AcneDerm CommunityDermatology Roundup

Dermatology Roundup: Newly FDA-Approved Cheek Filler, Molluscrum Contagiosum Trial Results, Eating Disorders & Acne Vulgaris

By Allison Sit

The Food and Drug Administration has approved Restylane Contour for cheek augmentation and correction of midface contour deficiencies in adults older than 21. Approval of the new hyaluronic acid dermal filler was supported by results of a phase 3 study that found patients treated with Restylane Contour required less total volume injected to achieve optimal aesthetic results compared to the comparator. The study also showed the product was well-tolerated with bruising, redness, swelling, pain, tenderness and itching at the injection site as the most common side effects.

“Cheeks are the cornerstone of the face, and focusing on natural contour and not just volume loss can result in a dynamic expression that amplifies their natural beauty,” said Dr. Leslie Baumann, M.D., in a news release. Dr. Baumann is a board-certified dermatologist in Miami and a lead investigator in the study.

Novan has announced positive topline results from its phase 3 trial of a topical antiviral gel – SB206 — in patients with molluscum contagiosum. B-SIMPLE4, a multi-center, double-blind, randomized vehicle-controlled trial, with 891 patients enrolled, found 32 percent of participants who were treated with SB206 experienced complete clearance of all lesions at week 12, compared with 20 percent in the control group. Forty-four percent of participants treated with SB206 had a lesion count of 0 or 1 at week 12, compared with more than 25 percent in the control group. SB206 was also found to be safe and well tolerated, and no treatment-related serious adverse events were reported. There are currently no FDA approved therapies for the treatment of molluscum.

“I am excited to potentially have a topical treatment that is safe and effective in treating molluscum for my patients,” stated John Browning, MD, FAAD, FAAP, MBA, in a news release. Dr. Browning is an adjunct associate professor of pediatrics and dermatology at UT Health San Antonio and Baylor College of Medicine, and a principal investigator in the B-SIMPLE4 study.

A study in the Journal of Cosmetic Dermatology sought to determine if acne vulgaris is a risk factor for developing eating disorders. Drs. Ümran Öner and Fatmanur Hacinecipoglu aimed to investigate eating disorders in acne patients and evaluate the effect of acne severity, quality of life and body mass index (BMI) on eating disorders. Investigators enrolled 232 acne patients and 314 healthy controls in dermatology clinics and hospitals in Turkey. The acne patients completed the Eating Attitude Test-40 (EAT) and the Acne Quality of Life Scale (AQLS), while the controls completed only EAT. The authors found a significant positive correlation between EAT score and AQLS score but no significant relationship between acne severity and EAT score.

“These findings show that acne vulgaris causes deterioration in eating attitude as it increases the stress level by affecting the quality of life,” the authors wrote. “Therefore, it should be kept in mind that eating attitudes may also be affected in patients with acne vulgaris; in case of doubt, patients should be evaluated multidisciplinary and necessary measures should be taken before the disease reaches desperate dimensions.”