughly 100 milliseconds. Longer pulse widths are going to be safer for darker skin types, and you want shorter pulse durations for fine hair, and longer pulse durations for thicker hair. Spot size is also important. Larger spot sizes are faster and create less pain and less epidermal damage.”
Indications include unwanted hair, hypertrichosis, and hirsutism/polycystic ovary syndrome (PCOS). “You want to counsel patients with PCOS properly, because they will require multiple treatments as they tend to make new hair follicles,” she said. Other indications include ingrown hairs, pseudofolliculitis barbae, and pilonidal cysts.
The best candidates for laser hair removal are patients who have a light skin color and dark hair, and those who have thick, coarse hair. “Be cautious when treating tanned patients, and adjust your setting to a longer pulse duration and a lower fluence,” she continued. “I tell (patients) they’ll likely need at least six treatments. You want to treat them every 6 to 8 weeks. If you do treatments sooner than that, it’s probably not cost effective for the patient, because of the way hair follicles cycle. It’s also important that they avoid the sun.”
Clinicians can achieve temporary hair removal with Q-switched lasers, which may be suitable for patients with pseudofolliculitis barbae but who may not want permanent hair removal. “This will just vaporize the actual hair follicle, but that heat is not extending to the stem cells, so it’s temporary hair removal, because the hair follicle transitions into the telogen phase,” Dr. Ortiz explained. “The hair will then grow back after a few months.”
Endpoints are the most important factor for laser hair removal. You want to see perifollicular erythema, perifollicular edema, or hair singeing. “Then you know you have an effective treatment setting,” she said. “Sometimes, however, it takes time for this erythema or edema to develop, so you don’t want to keep increasing your fluences to see this end point. If you’re not comfortable with the laser you’re using, I recommend waiting a few minutes after treatment, and looking for the end point. You could always go higher during the next treatment, if you need to.”
Higher fluences have been correlated with greater permanent hair removal, but also with more side effects. “The recommended treatment settings are going to be the highest possible tolerated fluence that yields the desired endpoint without any adverse effects,” Dr. Ortiz said.
The first hair removal laser to hit the market was the Ruby 694-nm laser, which is safe for Fitzpatrick skin types I-III. A long-term follow-up of the seminal study showed permanent posttreatment efficacy of up to 2 years (Arch Dermatol. 1998;134[7]:837-42). The Alexandrite 755-nm laser, meanwhile, penetrates deeper because it’s a longer wavelength, so there’s less melanin absorption, and it’s safer for darker skin types. “With a device like this, you want to make sure that you’re always holding the laser perpendicular to the skin surface so that your cryogen spray is firing at the same area as the laser. [That way] you don’t get a burn injury,” she said.
The diode at 800 nm and 810 nm penetrates even deeper, which results in less melanin absorption. “Originally these devices had smaller spot sizes, but now some of the newer devices have larger hand pieces and use contact cooling,” she said. “Some of the diode lasers cause singeing and char. The carbon actually sticks onto the sapphire window of the device, so you want to make sure you swipe the window after every few pulses so that you’re not putting the char onto the epidermis and causing an epidermal burn,” Dr. Ortiz advised.
She described the Nd:YAG 1,064-nm laser as the safest for skin types V and VI. It has the deepest penetration but the least melanin absorption. Intense pulsed light (IPL) can also be used for hair removal. IPLs “have a larger spot size, and you can use various cutoff filters to make them safer for darker skin types,” she said. “However, in head-to-head studies, usually laser hair removal does better than IPL.”
Potential complications from laser hair removal include paradoxical hypertrichosis; pigmentary alterations such as hyperpigmentation or hypopigmentation; infections/folliculitis, scarring, and eye injury. Dr. Ortiz underscored the importance of counseling patients about the need for maintenance treatments prior to initiating their first hair removal session. Laser hair removal removes about 85-90% of hairs permanently “so that leaves a significant number that remain, and new hairs may grow over time,” she said.
Authors of a recent study found that the plume release during laser hair removal should be considered a potential biohazard that warrants the use of smoke evacuators and good room ventilation (JAMA Dermatol. 2016;152[12]:1320-26). “We are learning that we should be more careful to evacuate the plume from laser hair removal or wear laser protective masks as the plume may contain harmful chemicals that we breathe in on a daily basis,” said Dr. Ortiz, who was not affiliated with the analysis.
She disclosed serving as a consultant to, receiving equipment from, and/or being a member of the scientific board of several device companies, including Alastin, Allergan, BTL, Cutera, InMode, Merz, Revance, Rodan and Fields, Sciton, and Sienna Biopharmaceuticals.
-[email protected]
REPORTING FROM MOAS 2017
SAN DIEGO – Hair removal ranks as the most popular laser procedure performed in the United States, but patients with blond, red, or gray hairs are out of luck, since those threadlike strands lack a chromophore for the laser to respond to.
“For now, I recommend that these patients get electrolysis or use eflornithine cream,” Arisa Ortiz, MD, said at the annual Masters of Aesthetics Symposium.
Future treatment options for patients with light-colored hair look promising, however. One emerging technology combines laser hair removal with the insertion of a silver nanoparticle into the unpigmented hair follicle. “These are currently in pivotal trials, so we should be seeing them on the market very soon,” she said.
According to Dr. Ortiz, director of laser and cosmetic dermatology in the department of dermatology at the University of California, San Diego, there is still a place for nonlaser hair removal, including shaving, waxing, threading, and electrolysis, but laser hair removal is safe, effective in skilled hands, and permanent. Key factors in optimizing treatment include understanding laser safety and laser-tissue interaction, proper patient selection, preoperative preparation, parameter selection, and recognizing complications.
The first-degree target in laser hair removal is eumelanin contained in the bulb of hair follicles, she said, but the heat must diffuse to a secondary target – follicular stem cells in the bulge of the outer root sheath. “Pulse duration is important,” she said. “The thermal relaxation time of a terminal hair follicle is roughly 100 milliseconds. Longer pulse widths are going to be safer for darker skin types, and you want shorter pulse durations for fine hair, and longer pulse durations for thicker hair. Spot size is also important. Larger spot sizes are faster and create less pain and less epidermal damage.”
Indications include unwanted hair, hypertrichosis, and hirsutism/polycystic ovary syndrome (PCOS). “You want to counsel patients with PCOS properly, because they will require multiple treatments as they tend to make new hair follicles,” she said. Other indications include ingrown hairs, pseudofolliculitis barbae, and pilonidal cysts.
The best candidates for laser hair removal are patients who have a light skin color and dark hair, and those who have thick, coarse hair. “Be cautious when treating tanned patients, and adjust your setting to a longer pulse duration and a lower fluence,” she continued. “I tell (patients) they’ll likely need at least six treatments. You want to treat them every 6 to 8 weeks. If you do treatments sooner than that, it’s probably not cost effective for the patient, because of the way hair follicles cycle. It’s also important that they avoid the sun.”
Clinicians can achieve temporary hair removal with Q-switched lasers, which may be suitable for patients with pseudofolliculitis barbae but who may not want permanent hair removal. “This will just vaporize the actual hair follicle, but that heat is not extending to the stem cells, so it’s temporary hair removal, because the hair follicle transitions into the telogen phase,” Dr. Ortiz explained. “The hair will then grow back after a few months.”
Endpoints are the most important factor for laser hair removal. You want to see perifollicular erythema, perifollicular edema, or hair singeing. “Then you know you have an effective treatment setting,” she said. “Sometimes, however, it takes time for this erythema or edema to develop, so you don’t want to keep increasing your fluences to see this end point. If you’re not comfortable with the laser you’re using, I recommend waiting a few minutes after treatment, and looking for the end point. You could always go higher during the next treatment, if you need to.”
Higher fluences have been correlated with greater permanent hair removal, but also with more side effects. “The recommended treatment settings are going to be the highest possible tolerated fluence that yields the desired endpoint without any adverse effects,” Dr. Ortiz said.
The first hair removal laser to hit the market was the Ruby 694-nm laser, which is safe for Fitzpatrick skin types I-III. A long-term follow-up of the seminal study showed permanent posttreatment efficacy of up to 2 years (Arch Dermatol. 1998;134[7]:837-42). The Alexandrite 755-nm laser, meanwhile, penetrates deeper because it’s a longer wavelength, so there’s less melanin absorption, and it’s safer for darker skin types. “With a device like this, you want to make sure that you’re always holding the laser perpendicular to the skin surface so that your cryogen spray is firing at the same area as the laser. [That way] you don’t get a burn injury,” she said.
The diode at 800 nm and 810 nm penetrates even deeper, which results in less melanin absorption. “Originally these devices had smaller spot sizes, but now some of the newer devices have larger hand pieces and use contact cooling,” she said. “Some of the diode lasers cause singeing and char. The carbon actually sticks onto the sapphire window of the device, so you want to make sure you swipe the window after every few pulses so that you’re not putting the char onto the epidermis and causing an epidermal burn,” Dr. Ortiz advised.
She described the Nd:YAG 1,064-nm laser as the safest for skin types V and VI. It has the deepest penetration but the least melanin absorption. Intense pulsed light (IPL) can also be used for hair removal. IPLs “have a larger spot size, and you can use various cutoff filters to make them safer for darker skin types,” she said. “However, in head-to-head studies, usually laser hair removal does better than IPL.”
Potential complications from laser hair removal include paradoxical hypertrichosis; pigmentary alterations such as hyperpigmentation or hypopigmentation; infections/folliculitis, scarring, and eye injury. Dr. Ortiz underscored the importance of counseling patients about the need for maintenance treatments prior to initiating their first hair removal session. Laser hair removal removes about 85-90% of hairs permanently “so that leaves a significant number that remain, and new hairs may grow over time,” she said.
Authors of a recent study found that the plume release during laser hair removal should be considered a potential biohazard that warrants the use of smoke evacuators and good room ventilation (JAMA Dermatol. 2016;152[12]:1320-26). “We are learning that we should be more careful to evacuate the plume from laser hair removal or wear laser protective masks as the plume may contain harmful chemicals that we breathe in on a daily basis,” said Dr. Ortiz, who was not affiliated with the analysis.
She disclosed serving as a consultant to, receiving equipment from, and/or being a member of the scientific board of several device companies, including Alastin, Allergan, BTL, Cutera, InMode, Merz, Revance, Rodan and Fields, Sciton, and Sienna Biopharmaceuticals.
-[email protected]
REPORTING FROM MOAS 2017
SAN DIEGO – Hair removal ranks as the most popular laser procedure performed in the United States, but patients with blond, red, or gray hairs are out of luck, since those threadlike strands lack a chromophore for the laser to respond to.
“For now, I recommend that these patients get electrolysis or use eflornithine cream,” Arisa Ortiz, MD, said at the annual Masters of Aesthetics Symposium.
Future treatment options for patients with light-colored hair look promising, however. One emerging technology combines laser hair removal with the insertion of a silver nanoparticle into the unpigmented hair follicle. “These are currently in pivotal trials, so we should be seeing them on the market very soon,” she said.
According to Dr. Ortiz, director of laser and cosmetic dermatology in the department of dermatology at the University of California, San Diego, there is still a place for nonlaser hair removal, including shaving, waxing, threading, and electrolysis, but laser hair removal is safe, effective in skilled hands, and permanent. Key factors in optimizing treatment include understanding laser safety and laser-tissue interaction, proper patient selection, preoperative preparation, parameter selection, and recognizing complications.
The first-degree target in laser hair removal is eumelanin contained in the bulb of hair follicles, she said, but the heat must diffuse to a secondary target – follicular stem cells in the bulge of the outer root sheath. “Pulse duration is important,” she said. “The thermal relaxation time of a terminal hair follicle is roughly 100 milliseconds. Longer pulse widths are going to be safer for darker skin types, and you want shorter pulse durations for fine hair, and longer pulse durations for thicker hair. Spot size is also important. Larger spot sizes are faster and create less pain and less epidermal damage.”
Indications include unwanted hair, hypertrichosis, and hirsutism/polycystic ovary syndrome (PCOS). “You want to counsel patients with PCOS properly, because they will require multiple treatments as they tend to make new hair follicles,” she said. Other indications include ingrown hairs, pseudofolliculitis barbae, and pilonidal cysts.
The best candidates for laser hair removal are patients who have a light skin color and dark hair, and those who have thick, coarse hair. “Be cautious when treating tanned patients, and adjust your setting to a longer pulse duration and a lower fluence,” she continued. “I tell (patients) they’ll likely need at least six treatments. You want to treat them every 6 to 8 weeks. If you do treatments sooner than that, it’s probably not cost effective for the patient, because of the way hair follicles cycle. It’s also important that they avoid the sun.”
Clinicians can achieve temporary hair removal with Q-switched lasers, which may be suitable for patients with pseudofolliculitis barbae but who may not want permanent hair removal. “This will just vaporize the actual hair follicle, but that heat is not extending to the stem cells, so it’s temporary hair removal, because the hair follicle transitions into the telogen phase,” Dr. Ortiz explained. “The hair will then grow back after a few months.”
Endpoints are the most important factor for laser hair removal. You want to see perifollicular erythema, perifollicular edema, or hair singeing. “Then you know you have an effective treatment setting,” she said. “Sometimes, however, it takes time for this erythema or edema to develop, so you don’t want to keep increasing your fluences to see this end point. If you’re not comfortable with the laser you’re using, I recommend waiting a few minutes after treatment, and looking for the end point. You could always go higher during the next treatment, if you need to.”
Higher fluences have been correlated with greater permanent hair removal, but also with more side effects. “The recommended treatment settings are going to be the highest possible tolerated fluence that yields the desired endpoint without any adverse effects,” Dr. Ortiz said.
The first hair removal laser to hit the market was the Ruby 694-nm laser, which is safe for Fitzpatrick skin types I-III. A long-term follow-up of the seminal study showed permanent posttreatment efficacy of up to 2 years (Arch Dermatol. 1998;134[7]:837-42). The Alexandrite 755-nm laser, meanwhile, penetrates deeper because it’s a longer wavelength, so there’s less melanin absorption, and it’s safer for darker skin types. “With a device like this, you want to make sure that you’re always holding the laser perpendicular to the skin surface so that your cryogen spray is firing at the same area as the laser. [That way] you don’t get a burn injury,” she said.
The diode at 800 nm and 810 nm penetrates even deeper, which results in less melanin absorption. “Originally these devices had smaller spot sizes, but now some of the newer devices have larger hand pieces and use contact cooling,” she said. “Some of the diode lasers cause singeing and char. The carbon actually sticks onto the sapphire window of the device, so you want to make sure you swipe the window after every few pulses so that you’re not putting the char onto the epidermis and causing an epidermal burn,” Dr. Ortiz advised.
She described the Nd:YAG 1,064-nm laser as the safest for skin types V and VI. It has the deepest penetration but the least melanin absorption. Intense pulsed light (IPL) can also be used for hair removal. IPLs “have a larger spot size, and you can use various cutoff filters to make them safer for darker skin types,” she said. “However, in head-to-head studies, usually laser hair removal does better than IPL.”
Potential complications from laser hair removal include paradoxical hypertrichosis; pigmentary alterations such as hyperpigmentation or hypopigmentation; infections/folliculitis, scarring, and eye injury. Dr. Ortiz underscored the importance of counseling patients about the need for maintenance treatments prior to initiating their first hair removal session. Laser hair removal removes about 85-90% of hairs permanently “so that leaves a significant number that remain, and new hairs may grow over time,” she said.
Authors of a recent study found that the plume release during laser hair removal should be considered a potential biohazard that warrants the use of smoke evacuators and good room ventilation (JAMA Dermatol. 2016;152[12]:1320-26). “We are learning that we should be more careful to evacuate the plume from laser hair removal or wear laser protective masks as the plume may contain harmful chemicals that we breathe in on a daily basis,” said Dr. Ortiz, who was not affiliated with the analysis.
She disclosed serving as a consultant to, receiving equipment from, and/or being a member of the scientific board of several device companies, including Alastin, Allergan, BTL, Cutera, InMode, Merz, Revance, Rodan and Fields, Sciton, and Sienna Biopharmaceuticals.
-[email protected]
How to tackle telangiectasias with light
AT MOAS 2017
SAN DIEGO – Multiple light-based devices can be used to treat telangiectasias, often with little or no down time.
During a presentation at the annual Masters of Aesthetics Symposium, Kristen M. Kelly, MD, listed her preferred light-based treatment options for telangiectasias as the pulsed dye laser (PDL), the 532 nm Nd:YAG laser, and the diode laser. The PDL has been around the longest and “is one of the greatest devices for treating vasculature, because it’s very specific,” she said. Purpura can result, but for cosmetic indications, pulse durations of 6 milliseconds or more work well. “Keep in mind, though, that when you’re using longer pulse durations, patients will often require more than one treatment,” she said. “Most people are okay with that, knowing that they’re going to have minimal to no down time with these procedures.”
Dr. Kelly, professor of dermatology and surgery at the University of California, Irvine, noted that erythematotelangiectatic rosacea generally responds well to light-based devices, while papulopustular/inflammatory forms of the condition are best treated with anti-inflammatory agents or antibiotics. Multiple passes or judicious pulse stacking can be used with PDL for treating telangiectases, “but always know what your endpoint is,” Dr. Kelly advised. “You generally don’t want to pulse over purpura when treating telangiectasias; that just increases the risk of adverse effects.”
Settings to consider vary, depending on the patient and the area to be treated. The desired endpoints for telangiectasia are vessel blanching or diminution, or a darker red/purple change to the vessel. “You should not see graying or whitening of the skin; that’s when you’re getting epidermal damage, so you want to watch for that,” she said. For a first pass, Dr. Kelly will often treat with a spot size of 10 mm or 12 mm with a 6-millisecond pulse duration with cryogen spray cooling set at 30 milliseconds with a 30-millisecond delay. If a second pass is required, she will often treat with a spot size of 7 mm and a 6-millisecond pulse duration and slightly higher fluence, again using cryogen spray cooling. “It is important to know your specific device to determine settings,” she said.
The frequency-doubled Nd:YAG laser features a wavelength of 532 nm but requires cautious use in patients with darker skin types or photodamaged skin. The desired endpoint is a darkening of the vessel or vessel disappearance. “Many of these devices have contact cooling, which is an excellent method of cooling, but you have to make sure you keep the contact,” she said. Other cooling options include cryogen spray and the application of cold air. “When you’re doing cold-air cooling, you want to be careful not to point it toward someone’s nose,” she said. “It sounds funny, but this is uncomfortable for the patient.”
Diode lasers with wavelengths of 800-980 nm allow the user to treat larger blood vessels, such as nasal telangiectasias. “Some devices with small spot sizes allow you to trace along the vessel, and you can see it disappear before your eyes, and when the patient leaves, they’re generally very happy,” she said.
Intense pulsed light works well in patients with both pigmentary and vascular changes, especially for poikiloderma with brown and red pigment. “Multiple treatments are required, and there is significant melanin absorption, so you don’t want to treat people with tanned skin,” she said.
Dr. Kelly emphasized the importance of being familiar with the device you use and knowing the desired tissue endpoint. Decisions depend on the patient’s skin type, their tolerance for down time and multiple treatments, and the devices at your disposal. “Patients should be aware of all options, even if you may not have a certain device in your office,” she said. “You can refer them.”
She disclosed having drugs or devices donated by Light Sciences Oncology, Solta Medical, Syneron Candela, ThermiRF, and Novartis. She is also a consultant for MundiPharma, Allergan, and Syneron Candela.
[email protected]
AT MOAS 2017
SAN DIEGO – Multiple light-based devices can be used to treat telangiectasias, often with little or no down time.
During a presentation at the annual Masters of Aesthetics Symposium, Kristen M. Kelly, MD, listed her preferred light-based treatment options for telangiectasias as the pulsed dye laser (PDL), the 532 nm Nd:YAG laser, and the diode laser. The PDL has been around the longest and “is one of the greatest devices for treating vasculature, because it’s very specific,” she said. Purpura can result, but for cosmetic indications, pulse durations of 6 milliseconds or more work well. “Keep in mind, though, that when you’re using longer pulse durations, patients will often require more than one treatment,” she said. “Most people are okay with that, knowing that they’re going to have minimal to no down time with these procedures.”
Dr. Kelly, professor of dermatology and surgery at the University of California, Irvine, noted that erythematotelangiectatic rosacea generally responds well to light-based devices, while papulopustular/inflammatory forms of the condition are best treated with anti-inflammatory agents or antibiotics. Multiple passes or judicious pulse stacking can be used with PDL for treating telangiectases, “but always know what your endpoint is,” Dr. Kelly advised. “You generally don’t want to pulse over purpura when treating telangiectasias; that just increases the risk of adverse effects.”
Settings to consider vary, depending on the patient and the area to be treated. The desired endpoints for telangiectasia are vessel blanching or diminution, or a darker red/purple change to the vessel. “You should not see graying or whitening of the skin; that’s when you’re getting epidermal damage, so you want to watch for that,” she said. For a first pass, Dr. Kelly will often treat with a spot size of 10 mm or 12 mm with a 6-millisecond pulse duration with cryogen spray cooling set at 30 milliseconds with a 30-millisecond delay. If a second pass is required, she will often treat with a spot size of 7 mm and a 6-millisecond pulse duration and slightly higher fluence, again using cryogen spray cooling. “It is important to know your specific device to determine settings,” she said.
The frequency-doubled Nd:YAG laser features a wavelength of 532 nm but requires cautious use in patients with darker skin types or photodamaged skin. The desired endpoint is a darkening of the vessel or vessel disappearance. “Many of these devices have contact cooling, which is an excellent method of cooling, but you have to make sure you keep the contact,” she said. Other cooling options include cryogen spray and the application of cold air. “When you’re doing cold-air cooling, you want to be careful not to point it toward someone’s nose,” she said. “It sounds funny, but this is uncomfortable for the patient.”
Diode lasers with wavelengths of 800-980 nm allow the user to treat larger blood vessels, such as nasal telangiectasias. “Some devices with small spot sizes allow you to trace along the vessel, and you can see it disappear before your eyes, and when the patient leaves, they’re generally very happy,” she said.
Intense pulsed light works well in patients with both pigmentary and vascular changes, especially for poikiloderma with brown and red pigment. “Multiple treatments are required, and there is significant melanin absorption, so you don’t want to treat people with tanned skin,” she said.
Dr. Kelly emphasized the importance of being familiar with the device you use and knowing the desired tissue endpoint. Decisions depend on the patient’s skin type, their tolerance for down time and multiple treatments, and the devices at your disposal. “Patients should be aware of all options, even if you may not have a certain device in your office,” she said. “You can refer them.”
She disclosed having drugs or devices donated by Light Sciences Oncology, Solta Medical, Syneron Candela, ThermiRF, and Novartis. She is also a consultant for MundiPharma, Allergan, and Syneron Candela.
[email protected]
AT MOAS 2017
SAN DIEGO – Multiple light-based devices can be used to treat telangiectasias, often with little or no down time.
During a presentation at the annual Masters of Aesthetics Symposium, Kristen M. Kelly, MD, listed her preferred light-based treatment options for telangiectasias as the pulsed dye laser (PDL), the 532 nm Nd:YAG laser, and the diode laser. The PDL has been around the longest and “is one of the greatest devices for treating vasculature, because it’s very specific,” she said. Purpura can result, but for cosmetic indications, pulse durations of 6 milliseconds or more work well. “Keep in mind, though, that when you’re using longer pulse durations, patients will often require more than one treatment,” she said. “Most people are okay with that, knowing that they’re going to have minimal to no down time with these procedures.”
Dr. Kelly, professor of dermatology and surgery at the University of California, Irvine, noted that erythematotelangiectatic rosacea generally responds well to light-based devices, while papulopustular/inflammatory forms of the condition are best treated with anti-inflammatory agents or antibiotics. Multiple passes or judicious pulse stacking can be used with PDL for treating telangiectases, “but always know what your endpoint is,” Dr. Kelly advised. “You generally don’t want to pulse over purpura when treating telangiectasias; that just increases the risk of adverse effects.”
Settings to consider vary, depending on the patient and the area to be treated. The desired endpoints for telangiectasia are vessel blanching or diminution, or a darker red/purple change to the vessel. “You should not see graying or whitening of the skin; that’s when you’re getting epidermal damage, so you want to watch for that,” she said. For a first pass, Dr. Kelly will often treat with a spot size of 10 mm or 12 mm with a 6-millisecond pulse duration with cryogen spray cooling set at 30 milliseconds with a 30-millisecond delay. If a second pass is required, she will often treat with a spot size of 7 mm and a 6-millisecond pulse duration and slightly higher fluence, again using cryogen spray cooling. “It is important to know your specific device to determine settings,” she said.
The frequency-doubled Nd:YAG laser features a wavelength of 532 nm but requires cautious use in patients with darker skin types or photodamaged skin. The desired endpoint is a darkening of the vessel or vessel disappearance. “Many of these devices have contact cooling, which is an excellent method of cooling, but you have to make sure you keep the contact,” she said. Other cooling options include cryogen spray and the application of cold air. “When you’re doing cold-air cooling, you want to be careful not to point it toward someone’s nose,” she said. “It sounds funny, but this is uncomfortable for the patient.”
Diode lasers with wavelengths of 800-980 nm allow the user to treat larger blood vessels, such as nasal telangiectasias. “Some devices with small spot sizes allow you to trace along the vessel, and you can see it disappear before your eyes, and when the patient leaves, they’re generally very happy,” she said.
Intense pulsed light works well in patients with both pigmentary and vascular changes, especially for poikiloderma with brown and red pigment. “Multiple treatments are required, and there is significant melanin absorption, so you don’t want to treat people with tanned skin,” she said.
Dr. Kelly emphasized the importance of being familiar with the device you use and knowing the desired tissue endpoint. Decisions depend on the patient’s skin type, their tolerance for down time and multiple treatments, and the devices at your disposal. “Patients should be aware of all options, even if you may not have a certain device in your office,” she said. “You can refer them.”
She disclosed having drugs or devices donated by Light Sciences Oncology, Solta Medical, Syneron Candela, ThermiRF, and Novartis. She is also a consultant for MundiPharma, Allergan, and Syneron Candela.
[email protected]
Tips for avoiding laser treatment complications
SAN DIEGO – The way Mathew M. Avram, MD, JD, sees it, the best way to avoid complications from using lasers for aesthetic procedures is to trust your own eyes, not the laser device itself.
“Lasers are never perfect,” he said at the annual Masters of Aesthetics Symposium. “The same device made by the same manufacturer may produce highly different outputs at the same setting. Moreover, lasers produce much different energies after they’ve been serviced. So, if you have two devices sitting right next to each other, don’t assume that the energy output on one device is exactly the same as the other device.”
He also warned clinicians against taking a “cookbook approach” to using lasers, such as memorizing settings or using ones recommended by a colleague or a device manufacturer. “Some lasers are not externally calibrated,” said Dr. Avram, who is codirector of the Massachusetts General Hospital/Wellman Laser and Cosmetic Fellowship. “Safe and unsafe laser endpoints and close clinical observation are the best means to avoiding complications. Learn your endpoints. This is true with the selective photothermolysis lasers: the pigment lasers, vascular lasers, and laser hair removal. Unfortunately, when you use nonablative fractional lasers, there really isn’t an endpoint, so it’s going to be more difficult to discern in that case. The key clinical finding is the endpoint, not the energy setting.”
When treating pigmented lesions and tattoos, for example, immediate whitening is the desired endpoint, not tissue splatter. “So, if you see the epidermis fly off with your first pulse, dial it down,” Dr. Avram said. “It sounds obvious, but sometimes, if you’re working quickly, you figure it will be all right. Just stop and make sure you’re seeing what you’re supposed to be seeing.”
The desired endpoints for vascular lasers, meanwhile, include purpura, transient purpura, or vessel clearance. “What you don’t want to see is gray,” he said. Desired endpoints for hair removal include perifollicular edema and erythema. “What you don’t want to see is epidermal change or dermal tightening,” he added. “Observe the skin and the patient. If the skin is reacting strangely, stop and check all of your settings. If the patient is having an inordinate amount of pain, stop and check all of your settings. These are often the clues that can help you avoid harming a patient.”
Dr. Avram disclosed that he has received consulting fees from Allergan, Merz, Sciton, Soliton, and Zalea. He also reported having ownership and/or shareholder interest in Cytrellis, Invasix, and Zalea.
SAN DIEGO – The way Mathew M. Avram, MD, JD, sees it, the best way to avoid complications from using lasers for aesthetic procedures is to trust your own eyes, not the laser device itself.
“Lasers are never perfect,” he said at the annual Masters of Aesthetics Symposium. “The same device made by the same manufacturer may produce highly different outputs at the same setting. Moreover, lasers produce much different energies after they’ve been serviced. So, if you have two devices sitting right next to each other, don’t assume that the energy output on one device is exactly the same as the other device.”
He also warned clinicians against taking a “cookbook approach” to using lasers, such as memorizing settings or using ones recommended by a colleague or a device manufacturer. “Some lasers are not externally calibrated,” said Dr. Avram, who is codirector of the Massachusetts General Hospital/Wellman Laser and Cosmetic Fellowship. “Safe and unsafe laser endpoints and close clinical observation are the best means to avoiding complications. Learn your endpoints. This is true with the selective photothermolysis lasers: the pigment lasers, vascular lasers, and laser hair removal. Unfortunately, when you use nonablative fractional lasers, there really isn’t an endpoint, so it’s going to be more difficult to discern in that case. The key clinical finding is the endpoint, not the energy setting.”
When treating pigmented lesions and tattoos, for example, immediate whitening is the desired endpoint, not tissue splatter. “So, if you see the epidermis fly off with your first pulse, dial it down,” Dr. Avram said. “It sounds obvious, but sometimes, if you’re working quickly, you figure it will be all right. Just stop and make sure you’re seeing what you’re supposed to be seeing.”
The desired endpoints for vascular lasers, meanwhile, include purpura, transient purpura, or vessel clearance. “What you don’t want to see is gray,” he said. Desired endpoints for hair removal include perifollicular edema and erythema. “What you don’t want to see is epidermal change or dermal tightening,” he added. “Observe the skin and the patient. If the skin is reacting strangely, stop and check all of your settings. If the patient is having an inordinate amount of pain, stop and check all of your settings. These are often the clues that can help you avoid harming a patient.”
Dr. Avram disclosed that he has received consulting fees from Allergan, Merz, Sciton, Soliton, and Zalea. He also reported having ownership and/or shareholder interest in Cytrellis, Invasix, and Zalea.
SAN DIEGO – The way Mathew M. Avram, MD, JD, sees it, the best way to avoid complications from using lasers for aesthetic procedures is to trust your own eyes, not the laser device itself.
“Lasers are never perfect,” he said at the annual Masters of Aesthetics Symposium. “The same device made by the same manufacturer may produce highly different outputs at the same setting. Moreover, lasers produce much different energies after they’ve been serviced. So, if you have two devices sitting right next to each other, don’t assume that the energy output on one device is exactly the same as the other device.”
He also warned clinicians against taking a “cookbook approach” to using lasers, such as memorizing settings or using ones recommended by a colleague or a device manufacturer. “Some lasers are not externally calibrated,” said Dr. Avram, who is codirector of the Massachusetts General Hospital/Wellman Laser and Cosmetic Fellowship. “Safe and unsafe laser endpoints and close clinical observation are the best means to avoiding complications. Learn your endpoints. This is true with the selective photothermolysis lasers: the pigment lasers, vascular lasers, and laser hair removal. Unfortunately, when you use nonablative fractional lasers, there really isn’t an endpoint, so it’s going to be more difficult to discern in that case. The key clinical finding is the endpoint, not the energy setting.”
When treating pigmented lesions and tattoos, for example, immediate whitening is the desired endpoint, not tissue splatter. “So, if you see the epidermis fly off with your first pulse, dial it down,” Dr. Avram said. “It sounds obvious, but sometimes, if you’re working quickly, you figure it will be all right. Just stop and make sure you’re seeing what you’re supposed to be seeing.”
The desired endpoints for vascular lasers, meanwhile, include purpura, transient purpura, or vessel clearance. “What you don’t want to see is gray,” he said. Desired endpoints for hair removal include perifollicular edema and erythema. “What you don’t want to see is epidermal change or dermal tightening,” he added. “Observe the skin and the patient. If the skin is reacting strangely, stop and check all of your settings. If the patient is having an inordinate amount of pain, stop and check all of your settings. These are often the clues that can help you avoid harming a patient.”
Dr. Avram disclosed that he has received consulting fees from Allergan, Merz, Sciton, Soliton, and Zalea. He also reported having ownership and/or shareholder interest in Cytrellis, Invasix, and Zalea.
FROM MOAS 2017
Reduced starting dose of sorafenib for HCC appears safe
Compared with starting patients with hepatocellular carcinoma on a standard dose of sorafenib, reducing the starting dose was associated with reduced treatment costs, yet did not reduce overall survival, a large retrospective analysis showed.
“Our data suggest that the initiation of sorafenib at a reduced dosage may be a safe and reasonable strategy for some patients with HCC,” researchers led by Kim A. Reiss, MD, wrote in the Journal of Oncology.
Dr. Reiss, of the Philadelphia-based Perelman Center for Advanced Medicine, and her associates analyzed data from 4,903 patients with HCC who were prescribed sorafenib at 128 Veterans Health Administration hospitals between January 2006 and April 2015. They used Cox regression analysis to examine the impact of the drug’s starting dose on patient outcomes and cost. The primary endpoint was overall survival of patients who were prescribed a standard starting dose of sorafenib at 800 mg/d, compared with a starting dose of less than 800 mg/d.
The mean age of patients was 62 years, 99% were male, and 61% where white. In an unmatched and unadjusted analysis, the researchers found that compared with patients who received a standard starting dose of sorafenib, those who received a reduced starting dose had more Barcelona Clinic Liver Cancer stage D disease (P less than .001), higher Model for End-Stage Liver Disease Sodium scores (P less than .001), higher Child-Turcotte-Pugh scores (P less than .001), higher Cirrhosis Comorbidity Index scores (P=.01), and a lower overall survival (a median of 200 vs. 233 days, respectively; HR 1.10). However, after propensity score matching and adjustment for potential confounders, the difference in overall survival between the two treatment groups dropped below the noninferiority margin (P less than .001), the investigators reported (J Clin Oncol. 2017 Sept 5 doi.org/10.1200/JCO.2017.73.8245).
In addition, patients who received a reduced starting dose of sorafenib had a significantly lower total cost of the medication ($5,636 vs. $8,661; P less than .001) and were less likely to stop taking sorafenib because of GI effects (8.7% vs. 10.8%; P = .047).
The study was supported by unrestricted research funds from Bayer HealthCare Pharmaceuticals and the VA HIV, Hepatitis, and Related Conditions Programs in the Office of Specialty Care Services. One of the authors, Ronac Mamtani, MD, is supported by National Institutes of Health/National Cancer Institute grant K23CA18718.
Compared with starting patients with hepatocellular carcinoma on a standard dose of sorafenib, reducing the starting dose was associated with reduced treatment costs, yet did not reduce overall survival, a large retrospective analysis showed.
“Our data suggest that the initiation of sorafenib at a reduced dosage may be a safe and reasonable strategy for some patients with HCC,” researchers led by Kim A. Reiss, MD, wrote in the Journal of Oncology.
Dr. Reiss, of the Philadelphia-based Perelman Center for Advanced Medicine, and her associates analyzed data from 4,903 patients with HCC who were prescribed sorafenib at 128 Veterans Health Administration hospitals between January 2006 and April 2015. They used Cox regression analysis to examine the impact of the drug’s starting dose on patient outcomes and cost. The primary endpoint was overall survival of patients who were prescribed a standard starting dose of sorafenib at 800 mg/d, compared with a starting dose of less than 800 mg/d.
The mean age of patients was 62 years, 99% were male, and 61% where white. In an unmatched and unadjusted analysis, the researchers found that compared with patients who received a standard starting dose of sorafenib, those who received a reduced starting dose had more Barcelona Clinic Liver Cancer stage D disease (P less than .001), higher Model for End-Stage Liver Disease Sodium scores (P less than .001), higher Child-Turcotte-Pugh scores (P less than .001), higher Cirrhosis Comorbidity Index scores (P=.01), and a lower overall survival (a median of 200 vs. 233 days, respectively; HR 1.10). However, after propensity score matching and adjustment for potential confounders, the difference in overall survival between the two treatment groups dropped below the noninferiority margin (P less than .001), the investigators reported (J Clin Oncol. 2017 Sept 5 doi.org/10.1200/JCO.2017.73.8245).
In addition, patients who received a reduced starting dose of sorafenib had a significantly lower total cost of the medication ($5,636 vs. $8,661; P less than .001) and were less likely to stop taking sorafenib because of GI effects (8.7% vs. 10.8%; P = .047).
The study was supported by unrestricted research funds from Bayer HealthCare Pharmaceuticals and the VA HIV, Hepatitis, and Related Conditions Programs in the Office of Specialty Care Services. One of the authors, Ronac Mamtani, MD, is supported by National Institutes of Health/National Cancer Institute grant K23CA18718.
Compared with starting patients with hepatocellular carcinoma on a standard dose of sorafenib, reducing the starting dose was associated with reduced treatment costs, yet did not reduce overall survival, a large retrospective analysis showed.
“Our data suggest that the initiation of sorafenib at a reduced dosage may be a safe and reasonable strategy for some patients with HCC,” researchers led by Kim A. Reiss, MD, wrote in the Journal of Oncology.
Dr. Reiss, of the Philadelphia-based Perelman Center for Advanced Medicine, and her associates analyzed data from 4,903 patients with HCC who were prescribed sorafenib at 128 Veterans Health Administration hospitals between January 2006 and April 2015. They used Cox regression analysis to examine the impact of the drug’s starting dose on patient outcomes and cost. The primary endpoint was overall survival of patients who were prescribed a standard starting dose of sorafenib at 800 mg/d, compared with a starting dose of less than 800 mg/d.
The mean age of patients was 62 years, 99% were male, and 61% where white. In an unmatched and unadjusted analysis, the researchers found that compared with patients who received a standard starting dose of sorafenib, those who received a reduced starting dose had more Barcelona Clinic Liver Cancer stage D disease (P less than .001), higher Model for End-Stage Liver Disease Sodium scores (P less than .001), higher Child-Turcotte-Pugh scores (P less than .001), higher Cirrhosis Comorbidity Index scores (P=.01), and a lower overall survival (a median of 200 vs. 233 days, respectively; HR 1.10). However, after propensity score matching and adjustment for potential confounders, the difference in overall survival between the two treatment groups dropped below the noninferiority margin (P less than .001), the investigators reported (J Clin Oncol. 2017 Sept 5 doi.org/10.1200/JCO.2017.73.8245).
In addition, patients who received a reduced starting dose of sorafenib had a significantly lower total cost of the medication ($5,636 vs. $8,661; P less than .001) and were less likely to stop taking sorafenib because of GI effects (8.7% vs. 10.8%; P = .047).
The study was supported by unrestricted research funds from Bayer HealthCare Pharmaceuticals and the VA HIV, Hepatitis, and Related Conditions Programs in the Office of Specialty Care Services. One of the authors, Ronac Mamtani, MD, is supported by National Institutes of Health/National Cancer Institute grant K23CA18718.
FROM THE JOURNAL OF ONCOLOGY
Key clinical point:
Major finding: Patients who received a reduced starting dose of sorafenib had a significantly lower total cost of the medication ($5,636 vs. $8,661; P less than .001) and were less likely to stop taking sorafenib because of GI effects (8.7% vs. 10.8%; P = .047). Overall survival was not significantly different.
Data source: Retrospective data analysis of 4,903 patients from 128 Veterans Health Administration hospitals.
Disclosures: The study was supported by unrestricted research funds from Bayer HealthCare Pharmaceuticals and the VA HIV, Hepatitis, and Related Conditions Programs in the Office of Specialty Care Services. One of the authors, Ronac Mamtani, MD, is supported by National Institutes of Health/National Cancer Institute grant K23CA18718.
Does microneedling have a role in aesthetics?
AT MOAS 2017
SAN DIEGO – When Jill S. Waibel, MD, first saw a dermal roller microneedling device around 2004, it reminded her of a weapon that might be conjured up by the character Dr. Kaufman, a professional assassin who appeared in the 1997 James Bond film, “Tomorrow Never Dies.”
“I’m thinking, that thing looks super painful,” Dr. Waibel said at the annual Masters of Aesthetics Symposium.
Patients seek microneedling treatments to rejuvenate skin; to treat acne scarring, other scars, striae, and rhytides; and to improve pigmentation. Its mechanism of action remains elusive. The hypothesis for microneedling’s effects on superficial rhytides, the wound that it creates induces production of new collagen and that multiple tiny wounds in the skin stimulate the release of various growth factors that play a role in collagen synthesis. When used on atrophic scars, the hypothesis is that microneedling breaks apart collagen bundles in the superficial layer of the dermis while inducing production of collagen. Authors of a recent systematic review on the topic found that the procedure showed noteworthy results on its own, particularly when combined with radio-frequency features (J Plast Reconstr Aesthet Surg. 2017 Jun 17. pii: S1748-6815[17]30250-4. doi: 10.1016/j.bjps.2017.06.006).
“However, there were shortcomings with most of the research: There were small numbers of patients, studies that were not randomized, not controlled, and further research is needed to see if microneedling truly works,” said Dr. Waibel, who was not involved with the analysis.
Microneedling devices come in many forms, including manual rollers, fixed-needle rollers, electric-powered pens, and devices with a new light-emitting microneedling technology. Of the five devices currently cleared by the Food and Drug Administration, four feature bipolar radio frequency and insulated needles, while one is a bipolar radio-frequency device (Infini) that contains noninsulated needles. Dr. Waibel favors the electric-powered pens, such as the StrataPen and the Eclipse MicroPen, that enable the user to adjust operating speed and penetration depths from 0.5 mm-3.0 mm, as well as feature disposable needle tips and disposable needles. These devices allow the depth of penetration to be changed according to what part of the face is being treated: “So on thinner areas of the face, like the forehead and the nose, you’re going to treat with a depth of 0.5 mm-1.0 mm, whereas in thicker areas, like the cheeks, you go up to 3.0 mm,” she said. “Typically, we do vertical and horizontal passes, repeating three to six times. When you see pinpoint bleeding, that’s the sign to stop. You can stop prior to that as well.”
One split-face study compared microneedling with nonablative fractional laser in 30 patients with atrophic scars, who underwent five sessions 1 month apart. (Dermatol Surg 2017; 43:S47-56). At 3 months, the side of the face treated with the laser showed a 70% improvement, compared with 30% for the side treated with microneedling (P less than .001). The researchers observed significantly lower pain scores with the laser procedure, but microneedling had a significantly shorter down time. A separate study of 12 healthy adults found that pretreatment with an ablative fractional laser significantly intensifies protoporphyrin IX fluorescence to a larger extent than curettage, microdermabrasion, microneedling, and nonablative fractional laser (JAMA Derm. 2017;153[4]:270-8). “So the message is that lasers are still superior, but there may be a role for microneedling,” Dr. Waibel said.
Since she began dabbling with microneedling in her practice over the past year, Dr. Waibel has found it is a good option for younger patients and for patients who desire little to no recovery time. “These are not expensive procedures for someone who doesn’t have a lot of skin damage,” she said. “It’s also good for difficult indications to improve, like striae. If I charge patients a few hundred dollars for a laser treatment, maybe I can do two or three follow-ups with the microneedle to stimulate collagen. This has become one of my go-tos with the radio-frequency device. I’ll do one fractional ablative laser treatment, then I’ll do two of the radiofrequency microneedle devices 1 and 2 months later. Then I’ll reassess to see what they need next. Or you might tweak [the course of treatment] after isolated laser treatments.”
Using a microneedle device requires meticulous cleaning of the intended treatment area prior to the procedure to avoid introducing bacteria or makeup into the skin. Dr. Waibel uses topical anesthesia for 20-30 minutes and then applies hyaluronic acid gel on the treatment surface to facilitate the gliding action of the device. “The technique involves perpendicular device placement with manual skin traction for smooth delivery of microneedles, going in vertical, horizontal, and oblique motions,” she explained. “Pinpoint bleeding is your guide for the pens. You don’t get pinpoint bleeding with some of the actual devices. Use manual pressure with ice and water to stop the bleeding.”
Contraindications for microneedling include patients with an active infection (such as herpes labialis), acne, and a predisposition for keloid scarring. Caution is advised with concomitant use of topical products of any type during a microneedling procedure because of the risk of granuloma formation. In 2014, researchers published a case series of three patients who developed biopsy-proven foreign body granulomas after the application of topical products during microneedling, including two cases that involved topical vitamin C (JAMA Dermatol 2014;150[1]:68-72).
“These are new devices, and we have new questions,” Dr. Waibel concluded. “I think they have a role, but we don’t fully understand the mechanism of action, and we have to be very careful about putting pharmacology down these channels. We don’t know the best treatment intervals, and we don’t know the best devices,” she added, pointing out that many of the devices have no indications cleared by the FDA yet.
She also noted that the FDA has put a hold on many microneedling devices from being sold in the United States until appropriate safety and efficacy data are collected.
Dr. Waibel disclosed that she has conducted clinical research for Strata Sciences, Aquavit, and Lutronic. She is also a member of the advisory board for Lutronic.
AT MOAS 2017
SAN DIEGO – When Jill S. Waibel, MD, first saw a dermal roller microneedling device around 2004, it reminded her of a weapon that might be conjured up by the character Dr. Kaufman, a professional assassin who appeared in the 1997 James Bond film, “Tomorrow Never Dies.”
“I’m thinking, that thing looks super painful,” Dr. Waibel said at the annual Masters of Aesthetics Symposium.
Patients seek microneedling treatments to rejuvenate skin; to treat acne scarring, other scars, striae, and rhytides; and to improve pigmentation. Its mechanism of action remains elusive. The hypothesis for microneedling’s effects on superficial rhytides, the wound that it creates induces production of new collagen and that multiple tiny wounds in the skin stimulate the release of various growth factors that play a role in collagen synthesis. When used on atrophic scars, the hypothesis is that microneedling breaks apart collagen bundles in the superficial layer of the dermis while inducing production of collagen. Authors of a recent systematic review on the topic found that the procedure showed noteworthy results on its own, particularly when combined with radio-frequency features (J Plast Reconstr Aesthet Surg. 2017 Jun 17. pii: S1748-6815[17]30250-4. doi: 10.1016/j.bjps.2017.06.006).
“However, there were shortcomings with most of the research: There were small numbers of patients, studies that were not randomized, not controlled, and further research is needed to see if microneedling truly works,” said Dr. Waibel, who was not involved with the analysis.
Microneedling devices come in many forms, including manual rollers, fixed-needle rollers, electric-powered pens, and devices with a new light-emitting microneedling technology. Of the five devices currently cleared by the Food and Drug Administration, four feature bipolar radio frequency and insulated needles, while one is a bipolar radio-frequency device (Infini) that contains noninsulated needles. Dr. Waibel favors the electric-powered pens, such as the StrataPen and the Eclipse MicroPen, that enable the user to adjust operating speed and penetration depths from 0.5 mm-3.0 mm, as well as feature disposable needle tips and disposable needles. These devices allow the depth of penetration to be changed according to what part of the face is being treated: “So on thinner areas of the face, like the forehead and the nose, you’re going to treat with a depth of 0.5 mm-1.0 mm, whereas in thicker areas, like the cheeks, you go up to 3.0 mm,” she said. “Typically, we do vertical and horizontal passes, repeating three to six times. When you see pinpoint bleeding, that’s the sign to stop. You can stop prior to that as well.”
One split-face study compared microneedling with nonablative fractional laser in 30 patients with atrophic scars, who underwent five sessions 1 month apart. (Dermatol Surg 2017; 43:S47-56). At 3 months, the side of the face treated with the laser showed a 70% improvement, compared with 30% for the side treated with microneedling (P less than .001). The researchers observed significantly lower pain scores with the laser procedure, but microneedling had a significantly shorter down time. A separate study of 12 healthy adults found that pretreatment with an ablative fractional laser significantly intensifies protoporphyrin IX fluorescence to a larger extent than curettage, microdermabrasion, microneedling, and nonablative fractional laser (JAMA Derm. 2017;153[4]:270-8). “So the message is that lasers are still superior, but there may be a role for microneedling,” Dr. Waibel said.
Since she began dabbling with microneedling in her practice over the past year, Dr. Waibel has found it is a good option for younger patients and for patients who desire little to no recovery time. “These are not expensive procedures for someone who doesn’t have a lot of skin damage,” she said. “It’s also good for difficult indications to improve, like striae. If I charge patients a few hundred dollars for a laser treatment, maybe I can do two or three follow-ups with the microneedle to stimulate collagen. This has become one of my go-tos with the radio-frequency device. I’ll do one fractional ablative laser treatment, then I’ll do two of the radiofrequency microneedle devices 1 and 2 months later. Then I’ll reassess to see what they need next. Or you might tweak [the course of treatment] after isolated laser treatments.”
Using a microneedle device requires meticulous cleaning of the intended treatment area prior to the procedure to avoid introducing bacteria or makeup into the skin. Dr. Waibel uses topical anesthesia for 20-30 minutes and then applies hyaluronic acid gel on the treatment surface to facilitate the gliding action of the device. “The technique involves perpendicular device placement with manual skin traction for smooth delivery of microneedles, going in vertical, horizontal, and oblique motions,” she explained. “Pinpoint bleeding is your guide for the pens. You don’t get pinpoint bleeding with some of the actual devices. Use manual pressure with ice and water to stop the bleeding.”
Contraindications for microneedling include patients with an active infection (such as herpes labialis), acne, and a predisposition for keloid scarring. Caution is advised with concomitant use of topical products of any type during a microneedling procedure because of the risk of granuloma formation. In 2014, researchers published a case series of three patients who developed biopsy-proven foreign body granulomas after the application of topical products during microneedling, including two cases that involved topical vitamin C (JAMA Dermatol 2014;150[1]:68-72).
“These are new devices, and we have new questions,” Dr. Waibel concluded. “I think they have a role, but we don’t fully understand the mechanism of action, and we have to be very careful about putting pharmacology down these channels. We don’t know the best treatment intervals, and we don’t know the best devices,” she added, pointing out that many of the devices have no indications cleared by the FDA yet.
She also noted that the FDA has put a hold on many microneedling devices from being sold in the United States until appropriate safety and efficacy data are collected.
Dr. Waibel disclosed that she has conducted clinical research for Strata Sciences, Aquavit, and Lutronic. She is also a member of the advisory board for Lutronic.
AT MOAS 2017
SAN DIEGO – When Jill S. Waibel, MD, first saw a dermal roller microneedling device around 2004, it reminded her of a weapon that might be conjured up by the character Dr. Kaufman, a professional assassin who appeared in the 1997 James Bond film, “Tomorrow Never Dies.”
“I’m thinking, that thing looks super painful,” Dr. Waibel said at the annual Masters of Aesthetics Symposium.
Patients seek microneedling treatments to rejuvenate skin; to treat acne scarring, other scars, striae, and rhytides; and to improve pigmentation. Its mechanism of action remains elusive. The hypothesis for microneedling’s effects on superficial rhytides, the wound that it creates induces production of new collagen and that multiple tiny wounds in the skin stimulate the release of various growth factors that play a role in collagen synthesis. When used on atrophic scars, the hypothesis is that microneedling breaks apart collagen bundles in the superficial layer of the dermis while inducing production of collagen. Authors of a recent systematic review on the topic found that the procedure showed noteworthy results on its own, particularly when combined with radio-frequency features (J Plast Reconstr Aesthet Surg. 2017 Jun 17. pii: S1748-6815[17]30250-4. doi: 10.1016/j.bjps.2017.06.006).
“However, there were shortcomings with most of the research: There were small numbers of patients, studies that were not randomized, not controlled, and further research is needed to see if microneedling truly works,” said Dr. Waibel, who was not involved with the analysis.
Microneedling devices come in many forms, including manual rollers, fixed-needle rollers, electric-powered pens, and devices with a new light-emitting microneedling technology. Of the five devices currently cleared by the Food and Drug Administration, four feature bipolar radio frequency and insulated needles, while one is a bipolar radio-frequency device (Infini) that contains noninsulated needles. Dr. Waibel favors the electric-powered pens, such as the StrataPen and the Eclipse MicroPen, that enable the user to adjust operating speed and penetration depths from 0.5 mm-3.0 mm, as well as feature disposable needle tips and disposable needles. These devices allow the depth of penetration to be changed according to what part of the face is being treated: “So on thinner areas of the face, like the forehead and the nose, you’re going to treat with a depth of 0.5 mm-1.0 mm, whereas in thicker areas, like the cheeks, you go up to 3.0 mm,” she said. “Typically, we do vertical and horizontal passes, repeating three to six times. When you see pinpoint bleeding, that’s the sign to stop. You can stop prior to that as well.”
One split-face study compared microneedling with nonablative fractional laser in 30 patients with atrophic scars, who underwent five sessions 1 month apart. (Dermatol Surg 2017; 43:S47-56). At 3 months, the side of the face treated with the laser showed a 70% improvement, compared with 30% for the side treated with microneedling (P less than .001). The researchers observed significantly lower pain scores with the laser procedure, but microneedling had a significantly shorter down time. A separate study of 12 healthy adults found that pretreatment with an ablative fractional laser significantly intensifies protoporphyrin IX fluorescence to a larger extent than curettage, microdermabrasion, microneedling, and nonablative fractional laser (JAMA Derm. 2017;153[4]:270-8). “So the message is that lasers are still superior, but there may be a role for microneedling,” Dr. Waibel said.
Since she began dabbling with microneedling in her practice over the past year, Dr. Waibel has found it is a good option for younger patients and for patients who desire little to no recovery time. “These are not expensive procedures for someone who doesn’t have a lot of skin damage,” she said. “It’s also good for difficult indications to improve, like striae. If I charge patients a few hundred dollars for a laser treatment, maybe I can do two or three follow-ups with the microneedle to stimulate collagen. This has become one of my go-tos with the radio-frequency device. I’ll do one fractional ablative laser treatment, then I’ll do two of the radiofrequency microneedle devices 1 and 2 months later. Then I’ll reassess to see what they need next. Or you might tweak [the course of treatment] after isolated laser treatments.”
Using a microneedle device requires meticulous cleaning of the intended treatment area prior to the procedure to avoid introducing bacteria or makeup into the skin. Dr. Waibel uses topical anesthesia for 20-30 minutes and then applies hyaluronic acid gel on the treatment surface to facilitate the gliding action of the device. “The technique involves perpendicular device placement with manual skin traction for smooth delivery of microneedles, going in vertical, horizontal, and oblique motions,” she explained. “Pinpoint bleeding is your guide for the pens. You don’t get pinpoint bleeding with some of the actual devices. Use manual pressure with ice and water to stop the bleeding.”
Contraindications for microneedling include patients with an active infection (such as herpes labialis), acne, and a predisposition for keloid scarring. Caution is advised with concomitant use of topical products of any type during a microneedling procedure because of the risk of granuloma formation. In 2014, researchers published a case series of three patients who developed biopsy-proven foreign body granulomas after the application of topical products during microneedling, including two cases that involved topical vitamin C (JAMA Dermatol 2014;150[1]:68-72).
“These are new devices, and we have new questions,” Dr. Waibel concluded. “I think they have a role, but we don’t fully understand the mechanism of action, and we have to be very careful about putting pharmacology down these channels. We don’t know the best treatment intervals, and we don’t know the best devices,” she added, pointing out that many of the devices have no indications cleared by the FDA yet.
She also noted that the FDA has put a hold on many microneedling devices from being sold in the United States until appropriate safety and efficacy data are collected.
Dr. Waibel disclosed that she has conducted clinical research for Strata Sciences, Aquavit, and Lutronic. She is also a member of the advisory board for Lutronic.
Light alcohol use did not affect liver fibrosis progression in HIV/HCV-coinfected women
Women coinfected with HIV and hepatitis C virus who drank light and moderate amounts of alcohol did not experience significant progression of liver fibrosis, compared with those who drank heavily, results from a large cohort study found.
“Although heavy alcohol use is clearly detrimental to the health of patients with CHC [chronic hepatitis C], it is unclear whether consumption of smaller quantities of alcohol impact fibrosis progression,” researchers led by Erin M. Kelly, MD, wrote in a study published online Aug. 16 in Clinical Infectious Diseases (doi: 10.1093/cid/cix716). “Many patients with CHC consume alcohol and are unable or unwilling to completely abstain. Some studies have suggested a linear dose-response relationship for fibrosis progression even at lower quantities, while others have not clearly demonstrated a risk for fibrosis progression below 20-50 g of alcohol per day. HIV/HCV [hepatitis C virus]-coinfected patients have accelerated fibrosis progression, compared with HCV monoinfected individuals. Whether regular consumption of small quantities of alcohol further increase the rate of fibrosis progression is unknown.”
At baseline, the mean age of study participants was 40 years, their mean body mass index was 26 kg/m2, 17% had diabetes, and 11% had significant fibrosis, defined as a FIB-4 index of greater than 3.25. Nearly half (46%) reported no alcohol use; 26.8% reported light use; 7.1%, moderate use; and 19.7%, heavy use. The median FIB-4 scores at entry were similar between groups. On multivariable analysis, no significant difference in fibrosis progression was observed in abstainers, compared with those who reported light and moderate alcohol use (0.004 and 0.006 FIB-4 units/year, respectively). On the other hand, those who reported very heavy drinking showed significant fibrosis acceleration, compared with abstainers (0.25 FIB-4 units/year), while those who reported drinking 8-14 drinks per week showed minimal acceleration of fibrosis progression (0.04 FIB-4 units/year).
“Of interest, despite WIHS research clinicians recommending limiting or avoiding alcohol at semiannual visits, most women who consumed alcohol at WIHS entry continued to have periods of alcohol use in follow-up,” Dr. Kelly and her associates wrote. “This suggests that, despite being enrolled in a long-term observational cohort study, patients did not change their drinking behaviors, limiting any potential bias in changing behaviors due to participation in a research study.”
The investigators acknowledged certain limitations of the study, including the fact that while current alcohol use was captured at study entry and at follow-up, lifetime alcohol exposure was not collected. “Women categorized as abstinent may have had a prior history of alcohol use,” they noted. “Some of these women may represent ‘sick abstainers’ that have ceased alcohol consumption due to the severity of their liver disease. This may explain the finding that entry fibrosis scores were similar between groups, when one would expect heavy users to have higher fibrosis scores, as compared to abstinent patients.”
The study was supported by the National Institute of Allergy and Infectious Diseases, with additional cofunding from the National Institute of Child Health and Human Development; the National Cancer Institute; the National Institute on Drug Abuse; the National Institute on Mental Health; and the University of California, San Francisco, Liver Center Biostatistics Core. The researchers reported having no financial disclosures.
This study highlights the importance of assessing alcohol consumption during routine practice (for example, with the Alcohol Use Disorders Identification Test) to classify patients’ level of use. HIV/HCV-coinfected women should be counseled to minimize alcohol consumption, and any patient with evidence of advanced hepatic fibrosis/cirrhosis should avoid alcohol use, given that the risk of liver complications, such as decompensated cirrhosis and hepatocellular carcinoma, associated with light or moderate use remains unknown in this group. However, some may be unable or unwilling to completely abstain from alcohol because of mental health or substance use disorders. This study suggests that light or moderate alcohol use by coinfected women is not associated with accelerated liver fibrosis progression, as measured by changes in the FIB-4 score.
Future studies should determine the effects of light and moderate alcohol consumption on changes in other noninvasive measures of liver fibrosis, such as transient elastography, and on rates of liver complications, such as hepatic decompensation and hepatocellular carcinoma, in HIV/HCV-coinfected men and women to confirm this study’s findings. Additional research also is needed to evaluate the effects of alcohol use categories on adherence to direct-acting antiviral therapy and HCV treatment response to examine whether these outcomes differ by HIV status and sex. These data will further help inform whether there is a “safe” level of alcohol intake in HIV/HCV patients.
This text is taken from a commentary published online Aug. 16 in Clinical Infectious Diseases (doi: 10.1093/cid/cix720). Vincent Lo Re III, MD, MSCE, is with the Center for Clinical Epidemiology and Biostatistics at the University of Pennsylvania, Philadelphia. He disclosed having received research grant support from the University of Pennsylvania, the National Cancer Institute, the National Institute of Allergy and Infectious Diseases, and AstraZeneca.
This study highlights the importance of assessing alcohol consumption during routine practice (for example, with the Alcohol Use Disorders Identification Test) to classify patients’ level of use. HIV/HCV-coinfected women should be counseled to minimize alcohol consumption, and any patient with evidence of advanced hepatic fibrosis/cirrhosis should avoid alcohol use, given that the risk of liver complications, such as decompensated cirrhosis and hepatocellular carcinoma, associated with light or moderate use remains unknown in this group. However, some may be unable or unwilling to completely abstain from alcohol because of mental health or substance use disorders. This study suggests that light or moderate alcohol use by coinfected women is not associated with accelerated liver fibrosis progression, as measured by changes in the FIB-4 score.
Future studies should determine the effects of light and moderate alcohol consumption on changes in other noninvasive measures of liver fibrosis, such as transient elastography, and on rates of liver complications, such as hepatic decompensation and hepatocellular carcinoma, in HIV/HCV-coinfected men and women to confirm this study’s findings. Additional research also is needed to evaluate the effects of alcohol use categories on adherence to direct-acting antiviral therapy and HCV treatment response to examine whether these outcomes differ by HIV status and sex. These data will further help inform whether there is a “safe” level of alcohol intake in HIV/HCV patients.
This text is taken from a commentary published online Aug. 16 in Clinical Infectious Diseases (doi: 10.1093/cid/cix720). Vincent Lo Re III, MD, MSCE, is with the Center for Clinical Epidemiology and Biostatistics at the University of Pennsylvania, Philadelphia. He disclosed having received research grant support from the University of Pennsylvania, the National Cancer Institute, the National Institute of Allergy and Infectious Diseases, and AstraZeneca.
This study highlights the importance of assessing alcohol consumption during routine practice (for example, with the Alcohol Use Disorders Identification Test) to classify patients’ level of use. HIV/HCV-coinfected women should be counseled to minimize alcohol consumption, and any patient with evidence of advanced hepatic fibrosis/cirrhosis should avoid alcohol use, given that the risk of liver complications, such as decompensated cirrhosis and hepatocellular carcinoma, associated with light or moderate use remains unknown in this group. However, some may be unable or unwilling to completely abstain from alcohol because of mental health or substance use disorders. This study suggests that light or moderate alcohol use by coinfected women is not associated with accelerated liver fibrosis progression, as measured by changes in the FIB-4 score.
Future studies should determine the effects of light and moderate alcohol consumption on changes in other noninvasive measures of liver fibrosis, such as transient elastography, and on rates of liver complications, such as hepatic decompensation and hepatocellular carcinoma, in HIV/HCV-coinfected men and women to confirm this study’s findings. Additional research also is needed to evaluate the effects of alcohol use categories on adherence to direct-acting antiviral therapy and HCV treatment response to examine whether these outcomes differ by HIV status and sex. These data will further help inform whether there is a “safe” level of alcohol intake in HIV/HCV patients.
This text is taken from a commentary published online Aug. 16 in Clinical Infectious Diseases (doi: 10.1093/cid/cix720). Vincent Lo Re III, MD, MSCE, is with the Center for Clinical Epidemiology and Biostatistics at the University of Pennsylvania, Philadelphia. He disclosed having received research grant support from the University of Pennsylvania, the National Cancer Institute, the National Institute of Allergy and Infectious Diseases, and AstraZeneca.
Women coinfected with HIV and hepatitis C virus who drank light and moderate amounts of alcohol did not experience significant progression of liver fibrosis, compared with those who drank heavily, results from a large cohort study found.
“Although heavy alcohol use is clearly detrimental to the health of patients with CHC [chronic hepatitis C], it is unclear whether consumption of smaller quantities of alcohol impact fibrosis progression,” researchers led by Erin M. Kelly, MD, wrote in a study published online Aug. 16 in Clinical Infectious Diseases (doi: 10.1093/cid/cix716). “Many patients with CHC consume alcohol and are unable or unwilling to completely abstain. Some studies have suggested a linear dose-response relationship for fibrosis progression even at lower quantities, while others have not clearly demonstrated a risk for fibrosis progression below 20-50 g of alcohol per day. HIV/HCV [hepatitis C virus]-coinfected patients have accelerated fibrosis progression, compared with HCV monoinfected individuals. Whether regular consumption of small quantities of alcohol further increase the rate of fibrosis progression is unknown.”
At baseline, the mean age of study participants was 40 years, their mean body mass index was 26 kg/m2, 17% had diabetes, and 11% had significant fibrosis, defined as a FIB-4 index of greater than 3.25. Nearly half (46%) reported no alcohol use; 26.8% reported light use; 7.1%, moderate use; and 19.7%, heavy use. The median FIB-4 scores at entry were similar between groups. On multivariable analysis, no significant difference in fibrosis progression was observed in abstainers, compared with those who reported light and moderate alcohol use (0.004 and 0.006 FIB-4 units/year, respectively). On the other hand, those who reported very heavy drinking showed significant fibrosis acceleration, compared with abstainers (0.25 FIB-4 units/year), while those who reported drinking 8-14 drinks per week showed minimal acceleration of fibrosis progression (0.04 FIB-4 units/year).
“Of interest, despite WIHS research clinicians recommending limiting or avoiding alcohol at semiannual visits, most women who consumed alcohol at WIHS entry continued to have periods of alcohol use in follow-up,” Dr. Kelly and her associates wrote. “This suggests that, despite being enrolled in a long-term observational cohort study, patients did not change their drinking behaviors, limiting any potential bias in changing behaviors due to participation in a research study.”
The investigators acknowledged certain limitations of the study, including the fact that while current alcohol use was captured at study entry and at follow-up, lifetime alcohol exposure was not collected. “Women categorized as abstinent may have had a prior history of alcohol use,” they noted. “Some of these women may represent ‘sick abstainers’ that have ceased alcohol consumption due to the severity of their liver disease. This may explain the finding that entry fibrosis scores were similar between groups, when one would expect heavy users to have higher fibrosis scores, as compared to abstinent patients.”
The study was supported by the National Institute of Allergy and Infectious Diseases, with additional cofunding from the National Institute of Child Health and Human Development; the National Cancer Institute; the National Institute on Drug Abuse; the National Institute on Mental Health; and the University of California, San Francisco, Liver Center Biostatistics Core. The researchers reported having no financial disclosures.
Women coinfected with HIV and hepatitis C virus who drank light and moderate amounts of alcohol did not experience significant progression of liver fibrosis, compared with those who drank heavily, results from a large cohort study found.
“Although heavy alcohol use is clearly detrimental to the health of patients with CHC [chronic hepatitis C], it is unclear whether consumption of smaller quantities of alcohol impact fibrosis progression,” researchers led by Erin M. Kelly, MD, wrote in a study published online Aug. 16 in Clinical Infectious Diseases (doi: 10.1093/cid/cix716). “Many patients with CHC consume alcohol and are unable or unwilling to completely abstain. Some studies have suggested a linear dose-response relationship for fibrosis progression even at lower quantities, while others have not clearly demonstrated a risk for fibrosis progression below 20-50 g of alcohol per day. HIV/HCV [hepatitis C virus]-coinfected patients have accelerated fibrosis progression, compared with HCV monoinfected individuals. Whether regular consumption of small quantities of alcohol further increase the rate of fibrosis progression is unknown.”
At baseline, the mean age of study participants was 40 years, their mean body mass index was 26 kg/m2, 17% had diabetes, and 11% had significant fibrosis, defined as a FIB-4 index of greater than 3.25. Nearly half (46%) reported no alcohol use; 26.8% reported light use; 7.1%, moderate use; and 19.7%, heavy use. The median FIB-4 scores at entry were similar between groups. On multivariable analysis, no significant difference in fibrosis progression was observed in abstainers, compared with those who reported light and moderate alcohol use (0.004 and 0.006 FIB-4 units/year, respectively). On the other hand, those who reported very heavy drinking showed significant fibrosis acceleration, compared with abstainers (0.25 FIB-4 units/year), while those who reported drinking 8-14 drinks per week showed minimal acceleration of fibrosis progression (0.04 FIB-4 units/year).
“Of interest, despite WIHS research clinicians recommending limiting or avoiding alcohol at semiannual visits, most women who consumed alcohol at WIHS entry continued to have periods of alcohol use in follow-up,” Dr. Kelly and her associates wrote. “This suggests that, despite being enrolled in a long-term observational cohort study, patients did not change their drinking behaviors, limiting any potential bias in changing behaviors due to participation in a research study.”
The investigators acknowledged certain limitations of the study, including the fact that while current alcohol use was captured at study entry and at follow-up, lifetime alcohol exposure was not collected. “Women categorized as abstinent may have had a prior history of alcohol use,” they noted. “Some of these women may represent ‘sick abstainers’ that have ceased alcohol consumption due to the severity of their liver disease. This may explain the finding that entry fibrosis scores were similar between groups, when one would expect heavy users to have higher fibrosis scores, as compared to abstinent patients.”
The study was supported by the National Institute of Allergy and Infectious Diseases, with additional cofunding from the National Institute of Child Health and Human Development; the National Cancer Institute; the National Institute on Drug Abuse; the National Institute on Mental Health; and the University of California, San Francisco, Liver Center Biostatistics Core. The researchers reported having no financial disclosures.
FROM CLINICAL INFECTIOUS DISEASES
Key clinical point:
Major finding: On multivariable analysis, no significant difference in fibrosis progression was observed in abstainers, compared with those who reported light and moderate alcohol use (0.004 and 0.006 FIB-4 units/year, respectively).
Data source: A cohort study of 686 participants in the multicenter Women’s Interagency HIV Study.
Disclosures: The study was supported by the National Institute of Allergy and Infectious Diseases, with additional cofunding from the National Institute of Child Health and Human Development, the National Cancer Institute, the National Institute on Drug Abuse, the National Institute on Mental Health, and the UCSF Liver Center Biostatistics Core. The researchers reported having no financial disclosures.