Recent Developments
Gist Right: Five Leading Dermatologists Balance Education and Engagement in New Web Series
Five leading dermatologists are taking on social media misinformation one YouTube video at a time. Doris Day, MD; Jeanine Downie, MD; Sabrina Fabi, MD; Ava Shamban, MD; and Ruth Tedaldi, MD are the faces—and the brains—of “The Gist,” a new web series aimed at giving dermatology patients the facts about aesthetic and medical conditions and treatments.
“We were constantly seeing lots of social media presence that is not accurate or expert in nature. We talk about it all the time,” says Dr. Tedaldi. The physicians wanted to find a way to reach the masses with facts and science, rather than hype. The concept of a web-based discussion format program was born.
“We were very motivated and very excited,” Dr. Tedaldi says. “Really what we want to do is open the field of aesthetic medicine.”
“We want to take the fright factor out of cosmetic dermatology,” adds Dr. Downie.
The team knew that producing the series would require more resources than they could muster. They approached Allergan, and the company agreed to support the program to grow the market for everyone as a non-branded venue.
“We want to be a credible source,” says Dr. Fabi. “To offer a space that I think right now is just full of sensationalism.”
The panelists note that they bring a diversity of experience and opinions to each conversation. “We’re a broad group. We have a lot of research, education, and experience under our belt. We have publications. We all teach,” Dr. Day notes. “The unanimous, really truly overwhelming response has been extremely positive.”
Colleagues, “want to know how to help us. They want to know how to support us. So we’re telling everybody to go to YouTube.com/thegistshow and subscribe and like us,” Dr. Downie says.
The talk-show style format, which resonates with viewers and adds unique value, Dr. Shamban suggests. “You get the benefit of having not just one opinion; you have the five opinions. It’s very difficult to go see even one dermatologist, but to be able to have access to five very educated dermatologists?”
The panelists may not always reach consensus, but viewers “can find the truth somewhere in between,” Dr. Downie offers.
Ultimately, the dermatologists of “The Gist” want to elevate the specialty and its many facets, including both medical and cosmetic dermatology. New features will be added to the program over time, and additional expert guests will participate.
“We’re in this to represent our specialty and to make sure we claim and maintain the respect and status we deserve,” Dr. Day insists.
“We’re empowering the physician, because we’re all in the same boat,” Dr. Fabi states. “We’re all dealing with the same types of people encroaching into our space that may not have the level of education and training that we do…I think that we’re basically the voice of many people. It’s not just our own.”
Consumers Cite Dermatologists as Top Influencers of Cosmetic Procedure, SkinCare Choices: ASDS
When it comes to consumer decisions on cosmetic procedures and skincare choices, dermatologists are the leading influencers, results of the 2019 American Society for Dermatologic Surgery (ASDS) Consumer Survey on Cosmetic Dermatologic Procedures suggest.
Consumers also rated dermatologists as the top resource for skincare product decisions and physician of choice in five of 10 treatment categories, including injectable wrinkle-relaxers; soft-tissue fillers; laser/light therapy for skin redness, tone, and scars; vein treatments; and tattoo removal.
In selecting a practitioner, the specialty in which the physician is board certified and the level of the physician’s licensure ranked as primary influencing factors. More than 60 percent of the dermatologists seen by survey respondents are ASDS members.
Consumers’ strong interest in cosmetic procedures continues this year with almost 70 percent of consumers considering a cosmetic treatment. Excess weight (84 percent), excessive fat under the chin (73 percent), skin texture and/or discoloration (71 percent), and lines and wrinkles around or under the eyes (70 percent) have consistently been their leading concerns for five years in a row. The desires to feel more confident, appear more attractive, look as young as they feel, and do something for themselves were the primary motivations behind exploring cosmetic procedures.
The top five treatments and percentage of consumers considering them are:
- Body sculpting, 58 percent
- Ultrasound, laser, light, and radio frequency treatments for smoothing wrinkles or tightening skin, 56 percent
- Laser hair removal, 51 percent
- Microdermabrasion, 51 percent
- Injectable wrinkle relaxer, 47 percent
Online resources and social media are impacting consumers’ selection of their provider, cosmetic procedure and skincare purchases. Social media ranked in the top three factors in buying decisions for skincare products and ranked sixth among factors influencing the decision to have a cosmetic treatment. A provider’s social media presence influenced 43 percent of consumers’ decisions to schedule an appointment, and 41 percent of patients follow their current or potential provider on social media. Influencers and celebrities have the largest portion of consumer attention with 95 percent following, viewing, and engaging in their content.
Consumers are also seeking information on previous patients’ experiences by utilizing rate and review websites. These resources impact 69 percent of consumers on their decision for a cosmetic procedure provider. Top sites visited are: WebMD (20 percent); Facebook (12 percent); Physician website (11 percent); Yelp (11 percent); and Healthgrades (10 percent).
Good Oral Health and Diet May Improve Psoriasis
Dental health and diet may have an impact on the development and severity of psoriasis, according to researchers from The Ohio State University Wexner Medical Center in Columbus.
The study, published in the Dermatology Online Journal, found psoriasis patients who rated their gum health as poor or very poor exhibited significantly more severe psoriasis symptoms than those with healthy gums. Conversely, patients who reported consuming fresh fruit at least once a day experienced milder psoriasis symptoms.
“Psoriasis is an autoimmune disease so although it often presents as red, scaly patches on the skin, we know that the causes and consequences are more than skin deep,” says Benjamin Kaffenberger, MD, a dermatologist at the Ohio State Wexner Medical Center who led the study. “We’re looking for some sort of trigger that sets off the immune system. Because strep throat is one of the known triggers and the microbiome of bacteria in the mouth is much more complex, that became our starting point. We wondered if poor dental health could be a risk factor for psoriasis.”
Researchers created a specially designed lifestyle and diet questionnaire that was administered to 265 patients at Ohio State’s dermatology clinics. The study surveyed 100 patients with psoriasis and 165 without the disease. The study showed poor dental and oral health, in particular gum pain, was associated with those who had psoriasis.
“Patients who had more severe psoriasis were more likely to report that their gums were in worse condition than patients who didn’t have mild to moderate psoriasis in the first place,” says Dr. Kaffenberger. “And patients who had higher fruit consumption reported less significant psoriasis, indicating fruit and potentially fresh foods may be an associated protective factor.”
The study also reinforced data from previous studies that found family history of psoriasis, smoking and obesity were significant predictors of psoriasis.
Dr. Kaffenberger hopes to expand the study outside Ohio State’s dermatology clinics and survey thousands of psoriasis patients with varying degrees of the disease. While Dr. Kaffenberger noted that the study’s results were very preliminary, he believes having dermatologists screen for dental health and counsel psoriasis patients for improved dietary health may help them.
Second Phase 3 Study Shows Aclaris’ A-101 45% May Help Thwart Common Warts
Aclaris Therapeutics, Inc.’s A-101 45% Topical Solution (A-101 45%), an investigational proprietary high-concentration hydrogen peroxide topical solution for the potential treatment of common warts, performed well in its second Phase 3 clinical trial, THWART-1 (WART-301).
A-101 45% met the primary and all secondary efficacy endpoints, achieving clinically meaningful and statistically significant clearance of common warts.
THWART-1 is the second of two Phase 3 pivotal trials: THWART-1 and THWART-2 (WART-301 and WART-302, respectively). The two randomized, double-blind, vehicle-controlled trials were designed to evaluate the efficacy and safety of A-101 45% as compared to placebo (vehicle) for the treatment of common warts when applied by subjects (or the parents/guardians of subjects < 18 years).
The THWART-1 trial randomized 503 subjects who self-administered either A-101 45% or vehicle twice a week over 8 weeks, for a total of 16 treatments. Each subject had one to six common warts at baseline. The trial achieved its primary endpoint with a high degree of statistical significance, i.e. a higher proportion of subjects treated with A-101 45% versus vehicle had all their identified common warts reported as clear at day 60. Warts were assessed using the Physician Wart Assessment scale, a validated four-point scale of the investigators’ assessment of the severity of all treated common warts (PWA=0 means clear). All secondary efficacy endpoints also achieved statistical significance in favor of A-101 45% versus vehicle.
The safety data from THWART-1 trial was comparable to that of the THWART-2 trial.
Galderma Will Begin Seven Clinical Studies
Galderma is initiating seven clinical studies that seek to support potential, new aesthetic indications including a tear trough indication for Restylane, a facial wrinkles indication for Sculptra Aesthetic as well as several studies supporting an investigational liquid neurotoxin, and a Phase 2 study to evaluate Dysport (abobotulinumtoxinA) for injection in the platysmal bands, the company reports
“Our comprehensive clinical research program is backed by a robust investment plan to support innovation over the next five years,” says Xiaoming Lin, Global Head of Aesthetic Development at Galderma, in a news release. “Globally, Galderma currently has enrolled more than 6,000 patients across approximately 80 clinical trial sites with a total of 17 clinical studies underway.”
Arcutis Biotherapeutics Plans to Initiate Phase 3 Program for ARQ-151 for Psoriasis
Following its End-of-Phase 2 meeting with the FDA, Arcutis Biotherapeutics, Inc. will initiate a Phase 3 program of ARQ-151 as a potential topical treatment for plaque psoriasis.
“We appreciate the collaborative interaction with the FDA to reach agreement on the key elements of our Phase 3 program that we intend to use to support the submission of a New Drug Application for ARQ-151 for plaque psoriasis,” says Frank Watanabe, Arcutis’ President and Chief Executive Officer. “Based on our clinical data to date, we believe ARQ-151 has the potential to be both a best-in-class topical PDE4 inhibitor and the only topical PDE4 inhibitor approved for plaque psoriasis. We look forward to starting our Phase 3 program in the first half of next year.”
The company also announced that it has completed enrollment of a 52-week Phase 2 long-term safety study of ARQ-151 in plaque psoriasis. Topline results are expected in the first half of 2021. The company expects this study to supply the 12-month safety data required for regulatory submissions. In the previous Phase 2b trial in plaque psoriasis, both tested doses of ARQ-151 were well tolerated and demonstrated rapid onset of effect with statistically significant superiority over vehicle. ARQ-151 is a topical cream formulation of roflumilast, a highly potent and selective Phosphodiesterase type 4 (PDE4) inhibitor, which the company is developing for once-a-day application to treat plaque psoriasis and atopic dermatitis.
The ARQ-151-202 study is a Phase 2, multi-center, open-label study of the long-term safety of ARQ-151 0.3% cream in adult subjects with chronic plaque psoriasis involving up to 25% total body surface area (BSA), evaluated in two cohorts: 231 patients who have completed the ARQ-151-201 Phase 2b, randomized, controlled trial; and 102 previously untreated subjects. The qualifying subjects will apply ARQ-151 0.3% cream once daily for 52 weeks at home. Periodic clinic visits will include assessments for clinical safety, application site reactions, and disease improvement or progression. The primary outcome measures of the study are the occurrence of treatment-emergent adverse events and the occurrence of serious adverse events.
CLOSE UP with Mark G. Lebwohl, MD
With so many biologic drugs already approved for treating psoriasis and even more on the way, an emphasis has been placed on how to best distinguish one from another in terms of key attributes, such as durability of response, explains Mark G. Lebwohl, MD, Waldman Chair of Dermatology at the Icahn School of Medicine at Mount Sinai in New York City. Dr. Lebwohl and colleagues recently completed an open-label, Phase 2 study looking at the efficacy, safety, and patient-reported outcomes in patients with moderate to severe plaque psoriasis who were treated with brodalumab (Siliq, Ortho Dermatologics) for five years. They found that brodalumab demonstrated skin clearance and improved quality of life, with an acceptable safety profile, throughout five years of treatment. Their findings were published in September 2019 issue of the American Journal of Clinical Dermatology. Dr. Lebwohl discussed the results of this study with Practical Dermatology® magazine.
WHY IS THIS TOPIC IMPORTANT TO STUDY?
Dr. Lebwohl: There are currently 11 biologic therapies approved for psoriasis with more on the way. Each of them has positive and negative attributes. One of the most important attributes is the durability of response. If patients remain on treatment, do they continue to respond long term? Certainly for some of our therapies, responses are lost, possibly because of the development of antibodies to the drug or simply for other reasons that are less well understood.
DESCRIBE THE RESEARCH AND YOUR FINDINGS.
Dr. Lebwohl: One hundred eighty one patients were treated with brodalumab for a median of 264 weeks. Sixty three percent achieved a score of clear or almost clear skin as early as week two. By week 12, 90.3 percent had achieved clear or almost clear skin. Fully 77.3 percent of patients maintained that level of response through week 240. By week 8, 94.9 percent of patients had achieved Psoriasis Area and Severity Index (PASI) 75, and that was maintained in more than 80 percent of patients through week 264. PASI-100 was achieved by 64 percent of patients by week 8, and 43.4 percent by week 264. These dramatic improvements correlated with Dermatology Quality of Life scores of 0 or 1.
WHAT IS THE NEXT STEP?
Dr. Lebwohl: Difficult-to-treat patients like those who have failed many biologics or those who are obese have been successfully treated with brodalumab, and those data should be obtained from all brodalumab studies to demonstrate the extraordinary efficacy of this therapy.
FDA Approves Amzeeq Minocycline Foam
The FDA has approved Amzeeq (minocycline) topical foam 4%, from Foamix Pharmaceuticals for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in adults and pediatric patients 9 years of age and older. Amzeeq, formerly known as FMX101, is the first topical minocycline to be approved by the FDA for any condition. It is expected to be available January 2020.
The approval is supported by data from three Phase 3 clinical trials in 2,418 patients nine years of age or older. In each 12-week, multicenter, randomized, double-blind, vehicle-controlled study, subjects with moderate to severe acne vulgaris were treated once-daily with Amzeeq or vehicle. No other topical or systemic acne medication was permitted to be used by subjects during the study period. The studies each found statistically significant disease improvement with Amzeeq versus vehicle for the co-primary endpoint of absolute reduction of inflammatory lesions, while studies 2 and 3 demonstrated a statistically significant improvement in IGA treatment success. IGA treatment success was defined as a score of 0 (“clear”) or 1 (“almost clear”) and at least a two-point decrease from baseline. Amzeeq was well-tolerated and no treatment-related serious adverse events were reported. The most common adverse reaction was headache, which was reported in 3% of subjects treated with Amzeeq versus 2% of subjects treated with vehicle.
Amzeeq utilizes the proprietary Molecule Stabilizing Technology (MST™) platform from Foamix to effectively deliver minocycline in a foam-based vehicle.
UCB Presents New Data for Cimzia, Investigational Bimekizumab
Data on the use of UCB’s Cimzia (certolizumab pegol), in psoriasis and psoriatic arthritis (PsA) as well as Phase 2 data for the company’s investigational molecule bimekizumab, were presented at the 28th European Academy of Dermatology and Venereology congress (EADV) in Madrid. Cimzia is a Fc-free anti-TNF treatment. Bimekizumab is a novel humanized monoclonal IgG1 antibody that potently and selectively neutralizes both IL-17A and IL-17F cytokines.
Reflecting UCB’s efforts to better understand the impact of psoriasis on patients, and the unique needs of women, UCB also presented new results from a sample of almost 90,000 respondents of the World Psoriasis Happiness Surveys. These findings highlight gender as a strong predictor of psychological and social well-being in people living with psoriasis and PsA, more so than geographies. The analysis illustrates how psoriasis and PsA can negatively affect women more than men when it comes to life satisfaction, loneliness, mood and self-esteem. Worse life satisfaction, stress, loneliness and isolation were felt most in young women with psoriasis.
New Cimzia three-year efficacy data in plaque psoriasis from a pooled analysis of the completed CIMPASI-1 and CIMPASI-2 open-label extension Phase 3 studies were presented as an oral presentation. Additional pooled results from these trials include Cimzia 48-week sustained efficacy data in psoriasis of the head and neck, areas where disease manifestations can cause high degrees of emotional distress, particularly for female patients.
New 60-week data on novel investigational molecule bimekizumab, from the BE ABLE Phase 2 clinical development program, show rapid and sustained improvements in quality of life (as measured by the Dermatology Life Quality Index), which positively associate with clinical outcomes in patients with moderate-to-severe plaque psoriasis. Positive scalp and nail disease outcomes at 60 weeks were also presented, further supporting bimekizumab’s potential.
Dermira Shares Positive Data From Phase 2b Study of Lebrikizumab for Atopic Dermatitis
Primary results from Dermira, Inc.’s Phase 2b dose-ranging study of lebrikizumab were presented during the 39th Annual Fall Clinical Dermatology Conference in Las Vegas. Lebrikizumab is currently being evaluated in a Phase 3 program in adult and adolescent patients with moderate-to-severe atopic dermatitis.
Lebrikizumab is a novel, investigational, monoclonal antibody designed to bind IL-13 with very high affinity, specifically preventing the formation of the IL-13Rα1/IL-4Rα heterodimer complex and subsequent signaling, thereby inhibiting the biological effects of IL-13 in a targeted and efficient fashion. IL-13 is believed to be a central pathogenic mediator that drives multiple aspects of the pathophysiology underlying the range of signs and symptoms of atopic dermatitis by promoting type 2 inflammation and mediating its effects on tissue, resulting in skin barrier dysfunction, itch, skin thickening, and infection.
“These results are encouraging and suggest that lebrikizumab has the potential to advance the standard of care for patients with moderate-to-severe atopic dermatitis by delivering improvements in efficacy, tolerability, and convenience relative to available therapies,” says April W. Armstrong, MD, MPH, professor of dermatology and associate dean of clinical research at the University of Southern California Keck School of Medicine, and an investigator in the lebrikizumab study. “In this study, lebrikizumab administered once every two or four weeks demonstrated robust, broad efficacy with a safety profile consistent with the substantial prior experience with this and other biologics targeting the IL-4/-13 pathway. Among these encouraging results, I am particularly excited about the impact of lebrikizumab on itch, which is one of the most burdensome symptoms for many atopic dermatitis patients.”
Data Show Long-term Benefit for Sun’s Ilumya
Long-term follow-up data from Ilumya (tildrakizumab-asmn) Phase 3 reSURFACE 1 and 2 trials showed that the significant response rates seen in the initial 52 and 64 weeks, respectively, were maintained over four years for people with moderate to severe plaque psoriasis. More than half of participants achieved at least 90 percent skin clearance (Psoriasis Area Sensitivity Index (PASI) 90) and no new safety concerns were recorded. Results were presented at the 28th European Academy of Dermatology and Venereology Congress (EADV) in Madrid.
Additional study analyses showed that the 75 to 100 percent skin clearance achieved with ILUMYA (Sun Pharma) treatment over three years was sustained equally in people with and without metabolic syndrome.
Also, a study published in the Journal of the European Academy of Dermatology and Venereology assessed the efficacy of Ilumya and the impact on quality of life. It found that PASI responses among week‐28 PASI response groups could be differentiated as early as week 8, that week-28 PASI improvements were sustained or improved through week 52, and that week 28 PASI improvement level correlated with quality of life improvement.
Verrica Pharmaceuticals: Positive Data for VP-102 for Molluscum Contagiosum, Warts
Positive data for VP-102 (cantharidin 0.7% Topical Solution) from Verrica Pharmaceuticals, Inc. was presented in poster form at the Annual Fall Clinical Dermatology Conference in Las Vegas. The company’s lead product candidate is being developed for the treatment of molluscum contagiosum and common warts.
Data from a pooled analysis of the Phase 3 CAMP-1 and CAMP-2 clinical studies showed that treatment with VP-102 brought about a statistically significantly higher rate of complete lesion clearance at Day 84 (primary endpoint) compared to vehicle. Complete clearance of all molluscum lesions at the end of study (EOS) visit occurred in 50 percent of subjects treated with VP-102, as compared to 15.6 percent for vehicle (p<0.0001). In addition, mean lesion counts decreased by 76 percnet for subjects in the VP-102 group, compared to a 0.3 percent decrease in the vehicle arm by the EOS visit (p<0.0001).
VP-102 was well-tolerated; adverse events were primarily mild to moderate in intensity, with the most common adverse events related to the pharmacodynamic action of cantharidin, including application site vesicles, pruritus, pain, erythema, and scab. Rates of discontinuation of study medication due to an adverse event were low.
A second pooled analysis of the CAMP studies evaluated the time course and percentage of subjects with >75 percent and >90 percent reduction in lesions at the EOS visit in the intent-to-treat population. At EOS, 77.7 percent of VP-102 subjects achieved >75 percent reduction in lesions compared to 34.9 percent for vehicle, and 65.8 percent of VP-102 subjects achieved >90 percent reduction of lesions compared to 27.1% for vehicle (p<0.0001 respectively).
Altreno: Exclusive Size Available for Dermatologist Dispensing
Altreno (tretinoin) Lotion, 0.05%, is now available exclusively for physician dispensing in a 20-gram size. Launched last year, Altreno Lotion from Ortho Dermatologics is the first tretinoin available in a lotion for the treatment of acne that has been shown to be effective and generally well tolerated.
Dispensing through dermatologists’ offices allows dermatologists to provide patients Altreno Lotion right at the time of their appointment, avoiding issues with prescriptions not get filled due to cost or inconvenience.
“We like having a derm-dispensed option in our office,” says Florida-based dermatologist Leslie Baumann, MD. “I believe there is a link between an office visit and compliance when the patient can leave with the recommended medication in hand. Life is full of distractions and making a drug available in the office helps to ensure that the patient will use it in the way it has been prescribed. And, there is an enhanced possibility that use of the drug will begin that day. This means the patient will be able to see results sooner. We dispense several brands in our office, specifically for this reason and I suspect it is a strong trend.”
Another benefit to having a derm-dispensed product in the office is the convenience factor cited by dermatologists. “Dispensing in the office helps ensure patients are getting the formulations and products that we believe are right for them and their skin-care goals,” says Joel L. Cohen, MD, dermatologist and director of AboutSkin Dermatology, in Colorado. “With the more recent addition of Rx product sales in the office, patients find this to be convenient for them, because it helps them avoid a trip, and lines, at the pharmacy and prior authorization delays. Our staff appreciates this as well, with the hope that it will minimize the time spent on prior authorization hassles and help with overall efficiency.”
UCB’s Bimekizumab Performs Well in Phase 3 Psoriasis Study
UCB’s bimekizumab, an IL-17A and IL-17F inhibitor, bested placebo and Stelara (ustekinumab) when it came to clearing the skin of patients with moderate to severe chronic plaque psoriasis and improving their symptoms, the company reports.
BE VIVID is the first of three Phase 3 studies evaluating the efficacy and safety of bimekizumab in the treatment of adults with moderate-to-severe chronic plaque psoriasis. UCB shares rose with the release of the new study data.
After 16 weeks of treatment, bimekizumab met the co-primary endpoints of at least a 90 percent improvement in the Psoriasis Area and Severity Index (PASI 90) and Investigator Global Assessment (IGA) score of clear or almost clear (IGA 0/1).
Among key secondary endpoints, bimekizumab was also found to be superior to ustekinumab in reaching PASI 90 and IGA 0/1 and superior to placebo in total skin clearance (PASI 100 or IGA 0) at Week 16. The initial assessment indicates that the safety profile of bimekizumab was consistent with the earlier BE ABLE Phase 2 studies.
The safety and efficacy of bimekizumab is also being evaluated in psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis.
American Society for Dermatologic Surgery Annual Meeting Updates
New and emerging technologies as well as innovative approaches to existing treatments took the spotlight at the 2019 annual meeting of the American Society for Dermatologic Surgery in Chicago last month.
Presenters addressed aesthetic topics like small volume filler placement. “Focus on certain areas,” says Terrence Keaney, MD. He notes that when using small volumes, “you can optimize filler by placing it in certain locations where you get bigger bang for your buck.”
In a similar vein, Sabrina Fabi, MD explained how she achieves dramatic improvement in the lower face—including indirect lip enhancement—by injecting in the chin. “With just 1cc of filler…in the chin, you can have beautiful aesthetic outcomes,” Dr. Fabi says.
In an interview with Joel L. Cohen, MD, dermatologist Nazanin Saedi, MD talked about maximizing treatments through combinations. For example, she often pairs a pico treatment for pigmentation with ablative or non-ablative lasers to address color and texture in a single session. RF microneedling plus low-energy CO2is another popular option, she says.
Merz Aesthetics brought spokesmodel Christie Brinkley to the exhibit hall, where she addressed changing attitudes about aesthetics. A generation ago, hair coloring was considered taboo, she said with a nod to the old tagline “only her hairdresser knows for sure.” Today, women are open about their aesthetic treatments, she says.
The meeting also highlighted advancements in surgical oncology and medical dermatology. Anthony Rossi, MD spoke on technology disruptors, highlighting the benefits of total body photography and reflectance confocal microscopy. “It’s really an important adjunct not just for the practicing dermatologist but also the dermatologic surgeon.” He uses the technology to map out margins prior to excision of lentigo maligna melanoma.
Watch coverage of the ASDS Annual Meeting, hosted by Joel L. Cohen, MD here.
On the research front, Sebacia presented data showing that its microparticles (silica core covered in gold) coupled with laser support significant improvement in acne. In the ongoing European Union real-world registry, patients were prescribed a two to four-week course of topical retinoid followed by three weekly in-office treatments of Sebacia Microparticles at commercial centers. Clinical results out to two years demonstrate a 92 percent average acne inflammatory lesion count (ILC) improvement at 24 months compared to baseline. More than three-quarters (77 percent) of patients were acne medication-free at 24 months.
A poster presentation from Endo included data from the RELEASE-1 and RELEASE-2 Phase 3 studies, previously presented at the 2019 Aesthetic Society meeting. The identically designed, randomized, double-blinded, placebo-controlled trials assessed the efficacy, safety, and tolerability of collagenase clostridium histolyticum (CCH) for the treatment of cellulite in women. A greater percentage of the 843 women treated during the studies met the primary endpoint of response with CCH versus placebo in both studies. Most adverse events observed in CCH-treated patients were transient, mild/moderate, and injection-site related (e.g., bruising, pain, induration, pruritus, erythema, and discoloration).
Galderma reported positive results of its randomized, controlled, evaluator-blinded, multi-center study to evaluate the effectiveness and safety of HARK for lip augmentation, noting that the data are being used to support FDA submission of the novel injectable.
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