Recent Developments

Revance Acquires Exclusive US Distribution Rights to Teoxane SA Fillers

Revance Therapeutics, Inc. is the exclusive commercialization partner of Teoxane SA in the US. With a new distribution agreement announced last month, Revance gains immediate and exclusive rights to commercialize Teoxane’s Resilient Hyaluronic Acid (RHA) line of fillers in the US, starting with the FDA-approved RHA 2, RHA 3, and RHA 4 products, which include lidocaine.

Revance says it believes the RHA dermal filler line, in combination with the company’s next-generation neuromodulator, DaxibotulinumtoxinA for Injection (DAXI), will position the company to be the innovation leader in the $2 billion US facial injectable market.

The RHA line provides physicians with a broad range of uniquely designed gels for individualized treatment in the face. The RHA line was designed using a patented crosslinking method that preserves the hyaluronic acid network for correction of moderate to severe dynamic facial wrinkles and folds. The formulation optimizes strength, stretch, and tissue integration. Filler injections with RHA gels have been shown to be safe and well tolerated.

The agreement also includes a fourth product, RHA 1, currently in clinical trials in the US with FDA approval anticipated in 2021, and includes an ongoing collaboration with Teoxane SA for a robust pipeline of additional indications and next-generation dermal filler technologies. Additionally, the agreement contains a right of first negotiation to access Teoxane’s novel cosmeceutical line that incorporates its propriety RHA technology.

In consideration for the US distribution rights for all of the above mentioned, Revance has agreed to issue 2.5 million shares of Revance common stock to Teoxane SA.

Revance has begun the build-out of a US commercial organization and is targeting the introduction of the Teoxane RHA fillers in the second quarter of 2020, followed by the launch of DaxibotulinumtoxinA, upon anticipated regulatory approval, in the second half of this year.

Patients Report 95 Percent Satisfaction Rate with Mohs Surgery for Melanoma

Patients who received Mohs surgery to treat melanoma reported a 95 percent long-term satisfaction rate with their results, according to a new study by UT Southwestern Medical Center dermatologists.

The study, published in Dermatologic Surgery, is the first to poll patient satisfaction for Mohs surgery. The findings complement previous scientific studies that found Mohs surgery is as effective as wide local excision for early melanomas, says study author Divya Srivastava, MD, a UT Southwestern board-certified dermatologist and fellowship-trained Mohs surgeon.

“Patient satisfaction is becoming such an important part of medicine these days, so we wanted to look to see what we can do to get patients more satisfied with the care that they are getting for their skin cancer treatment. That’s a big area of interest for a lot of the subspecialties,” she says.

UT Southwestern researchers surveyed 42 of its patients who underwent this technique. The majority of patients were white men with a mean age of 69. Three-quarters of the tumors were located on the face. The remaining were on the scalp, extremities, and neck.

This small survey suggests patients are discovering that the long-term benefits of excision with 100 percent margin control using Mohs surgery greatly outweigh any potential perceived inconvenience. At UT Southwestern, dermatologic surgeons also provide immediate local tissue reconstruction, using advanced reconstruction techniques to diminish the appearance of scars.

The study was funded by a $5,300 grant from the Cutting Edge Research Grant Program of the American Society for Dermatologic Surgery.

Alma Introduces Opus Plasma

Alma, Inc. is launching Opus in North America. Opus is a new platform featuring the company’s proprietary high-frequency unipolar radio-frequency technology, Opus Plasma.

Opus Plasma is the first fractional plasma technology to enter the fractional resurfacing category, the company states. “Fractional plasma will change how we think about resurfacing. If full-field CO₂ technology was resurfacing 1.0, and fractional technology was resurfacing 2.0, fractional plasma technology is resurfacing 3.0,” says Jeffrey Hsu, MD, FAAD, a dermatologist at Oak Dermatology in the Greater Chicago Area, in a news release. “I can produce results to match the most aggressive CO₂ laser or the gentlest laser peel in a fraction of the procedure time and much less patient downtime. The results we’re seeing with Opus Plasma are quite impressive, even after just one treatment.”

Operating at a high frequency of over 40MHz, the metal pins on the Opus Plasma tips are super-charged with high-RF voltage. When in close proximity of the skin, the RF-charged pins react to atmospheric pressure in the air, creating plasma that in turn, creates the microthermal zones of fractional injuries. The plasma intensity can be adjusted based on the desired ablation effect, which further expands the versatility of the technology—a light, moderate, or aggressive resurfacing result can be achieved based on the desired outcome and patient skin type.

Attendees at the 2020 American Academy of Dermatology conference can check out Opus with Opus Plasma at Alma’s Booth #3717.

SU2C Calls for Increased Diversity in Cancer Trials

Stand Up to Cancer (SU2C) announced a new diversity initiative that aims to make sure current advances in diagnosing and treating cancers don’t leave anyone out.

The lack of diverse participation in cancer clinical trials may be due to socio-economic, cultural, trust, and other barriers. Artificial or augmented intelligence combined with machine learning is largely seen as the way forward when it comes to making less invasive and speedier skin cancer diagnoses, but this could lead to mis- or under-diagnoses among certain skin of color patients if the samples are not diverse, explains John Whyte, MD member of SU2C’s Health Equity Committee and the Chief Medical Officer of WebMD, during a news conference hosted by journalist Katie Couric.

Most of the data and images included in current algorithms are from Caucasian populations, he says. “We are trying to [harness] technology to diagnose skin cancer when the population [included in current algorthims] is primarily white,” he says. “It is a concern that you will misdiagnose skin cancer in people of color [based on today’s algorithms].”

Established in 2008, SU2C raises funds for cancer research. As part of the new diversity initiative, the group will now mandate that future SU2C-supported research grant proposals include and address crucial issues related to recruitment and retention of patients from ethnic groups to improve diverse participation in cancer clinical trials.

Maternal Depression Linked to AD in Kids

Maternal depression in the postpartum period, and even beyond, is associated with the development of atopic dermatitis (AD) throughout childhood and adolescence, according to a recent study published in the journal Dermatitis.

The study, led by Jonathan Silverberg, MD, PhD, MPH, associate professor of dermatology at the George Washington University School of Medicine and Health Sciences in Washington, DC, examined the association of maternal depression in the postpartum period, and maternal and paternal depression in later childhood with AD in US children and adolescents.

The researchers analyzed data from the Fragile Families and Child Wellbeing Study. They found that postpartum depression was associated with higher odds of AD developing later in childhood, more persistent AD, and increased sleep disturbance among children with AD.

“Our results further suggest that postpartum depression is associated with AD even in older children and adolescents, with more persistent disease and greater sleep disturbance,” Silverberg said. “This could potentially suggest more severe AD.”

Continued research is needed, according to the researchers, to confirm the associations found, determine underlying mechanisms, and identify appropriate interventions. The authors of the study suggest that pediatricians should consider screening and early intervention for postpartum depression to identify infants at higher risk for AD. Children born to mothers with depression in the postpartum period and beyond may warrant increased screening for AD and atopic disease, as well as use of gentle skin care and other strategies to mitigate AD.

Crown Restructures after Acquisitions

Crown Laboratories has restructured its commercial operations business units as it continues its efforts to elevate its new “Skin Science for Life” commitment.

For the past two years, Crown says it has been dedicated to transforming its Northeast Tennessee operations into a global skincare company. After acquiring its Beauty and Aesthetic divisions, (formerly Vita Liberata and Bellus Medical, respectively), and strengthening its therapeutics portfolio through the acquisition of six consumer heritage brands from GlaxoSmithKline, Crown is now poised to become a leader in dermatology health and wellness.The rebranding of Crown Aesthetics officially launched on January 30 in Paris at the IMCAS World Congress 2020. Crown now comprises:

• Crown Aesthetics: Formerly Bellus Medical, which offers SkinPen, Skinfuse, ProGen PRP, and Allumera. Crown Aesthetics launched ProGen PRP Advantage, an easy-to-use, single-spin system that features 15ml and 30ml tubes, yielding 7-15ml of 2x concentration PRP. With the launch of ProGen PRP Advantage, physicians will now be able to deliver platelet rich plasma (PRP) procedures more efficiently and conveniently.
• Crown Beauty: Formerly Vita Liberata Limited, makers of Vita Liberata and NKD SKN sunless tanning beauty products.
• Crown Therapeutics: A new unit comprising Blue Lizard Australian Sunscreen, PanOxyl, Sarna, and several other therapeutic brands.

“The improved structure and naming convention of these business units allows for a more memorable, distinct alignment within our organization,” says Jeff Bedard, President and CEO of Crown. “We believe the power of team is far greater than the power of one, and by incorporating Crown into each of our business unit names, we are ensuring our customers recognize the greater team that stands with them. Whether patients require a therapeutic solution, are seeking an aesthetic treatment or beauty need, Crown is here to fulfill those needs.”

CLOSE UP with Kyla Price, BS and Vivian Y. Shi, MD

Hidradenitis suppurativa (HS) affects between one to four percent of people in the US, according to the Cleveland Clinic. HS may be marked by mild itching, discomfort and appearance of red, tender, and swollen areas. Sometimes boils will form, fill with pus, and then break open. This condition can have negative effects on self-esteem and quality of life. There is no cure for HS and in many cases, conventional therapy isn’t wholly effective. Researchers recently looked at the potential role of complementary and alternative medicine (CAM) including dietary changes, supplements and exercise, in improving outcomes among HS patients. The findings appear in the January 29, 2020 issue of JAMA Dermatology. Here, lead author Kyla Price, BS, a dermatology research fellow at University of Arizona, Tucson and Vivian Y. Shi, MD, Assistant Professor and the Director of the Inflammatory Skin Research Program, Eczema Specialty Clinic and Hidradenitis Suppurativa Specialty Clinic in the Department of Medicine, Dermatology Division of University of Arizona, Tucson, explain the significance of their findings and discuss next steps.

PD: WHY IS THIS TOPIC IMPORTANT TO STUDY?

Ms. Price and Dr. Shi: HS presents as a very burdening and often painful disease for those affected by it. When compared to other dermatologic diseases, HS frequently demonstrates more negative impact on quality of life. Many patients also do not achieve adequate disease coverage with conventional therapies. As we strive to mitigate some of the burden of this disease, understanding the potential benefits of different methods of CAM can be impactful in improving patient outcomes.

PD: DESCRIBE THE RESEARCH AND YOUR FINDINGS.

Ms. Price and Dr. Shi: We conducted an anonymous survey that was distributed at HS specialty clinics located at the University of Arizona in Tucson, University of California Los Angeles, and at the York Dermatology Clinic in Ontario, Canada. The survey was also distributed online though the HS social media groups, Hope for HS, International Association of HS Network, and HS Warriors. The main goal was to examine how HS patients currently use CAM and whether the methods they have tried have been successful. Overall, 84.2 percent of respondents reported CAM use. The most common reasons for starting CAM was frustration with conventional therapies or a desire to try something “new” or more “natural” treatments. The most commonly used CAM products were turmeric/curcumin, magnesium sulfated bath, and zinc. Patients had the most success with marijuana, magnesium sulfate bath, and topical cannabidiol (CBD) oil. The most commonly implemented lifestyle practices for HS included dietary changes, tobacco cessation, and yoga or Pilates. Among the different lifestyle practices, dietary changes were the most beneficial. Of those that used CAM, 65.1 percent found it at least mildly successful, while nearly half of respondents found conventional therapy not very successful.

PD: WHAT IS THE NEXT STEP?

Ms. Price and Dr. Shi: The prevalence and reported benefit of CAM use in HS patients suggests a further need to examine the efficacy, safety, and mechanisms of CAM therapies. Examining CAM methods can also allow clinicians to be more familiar with their potential benefits while also allowing for understanding of their potential interactions with conventional therapies. The therapeutic landscape for HS is rapidly expanding with numerous targeted immunomodulators in the pipeline, thus strategic implementation of CAM alongside conventional HS therapies can valuable in improving patient outcomes.

Dr. Susan Weinkle Honored with Outstanding Educator & Mentor in Dermatology Award at ODAC

Susan H. Weinkle, MD, was awarded the Outstanding Educator & Mentor in Dermatology Award by the ODAC Dermatology, Aesthetic & Surgical Conference, in partnership with the Journal of Drugs in Dermatology (JDD), at the conference held January 17-20 in Orlando, FL.

Photo credit: Courtesy of James Dick, Event Photographer

The award recognizes individuals who have demonstrated a long-standing commitment to educating and mentoring the next generation of dermatologists, and who have devoted a major portion of his or her professional life to enhancing the practice and profession of dermatology through education.

“Physicians around the globe have learned so much from Dr. Susan Weinkle,” says dermatologist and ODAC vice conference chair Joel L. Cohen, MD.

Dr. Weinkle is an assistant clinical professor of dermatology at the University of South Florida, Tampa, FL. She is a past president of the Women’s Dermatological Society and the American Society for Dermatologic Surgery. In addition, Dr. Weinkle is a former committee chair and member of the board of directors of several dermatology organizations, including the American Academy of Dermatology, Dermatology Foundation, and Florida Society of Dermatology and Dermatologic Surgery. Dr. Weinkle is in private practice in Bradenton, FL, specializing in Mohs Micrographic Surgery and cosmetic dermatology. Her daughter, Allison, will join the practice upon completion of her dermatology residency and fellowship in cosmetic dermatology and Mohs Micrographic Surgery.

Revian Shares Data on Revian Red

Revian Inc. has received from the United States Patent and Trademark Office (USPTO) U.S. Patent No. 10,265,258—the seminal patent on the use of proprietary color combinations of light to regenerate living tissue in the body.

The claims in this issued patent cover the use of specific wavelengths of LED light to stimulate the body’s cellular generation of nitric oxide as well as to release the body’s natural nitric oxide reserves. Nitric oxide has a remarkably diverse range of biological functions as it is involved in the proper function of virtually every organ in the human body, and its decline is linked to many degenerative diseases of aging.

Revian Red is the first product to employ the therapeutic advances enabled by combining LED technology and nitricoxide medical research. This advanced medical device is clinically proven to stop hair loss and grow new hair, providing a potentially life-changing treatment for men and women suffering from androgenetic alopecia.

Revian also shared final data from a randomized, double-blind study of the Revian Red hair growth system demonstrated the ability of the system to successfully stop hair loss and subsequently grow new hair. Findings were presented at the 2020 Winter Clinical Dermatology Conference–Hawaii and are now available on the Revian website.

Adult men and women diagnosed with androgenetic alopecia were randomly assigned to use of the Revian Red dual wavelength, all-LED hair growth cap or placebo cap (with no light therapy) for 10 minutes per day. Among participants who were at least 80 percent compliant with the treatment protocol, use of the Revian Red system was associated with a mean improvement of 26.3 hairs/cm² over the placebo cap. Preliminary results had shown that participants assigned Revian Red had an average of 21.3 more hairs/cm².

As part of the study, a quality-of-life questionnaire was used to assess itching, burning and stinging, irritation, and other patient-reported outcomes. Participants scored each question on a scale from 1 (never) to 5 (all the time). Statistically significant reductions were observed in patient-reported pruritus (itch) and burning/stinging compared to sham after 16 weeks of once-daily, at-home treatment.

The mechanisms of action for improved scalp symptoms are proposed to be the anti-inflammatory effects of nitric oxide (NO) released with the patented dual wavelength light. Revian, Inc. is unaware of any previous reports of a reduction in “itchy scalp” with traditional single-color laser-based devices used to treat androgenetic alopecia.

The dual wavelength, all-LED Revian Red device demonstrated excellent safety. During the trial, there were no treatment discontinuations due to an adverse event and there were no device-related serious adverse events reported for any treatment arm.

Almirall on the Move with Three New Collabs

With three new strategic agreements, Almirall, S.A. is set to strengthen their early-stage research portfolio and expand their pipeline in medical dermatology.

Alimirall and 23andMe have signed an agreement allowing Almirall to in-license 23andMe’s bispecific monoclonal antibody designed to block all three members of the IL-36 cytokine subfamily. This family is associated with multiple inflammatory diseases, including various dermatological conditions.

In addition, Almirall and WuXi Biologics signed a strategic collaboration agreement for multiple bispecific antibodies targeting dermatology diseases including atopic dermatitis. Under the terms of the agreement, Almirall has access to WuXi Biologics’ proprietary antibody platforms including WuXiBody to discover multiple novel bispecific antibodies. This strategic collaboration permits Almirall to develop the medication under license and maintain ownership for medical use of the resulting components.

Almirall also entered into an option agreement to acquire Bioniz Therapeutics, Inc. for full global rights to BNZ-1, a multicytokine inhibitor that selectively blocks the activity of three cytokines of the same family: IL-2, IL-9 and IL1-15, currently in phase 1/2 development for refractory Cutaneous T-cell Lymphoma. If Almirall exercises the option, it will also enter into a broader research agreement with Bioniz NewCo, using its multiple cytokine inhibitor platform with the objective to deliver at least 3 IND-approved candidates.

BNZ-1 is also being developed for the treatment of alopecia areata. BNZ-01 has been evaluated in Ph1 Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) and is currently being evaluated in a Phase 1/2a study in CTCL patients and ready to start a Phase 2 PoC study in Alopecia Areata.

Mattel Releases New Barbie Dolls with Vitiligo, Alopecia

In an effort to be more inclusive, Mattel, the maker of Barbie dolls, has released new dolls in its Fashionista line including a Barbie with alopecia and one with vitiligo.

“For 2020, Barbie is continuing the journey to represent global diversity and inclusivity in the fashion doll aisle by showcasing a multi-dimensional view of beauty and fashion by adding: a doll with skin condition vitiligo, a doll with no hair, a doll with a darker skin tone that uses a gold prosthetic limb, Ken with long rooted hair (all for the first time),” according to a company statement.

Ortho Dermatologics Opens 2020 Aspire Higher Scholarship Program

Bausch Health Companies Inc. and its dermatology business Ortho Dermatologics opened the application process for its 2020 Aspire Higher scholarship program. The program, which began in 2012, will award nine students who have been treated for a dermatologic condition with a $10,000 scholarship in support of their academic goals.

To apply for the 2020 scholarship, students are required to submit letters of recommendation along with a long-form essay describing the impact of their dermatologic condition and the role that a dermatologist, physician assistan,t or nurse practitioner played in helping to treat their condition. Scholarships are open to applicants who have been accepted to or students currently attending an accredited, nonprofit, two- or four-year college, university, or advanced (post-high school) vocational or technical school for the 2020-2021 academic year.

Students can apply for the Aspire Higher scholarship through April 27, 2020, and winners will be announced on July 15, 2020. To learn more about the scholarship, including eligibility criteria, terms and conditions, and to see stories from previous winners, visit www.AspireHigherScholarships.com.