Recent Developments

AAD, Industry Collab to Increase Number of Black, Latino, and Indigenous Physicians in Dermatology

The American Academy of Dermatology (AAD) in collaboration with Johnson & Johnson Consumer Health and the Janssen Pharmaceutical Companies of Johnson & Johnson is launching “Pathways: Inclusivity in Dermatology” to increase the number of practicing dermatologists in the US who are from the Black, Latino, and Indigenous communities, which are underrepresented minorities (URM) in medicine.

The plan is to double representation in the next five years.

Pathways will work to create a more diverse and inclusive specialty by engaging Black, Latino, and Indigenous students from high school age through medical school in programming that builds the skills, knowledge, and interest to pursue a career in dermatology.

Through scholarship offerings, skills workshops, mentorship programs and leadership training, the initiative aims to increase the number of dermatology residents from Black, Latino, and Indigenous communities from approximately 100 residents to 250, or by more than 50 percent, by 2027. Dermatology is one of the more competitive medical specialties, and historically it has not drawn a large number of applicants from URM groups. According to data from the Association of American Medical Colleges, in 2020, just 65 of the 796 applicants for dermatology residencies were Black or African American, and only 39 were Hispanic, Latino, or of Spanish origin.

The Pathways initiative has the potential to substantially reduce barriers to dermatology care given that various studies have linked increased diversity in the physician workforce to improved health care and outcomes for people of color. According to “Increasing racial and ethnic diversity in dermatology: A call to action,” published in Journal of the American Academy of Dermatology, diversity in the physician workforce improves outcomes not only for people of color, but for all patients. Studies reveal that physicians of color are more likely to see non-white patients and provide a disproportionate share of care to underserved populations. This strongly suggests that increasing the number of practicing dermatologists can help reduce health care disparities.

Find more information about the Pathways: Inclusivity in Dermatology program at www.aad.org/pathways.

Janssen Launches VISIBLE Study of PsO in People of Color

The Janssen Pharmaceutical Companies of Johnson & Johnson has initiated VISIBLE, a first-of-its-kind, large-scale prospective clinical study dedicated to people of color living with moderate to severe plaque and/or scalp psoriasis (PsO).

VISIBLE will further evaluate the efficacy and safety of Tremfya (guselkumab) in people of color to generate additional data and provide valuable information about disease burden and the psoriatic disease patient journey in this population. Tremfya has a well-established safety and efficacy profile across a broad patient population of adults with moderate to severe PsO. Noting that over the course of approximately two decades, the majority of Phase 3 PsO clinical trials (across topical, oral, and biologic therapies) have enrolled predominantly white participants (86 percent), Janssen notes a pressing need for more data in people of color. The VISIBLE study is designed to help promote more diverse, equitable and inclusive clinical research in PsO through new approaches to enrollment and retention, broader community engagement and new data components, the company says.

In line with its commitment to expanding inclusive clinical research, Janssen is partnering with community health centers, retail clinics, and local and national organizations to support communities in raising disease awareness and reducing potential obstacles to clinical study enrollment. Because PsO presents differently in people of color, the company is also offering training support for study investigators and taking a unique approach to confirm diagnosis. These efforts aim to help address issues that have led to low screening and recruitment of people of color. The VISIBLE study will also generate a collection of clinical photos across varying skin tones that will help advance patient and health care provider education on how psoriatic disease presents in people of color.

FDA Clears Cutera’s AviClear Acne Device

The FDA has granted 510(k) clearance to Cutera’s AviClear acne device, the first energy device to receive a nod for the treatment of mild, moderate, and severe acne.

AviClear targets acne at the source by selectively targeting the sebocytes and suppressing sebum production. In addition to reducing existing acne, clinical trials show that future breakout episodes are shorter, less intense, and more infrequent following the AviClear procedure (AviClear.com). Further, acne clearance results continue to improve over time, demonstrating the long-term efficacy of this novel treatment. Importantly, no pain mitigation was utilized or required by any clinical study participant.

“AviClear significantly shifts the treatment paradigm for acne by offering a safe, drug-free, and effective alternative to what is currently available,” David Goldberg, MD, JD clinical-trial investigator for AviClear, says. “I am excited about this device because it has an easy user interface and no significant adverse events were observed in the clinical trials, similarly, I know my patients will be thrilled about this new treatment because it can be performed on all skin types, any time of year, and the results are long-lasting.”

“Physicians and patients have long sought a modern alternative to the acne pills, peels and topicals that have been static for nearly 30 years,” adds David Mowry, CEO of Cutera. “Developed with extensive physician and patient input, AviClear was created to redefine the treatment of acne—all without a prescription.”

AviClear is expected to be made available to physicians throughout the United States over the course of 2022.

Galderma Launches Twyneo in the US

Galderma has launched Twyneo (tretinoin and benzoyl peroxide) Cream, 0.1%/3% in the US during the annual meeting of the American Academy of Dermatology (AAD). Twyneo Cream features patented microencapsulation technology that allows the delivery of two ingredients that have not been previously combined and enables their controlled release. It is the first and only 0.1% tretinoin and 3% benzoyl peroxide (BPO) two-in-one combination proven to rapidly treat moderate to severe facial acne.

In clinical trials, some people saw results in as little as two weeks of using Twyneo Cream, and their skin continued to clear over time. These studies demonstrated a 25 percent decrease in pimples at two weeks and a 58–66 percent decrease at 12 weeks. In all, 27–41 percent of people achieved clear or almost clear skin by the end of the trial. More than half of people who used Twyneo Cream were satisfied at two weeks and by 12 weeks of treatment, eight in 10 subjects were satisfied with their results. Twyneo Cream was well tolerated and side effects were mild to moderate and decreased over time. The most common side effects occurring in >2% of persons using Twyneo Cream were application site pain, dryness, erythema (redness), and exfoliation.

Twyneo Cream will be available throughout the US by prescription in Q2. A month’s supply of Twyneo Cream costs $0 for commercially covered patients or $60 for uninsured patients with the Galderma CAREConnect savings card. Twyneo Cream may cost less than generic tretinoin alone when using the Galderma CAREConnect savings card.

Mark D. Kaufmann, MD, FAAD Takes the Helm at AAD

Long-time Practical Dermatology® Digital Practice editor Mark D. Kaufmann, MD, FAAD, is the new President of the American Academy of Dermatology.

Dr. Kaufmann, a clinical professor of the Department of Dermatology Icahn School of Medicine at Mount Sinai in New York, began his one-year term immediately following the Academy’s annual; meeting, which was held in Boston from March 25–29.

He previously served the Academy as a member of its Board of Directors, as deputy chair of the AADA’s Patient Access and Payer Relations Committee, and as a past member of the AADA’s Council on Government Affairs and Health Policy.

In addition, two new officers and four new board members will be installed to help lead the AAD.

Linda F. Stein Gold, MD, FAAD, will hold the office of vice president. She is the director of dermatology clinical research at Henry Ford Health in Detroit and division head of dermatology at Henry Ford in West Bloomfield, Michigan. She previously served the Academy as a member of its Board of Directors and Executive Committee. In addition, Dr. Stein Gold has served on the medical board for the National Psoriasis Foundation and the American Acne and Rosacea Society.

Daniel D. Bennett, MD, FAAD, will hold the office of secretary treasurer for three years. Dr. Bennett is Vice Chair of Clinical Affairs for the Department of Dermatology at the University of Wisconsin-Madison. He has served in numerous roles at the Academy, including as chair of the AADA’s Mohs Micrographic Surgery Committee. Dr. Bennett also previously served on the Wisconsin Medical Society’s Board of Directors.

Keyvan Nouri, MD, MBA, FAAD, will hold the office of assistant secretary-treasurer for three years. Dr. Nouri is Louis C. Skinner, Jr., MD Endowed Chair of Dermatology, Richard Helfman Professor of Dermatologic Surgery, chair of the University of Miami Medical Group, and director of Mohs, dermatologic, and laser surgery and director of surgical training for the University of Miami department of dermatology. Dr. Nouri previously served on the AAD’s Education and Volunteers Abroad Committee and World Congress Fund Review Task Force.

Tammie Ferringer, MD, FAAD; Brad P. Glick, DO, MPH, FAAD; Adrian O. Rodriguez, MD, FAAD; and Ruth Ann Vleugels, MD, MPH, MBA, FAAD, were elected to the Academy’s Board of Directors. They will each serve a four-year term beginning in March 2022.

These officers and board members will also hold the same position for the American Academy of Dermatology Association.

CLOSE UP with Brett King, MD, PhD

Alopecia is getting lots of attention in the press after the Chris Rock-Will Smith kerfuffle at the Academy Awards. Mr. Smith jumped on stage and slapped Mr. Rock for making a joke about his wife’s hair loss. Mr. Smith’s wife, Jada Pinkett Smith, has alopecia, which can have devastating effects on self-esteem, and there are no approved treatments. This is why Brett King, MD, PhD, associate professor of dermatology at Yale School of Medicine in New Haven, CT, is so excited about the results of the BRAVE studies looking at baricitinib for the treatment of alopecia areata. Dr. King talked to Practical Dermatology® about these exciting findings.

Why is this topic important to study?

Brett King, MD, PhD: Alopecia areata is an autoimmune disorder that causes hair loss that is often disfiguring. The scalp, eyebrows, eyelashes, beard in males, and body hair can be involved. Baldness, bald spots, or missing eyebrows or eyelashes that can onset in the early to mid-20s, can take an emotional toll on patients. There are no federal Food and Drug Administration (FDA)-approved treatments.

Describe the research and your findings.

Dr. King: In two double-blind, placebo-controlled Phase 3 trials dubbed BRAVE-AA1 and BRAVE-AA2, 1,200 patients with severe alopecia areata were randomized to receive once-daily Olumiant 4mg, Olumiant 2mg, or placebo. Patients randomized to Olumiant received the same treatment for 52 weeks while placebo non-responders were rescued to Olumiant at 36 weeks. The primary endpoint was SALT score ≤20 (≤20% scalp hair loss). Secondary endpoints included the proportion of patients who achieved a SALT score ≤10 (≤10% scalp hair loss), Clinician-Reported Outcome (ClinRO) Measure for Eyebrow Hair Loss, and ClinRO Measure for Eyelash Hair Loss scores of patients achieving eyebrow and eyelash hair loss scores of 0 or 1 (full coverage or minimal gaps) with a ≥2-point improvement from baseline among patients with baselines scores ≥2. In the BRAVE studies, 51.7 percent of patients were white (n=620/1,200), 36.3 percent were Asian (n=435/1,200), 8.2 percent were Black (n=98/1,200). The clinical trial published in the New England Journal of Medicine shows the week 36 results of Eli Lilly’s trial of baricitinib, a medicine already approved for treatment of rheumatoid arthritis, another autoimmune disease. The full 52-week data was presented at the annual meeting of the American Academy of Dermatology. It showed nearly 40 percent of adults on Olumiant 4mg, all of whom started out with at least 50 percent scalp hair loss, experienced full or nearly full scalp hair coverage, and similar improvements were achieved for patients with significant gaps or no notable eyebrows or eyelashes at 52 weeks.

What is the next step?

Dr. King: Baricitinib, a potential first-in-disease medication, is under priority review with the FDA with a decision expected this year based on this pivotal data.

Update: Skin Reactions to COVID-19 and Its Vaccines

Thanks to a comprehensive COVID-19 dermatology registry, dermatologists now have gathered a great deal of data on skin reactions caused by COVID-19 and its vaccines.

“Early April of 2020, the American Academy of Dermatology and the International League of Dermatologic Societies put together a COVID-19 dermatology registry, which allows dermatologists to better understand the skin reactions that people experience from the COVID-19 virus,” says board-certified dermatologist Esther Ellen Freeman MD, PhD, FAAD, director, global health dermatology, Massachusetts General Hospital, Harvard Medical School, in a news release. “Through this registry, physicians and health care professionals across the world share information about the cases they’re seeing, which assists us in recognizing the common skin reactions caused by COVID-19 and helps us better diagnose and treat our own patients.”

Dr. Freeman notes that dermatologists have found a variety of different skin reactions that are associated with COVID-19. Some reactions are milder, like COVID toes, and others are more severe. People have a large variability in their immune response to the COVID-19 virus, which causes the skin to react differently for each person.

“Data from large studies in Europe show us that about 10 percent of patients with COVID-19 will have a skin reaction. Of the patients who do have a rash, about 20 percent will develop the rash either as their only sign and symptom of COVID-19 or their first sign and symptom of COVID-19,” says Dr. Freeman. “In fact, you’re more likely to develop a skin reaction from COVID-19 itself than you are to develop a serious skin reaction from the COVID vaccine.”

The duration and treatment of the skin reaction depends on the type of reaction the person has; however, Dr. Freeman says most reactions usually resolve within a month. There are patients who have had skin reactions, such as COVID toes or hives, which have lasted six-to-12 months after the infection, but those types of cases tend to be uncommon.

Dr. Freeman notes that while different variants of COVID-19 are associated with different symptoms, it’s too early to tell if the different variants cause different skin reactions.

“The symptoms COVID patients experience with the Omicron variant are different from the symptoms COVID patients experience with the Delta variant. For example, the loss of taste and smell, which is very common in patients with Delta, appears to be less common in patients with Omicron. Similarly, a sore throat, which was not common with Delta, is now actually being noted much more commonly in Omicron,” says Dr. Freeman. “I do expect that we may see some differences in how people’s skin reacts to different variants in the coming months, but we just don’t have enough data yet to know.”

In addition to skin reactions being caused by COVID-19, some people report having reactions from the COVID-19 vaccine. Similarly, to what dermatologists are seeing in how the immune system responds to the virus after having COVID-19, they’re also seeing that people’s immune systems respond differently to the vaccine, which means there’s a spectrum of different skin reactions that can be caused by the vaccine.

One of the most common reactions that people can experience is a delayed local reaction to the vaccine, also known as “COVID arm.” The reaction typically starts about a week after the injection, and involves a discolored, raised area over the injection site which goes away on its own, is not harmful and should not stop people from getting vaccinated again.

According to Dr. Freeman, less than 50 percent of the people who experience a reaction to their first dose have the same reaction to the second dose. It is rare for people who did not have reactions to the vaccine to develop a reaction to the booster.

“After 10 billion doses of the vaccine given worldwide, there’s a lot of safety data,” says Dr. Freeman. “Vaccines are safe and effective, and we encourage the public to consider getting their vaccines and booster to protect themselves against COVID-19.”

Mount Sinai Health System Launches Alopecia Areata Center of Excellence

In an effort to deliver outstanding comprehensive care and to employ revolutionary approaches to novel therapeutics around the skin condition alopecia areata, the Mount Sinai Health System has launched the Alopecia Areata Center of Excellence. Under the leadership of Director Emma Guttman-Yassky, MD, PhD, the new Center will be fully integrated within the state-of-the art Laboratory for Inflammatory Skin Diseases, and will fall under the umbrella of the Kimberly and Eric J. Waldman Department of Dermatology at Mount Sinai.

The creation of this new Alopecia Areata Center of Excellence was made possible by a generous $5 million gift from the Pure Family. More than 7 million people in the United States have alopecia areata, an autoimmune disease that causes hair to fall out from the scalp, face, and other parts of the body.

“I am honored by the Pure Family’s tremendous support for this new Center, which will help immensely to position Mount Sinai Dermatology as a true leader in alopecia areata,” says Dr. Guttman-Yassky, who is the Waldman Professor and Chair of the Kimberly and Eric J. Waldman Department of Dermatology, Icahn School of Medicine at Mount Sinai. “We are now uniquely positioned to make an extraordinary difference in the lives of millions of adults and children who have this terrible, life-altering condition.”

Take 5 with Paula Brown Stafford, MPH, President and CEO, Novan

With the stroke of a pen last month, when EPI Health became a Novan company, a long-watched precommercial company grew into a leading commercial entity in dermatology. Paula Brown Stafford, CEO of Novan and now EPI Health, spoke with Practical Dermatology® magazine about the acquisition.

Novan is focused on Innovation.

“At Novan, our vision has been to be a specialty dermatology company focused on developing and marketing innovative, therapeutic products for skin diseases. From a cultural standpoint within Novan—and taking this forward now into the broader company—innovation is one of our five values. The way we are trying to go from development to marketing innovative therapeutic products for skin diseases probably says that best.

The other pillars are P for performance, R for respectful, I for innovative, D for dynamic, and E for engaged.

Of course, EPI Health had its own values and has also been focused on innovation. There is overlap in the spirit of those values if not the specific naming of them between the two companies, and we’re going to be going through a process to combine those values.

The culture of innovation that we both have will definitely remain prominent.”

Novan + EPI = “Force Multiplier”

“We believe that Novan plus EPI Health together that really is a force multiplier. We are a leading company in this space now, because we can take a product from the bench all the way to the bedside.

As Novan Inc. we were an R&D company. With the acquisition of EPI Health, we are able to create that full platform, that infrastructure from discovery to commercialization. It enables a strong launch platform for Novan’s lead product candidate, which is SB206 or berdazamir gel, 10.3%.”

The Non-traditional Model Works

“Insofar as Novan as a pre-commercial R&D company acquired an established commercial operation in EPI, ours is a different model. I think the industry needed something new.

Novan was looking at the right way to launch SB206 and looking at more traditional models and non-traditional ones. We looked at multiple options for commercializing SB206, if it’s approved. We found this to be the best path for us.

It’s a little different route than others have taken, but we wouldn’t have done it if we didn’t think we’d be successful.”

EPI Health, A Novan Company Will Focus on Medical Dermatology

“Our strategic focus is on medical dermatology. It’s not on aesthetics. It’s not on OTC. We are bench to bedside with prescription medications.

We don’t see—in our three- to five-year strategy—that we need to enter those areas to be successful, because of the pipeline that we have. And we see potential to meet unmet need.

We have a very promising pipeline of near- and later-term asset opportunities. If you look out through the next three, five, 10 years, we have the opportunity to continue to bring new, innovative dermatology products, potentially to market.

First, our lead clinical development product candidate is for molluscum contagiosum. It is an area of unmet need because today there is no FDA-approved prescription medicine.

And then the next development program behind that is for acne vulgaris. And then behind that, we have opportunities in atopic dermatitis, possibly psoriasis. We have tinea pedis and onychomycosis, as well as external genital warts.

And we’ll continue to partner with the dermatology community. I attended the AAD Annual Meeting, and we had a large team attending, because we want to support educational initiatives for HCPs and the patients that we serve.”

Dermatologists Can Count on Continuity

“The Dermatology community should not expect to see much change, just a continuation of some of the same practices that have been coming from the EPI Health organization. They will have all the same interfaces. The existing sales force and the contacts that they have will remain in place. We actually plan to grow the sales force in 2022 to cover up to eight more territories.

We will continue to invest in patient co-pay assistance and samples in their offices. We will continue to apply further efforts with payers to increase coverage for the existing portfolio, as well as potential future treatments.”

Aquavit Submits NDA for New Neurotoxin

Aquavit Pharmaceuticals, Inc. has submitted its IND for a new botulinum toxin (DTX-021) to the FDA for approval.

DTX-021, a botulinum toxin type A drug intended for the treatment of moderate to severe glabellar lines, is a highly purified and clinically tested injectable neuromodulator with a 900kDa protein complex derived from neurotoxins produced by Clostridium botulinum.

Aquavit says it will be initiating a long-term Phase-II clinical trial shortly after approval of the IND. With FDA approval, DTX-021 (to be marketed as Dermatox) will enter the fast growing US $5.3 billion dollar market with a CAGR of 7.8%, reaching US $9 billion dollars by 2026.

Aquavit is accelerating its clinical development program by introducing DTX-022 shortly after DTX-021. With final approval of DTX-022, it will be the world’s first FDA approved pan-facial microinjection of neurotoxins. DTX-022 features a novel route of administration (RoA) of DTX-021 utilizing Aquavit’s innovative microchannel delivery system, a patented “repeated motion” technology.

Aquavit is currently evaluating other potential therapeutic indications of botulinum toxins.