Recent Developments

GW Dermatology, La Roche-Posay Establish GW Skin Cancer Research Acceleration Fund

The Department of Dermatology at the George Washington University (GW) School of Medicine and Health Sciences (SMHS) has partnered with La Roche-Posay to establish the La Roche-Posay Skin Cancer Research Acceleration Fund at GW.

The $50,000 gift will be used to support the growth of the GW Cutaneous Oncology Program, led by Vishal Patel, MD, assistant professor of dermatology at GW SMHS and director of cutaneous oncology at the GW Cancer Center.

“We are grateful for the continued and evolving partnership with La Roche-Posay. Their investment in research and education at GW SMHS, now focusing on skin cancer, will have positive ripple effects throughout our specialty,” says Adam Friedman, MD, professor and chair of the GW SMHS Department of Dermatology and director of the Supportive Oncodermatology Clinic, which has also received support from La Roche-Posay.

This new award will fund Dr. Patel’s work aimed at accurate identification of skin cancer, risk stratification of tumor aggression, and preventative therapies to keep tumors from forming in the first place. He is currently investigating the use of artificial intelligence to help dermatologists more accurately identify skin cancers as well as predict their behavior and multifaceted, chemopreventive approaches to prevent the growth of non-melanoma skin cancers, such as squamous and basal cell carcinoma.

“I am confident we can make significant strides in how we approach and manage skin cancer,” Dr. Patel says. “We need to prioritize novel approaches that improve our diagnostic abilities and therapeutic options so we can provide personalized, cutting-edge, and cost-effective care to our patients. I am thrilled to have this support from La Roche-Posay. This gift will not only help us spur innovation, but it will also help impact our patients’ lives and the field of dermatology as a whole.”

Juvéderm Volbella XC Scores FDA Nod for Undereye Hollows

The FDA has approved Allergan Aesthetics’ Juvéderm Volbella XC for improvement of infraorbital hollows in adults over the age of 21.

Per FDA requirement for this new indication, Allergan Aesthetics is providing a product training program for all interested providers, which includes facial anatomy and considerations for safe injection in this area, as well as identification and management of potential complications. Successful completion of this training is necessary prior to administration of Juvéderm Volbella XC for this new indication.

During the required infraorbital hollows training through the Allergan Medical Institute (AMI), providers will be educated on how to assess facial anatomy holistically where Juvéderm Volbella XC may be added as part of a treatment plan to address volume loss in the midface. The required training can be accessed and completed at VolbellaTraining.com.

According to the clinical studies, the primary effectiveness criteria were met in the treatment group’s responder rate of 83.1 percent and was statistically significantly greater (p<0.0001) than the responder rate for the no–treatment control group (15.6 percent) based on the mITT population with multiple imputation. The mean improvement was clinically significant (≥ 1 point), with the majority of subjects demonstrating improvement through one year. In addition, 90.1 percent of patients were willing to recommend the treatment to a friend.

The majority of subjects in the clinical study experienced a side effect, such as tenderness to touch, bruising, swelling, lumps/bumps, redness, pain after injection, firmness, discoloration (not redness or swelling), or itching as reported in their 30-day daily diaries. A majority of these side effects were mild (easily tolerated) in severity, although a few subjects experienced mild swelling more than 30 days after treatment. The swelling was treated with antibiotics for one subject; the other subjects did not require treatment. All of these events resolved within 45 days.

Juvederm Volbella XC was first FDA–approved in 2016 for use in the lips and perioral rhytids.

Study: Oral Dutasteride Outperforms Other Male Hair Loss Treatments

The top-ranking hair loss treatment for men is dutasteride (Avodart) capsules, at a dose of 0.5 milligrams a day, according to a new meta-analysis of 23 studies published online in JAMA Dermatology.

When researchers compared various dosages of the three oral and topical medications—minoxidil, dutasteride, and finasteride, they found that dutasteride produced the biggest increase in total hair count after six months of use. Next up was finasteride (Propecia) pills, taken at a 5-mg dose each day, followed by the same dose of oral minoxidil (Rogaine), the study showed.

A lower dose of finasteride (1 mg a day) ranked fourth, followed by two topical formulations of minoxidil, with the higher dose (5%) performing better than the lower (2%), and low-dose oral minoxidil, taken as 0.25 mg per day, ranking at the bottom.

“The findings of this meta-analysis contribute to the comparative effectiveness literature for androgenetic alopecia therapies with regard to the compared interventions,” the study authors conclude.

Fat Cells in the Skin May Help Fight Acne

New research published in Science Translational Medicine suggests that fibroblasts outside of hair follicles play a larger role in acne development.

Fibroblasts produce an antimicrobial peptide called cathelicidin in skin. To counter an infection within a hair follicle, the surrounding skin undergoes a process called reactive adipogenesis in which fibroblasts transform into fat cells. Cathelicidin is produced to help combat the infection by suppressing bacteria that can cause acne.

The research team performed skin biopsies on acne patients treated for several months with retinoids, a class of chemicals derived from vitamin A found to promote skin health. To the researchers’ surprise, the drug enhanced cathelicidin expression after treatment, thus finding an additional, unknown mechanism for why retinoids help treat acne.

To support these findings, researchers studied skin lesions on mice injected with the acne-causing bacteria and observed similar treatment responses in the mice.

“These findings may transform the way we treat acne,” says Richard Gallo, MD, PhD, Ima Gigli Distinguished Professor of Dermatology and chair of the Department of Dermatology at UC San Diego School of Medicine. “Previously, it was thought that hair follicles were most important for acne to develop. In this study, we looked at the cells outside of the hair follicle and found they had a major effect on controlling bacteria and the development of acne.”

Cathelicidin being so highly expressed in acne biopsy tissue was a very interesting finding to us,” says Dr. Gallo. “Knowing this will be helpful in developing a more targeted therapy to treat acne.”

Currently, retinoid treatment focuses on controlling the development of lipids in skin cells. One major side effect of these drugs are their teratogenic effects, causing fetal abnormalities in pregnant people. This limits the use of these drugs to only severe cases. The research team hopes these findings may assist in developing a more targeted approach to treating acne.

Phase 2b Study: AOBiome Therapeutics’ Topical B244 Improves Itch, AD

AOBiome Therapeutics’ B244 showed positive results from for both pruritus and atopic dermatitis, according to a Phase 2b trial.

AOBiome’s B244 platform is a patented, proprietary, topical, and intranasal formulation. Once deployed, B244 produces nitric oxide, a signaling molecule known to regulate inflammation and vasodilation. Additionally, recently published immunology data demonstrates that B244 can reduce the inflammatory and pruritic cytokines IL-4, IL-5, IL-13, and IL-31.

The trial enrolled 547 patients with mild to moderate appearance of atopic dermatitis and moderate to severe itch. The trial met all primary and secondary endpoints, showing that B244 significantly reduced itch, reduced overall disease severity, improved skin clearance, and improved health-related quality of life measures at four weeks compared to placebo.

B244 was well tolerated with no SAEs; treatment related treatment emergent adverse events (TEAEs) were low in incidence, mild in severity, and transient. The most common treatment related event was application site pruritus.

“The favorable profile demonstrated in this study for safety and efficacy on both skin lesions and itch fills important unmet needs for first line therapies in atopic dermatitis. Current therapies often do not work or come with significant side effect risks. The efficacy observed for this topical spray after only 4 weeks is exciting for both clinicians and patients. An effective non-steroidal, non-injectable therapy without black box warnings or laboratory monitoring is pretty much the holy grail of unmet need in dermatology” says study author Dr. Jonathan Silverberg, associate professor of dermatology at George Washington School of Medicine and Health Services in Washington, DC.

More Than Half of Postmenopausal Women Experience Female Pattern Hair Loss

More than half of postmenopausal women experience female pattern hair loss, according to a study published online in Menopause.

In a new cross-sectional study involving 178 women seen at a menopause clinic, researchers aimed to evaluate the prevalence of female pattern hair loss in healthy postmenopausal women and investigate postmenopausal hair characteristics as well as the factors associated with female pattern hair loss.

Of the women studied, 52.2 percent were found to have female pattern hair loss. The prevalence of female pattern hair loss increased with age. Low self-esteem was detected in 60 percent of participants and increased with the severity of female pattern hair loss.

The researchers additionally noted that a high body mass index was associated with an increased prevalence and worsening of female pattern hair loss in postmenopausal women. Further studies are necessary to determine whether sex steroid hormones, especially estrogen and testosterone, and a history of polycystic ovary syndrome are related to hair loss in postmenopausal women.

Cetaphil Launches Sensitive Skin Awareness Month

Cetaphil has extended Sensitive Skin Awareness Week to a month-long program. Cetaphil debuts Sensitive Skin Awareness Month this month. In partnership with expert dermatologists and influencers—dubbed the Sensitive Skin Academy—Cetaphil says its goal is to offer the community even more robust education and access to sensitive skin resources.

The Sensitive Skin Academy will share expert knowledge based on four weekly themes, ranging from building a routine to how certain lifestyle choices can impact sensitive skin.

Consumers and physicians can follow along on Instagram @CetaphilUS and head to the dedicated Amazon.com/Cetaphil page for extra content and purchases.

FDA Green-lights Casio’s DZ-D100 Dermocamera and the DZ-S50 Scope

The FDA has cleared Casio’s DZ-D100 Dermocamera and the DZ-S50 scope for skin observation as medical devices. The DZ-D100 and DZ-S50 will be available in the US on Casio America’s e-commerce site this month,

The DZ-D100 was developed in collaboration with dermatology professionals and delivers both standard sized and close-up shots of an affected area with a single unit, and can be used with the D’z Image Viewer, a free downloadable software to manage the captured images.

In March 2020, Casio released the DZ-S50 scope, making skin observation even easier. These Casio products make it simple to take ordinary or standard sized and close-up shots without switching lenses and can capture polarized, non-polarized and UV photos at the same viewpoint with a single click.

Third Harmonic Bio Launches

Third Harmonic Bio is launching with the close of a Series B financing campaign. With total capital to date of $155 million, the company plans to fund development of its lead candidate, THB001, through the next phase of human studies for the initial indication of chronic urticaria.

Atlas Venture founded and seeded Third Harmonic Bio in 2019 and co-led the $50 million Series A with OrbiMed with participation from BVF Partners. Atlas and OrbiMed also participated in the $105 million Series B, which was led by new investor General Atlantic and co-led by existing investor BVF Partners. Additional new investors in the round included Boxer Capital, RA Capital, RTW, Deep Track Capital, Ajax Health/Zeus, and Commodore Capital.

THB001 is a first-in-class, oral small-molecule inhibitor of KIT, a cell surface receptor that serves as the master regulator of mast cell function and survival. Given KIT’s function, its inhibition has the potential to blunt mast cell-driven inflammation regardless of the activating signal source, providing the potential for broad therapeutic utility. A Phase 1b proof-of-concept study in cold-inducible urticaria could begin in the second half of 2022.

CLOSE UP with Alan O’Neill, PhD

Despite decades of research, a lot still remains unknown about the pathogenesis of acne. Now, new research shows that cathelicidin produced in fibroblast cells can help combat infection by suppressing acne-causing bacteria. Here, study author Alan O’Neill, PhD, a project scientist at UC San Diego School of Medicine, discusses the new findings, which appear in the February 16, 2022 issue of Science Translational Medicine.

Why is this topic important to study?

Alan O’Neill, PhD: Acne is one of the most common skin disorders in the world, yet there is still much we don’t really understand. Acne is a very complicated skin condition because it is an inflammatory disorder of the hair follicle, and there are many different factors and cell types involved. However, the role of dermal fibroblasts in acne has been largely overlooked. Our lab has previously found that fibroblasts have an important innate immune defense in the skin against deep tissue infection. Since it is known that C. acnes colonization in the hair follicle is a major contributor to acne development, it suggested to us that fibroblasts may play an important role in this disease.

Describe the research and your findings.

Dr. O’Neill: Our initial aim for this project was to better understand the role of fibroblasts in the pathophysiology of acne. To do this we conducted single-cell tissue analyses on skin biopsies obtained from acne patients. What we found was that an important antimicrobial peptide called cathelicidin was highly expressed in perifollicular fibroblasts. This response was identified as reactive adipogenesis, a process in which fibroblasts transform into immunologically active fat cells. It was a great surprise to see cathelicidin so highly expressed in acne patients because it tells us that there is an antibacterial response in the skin against this condition. In fact, we were able to mimic this response in mice that were injected with C. acnes. Infected mice treated with retinoic acid had greater cathelicidin expression and smaller lesions. When we analyzed skin biopsies of acne patients treated for several months with retinoids, we found that the drug enhanced cathelicidin expression in fibroblasts after treatment, thus finding an additional, unknown mechanism for why retinoids help treat acne. This cell type isn’t particularly well studied in this disease and might represent an important therapeutic target for acne.

What is the next step?

Dr. O’Neill: We now know there is a host response toward the bacteria, but we still need to understand more about the role of fibroblasts in disease development. Fibroblasts are an important source of antimicrobial and immunomodulatory factors as well, so how it interacts with other immune cells and coordinates the overall immune response in acne will be interesting to study.

BTL Cares Scholarship Program

BTL and professional basketball player Andre Drummond have selected the five winners of their first-ever scholarship program—the BTL Scholar Draft.

The program awarded each of the five students a $15,000 grant towards tuition and college fees. The Scholar Draft was started to empower graduating high school and currently enrolled college student-athletes across the country to pursue higher education and strengthen their path to successful future careers. Entrants were asked to submit a two- to five-minute video sharing their aspirations and what confidence in their sport means to them. The material was reviewed by the BTL team and Drummond.

The winners are:

• Alaysia Oakes (Lynchburg, VA)
• Sydney Stapf (West Bloomfield, MI),
• Charity McDowell (Indianapolis, IN)
• Emaria Banks (Loganville, GA)
• Terry Burrel III (Cypress, TX