Finacea Foam 15% Approved for Mild to Moderate Rosacea
The FDA approved Finacea® (azelaic acid) Foam, 15% for the topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. The approval is based on results from two pivotal clinical trials examining the efficacy and safety of Finacea® Foam compared to foam vehicle in the topical treatment of papulopustular rosacea.
In the two clinical trials, treatment with Finacea® Foam resulted in a higher Investigator’s Global Assessment (IGA) success rate compared to vehicle control (32.1% vs. 23.4% in trial 1 and 43.4% vs. 32.5% in trial 2), as well as a greater reduction in the mean nominal change of inflammatory lesion count from baseline to the end of the 12-week treatment period (-13.2 vs. -10.3 in trial 1 and -13.3 vs. -9.5 in trial 2).
Cellfina Cleared to Treat Cellulite for Up to Two Years
The Cellfina System from Ulthera, Inc. has received FDA clearance for the long-term improvement in the appearance of cellulite on the buttocks and thighs with no loss of benefit for up to two years. Ulthera is a wholly-owned subsidiary of Merz, Inc. The Cellfina™ System will be available to physicians across the US this fall.
Cellfina is the only FDA-cleared minimally invasive procedure clinically proven to improve the appearance of cellulite for results that last at least two years, the longest duration cleared by the FDA. The Cellfina System combines proprietary technology with subcision, to treat the primary structural cause of cellulite.
ASDS Skin Cancer Program Honored
A skin cancer screening program offered by the American Society for Dermatologic Surgery (ASDS) has been commended with a national 2015 Power of A award for “helping to make the world a better place.” The Choose Skin Health program has been named a Power of A Gold Award winner by the American Society of Association Executives. Power of A recognizes organizations annually that “distinguish themselves with innovative, effective and broad-reaching programs and activities that positively impact America and the world.” Choose Skin Health, now in its sixth year, is a joint effort between ASDS and Neutrogena. ASDS members volunteer to provide free skin cancer screenings and work to educate people about the importance of early detection. Neutrogena offers members a variety of supplies at no cost to use for the screenings, including forms, brochures, sunscreen samples, and marketing materials.
Combination Melanoma Treatment Receives FDA Priority Review Designation
The FDA has granted priority review for the combination of Novartis’ Tafinlar (dabrafenib) and Mekinist (trametinib) for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. Current approval is contingent on the results of the COMBI-d study, which showed that among study participants the combination of Tafinlar and Mekinist achieved a statistically significant overall survival benefit compared to Tafinlar monotherapy.
Galderma Receives FDA Approval for Epiduo Forte for Acne
The FDA approved Galderma’s antibiotic-free Epiduo® Forte (adapalene and benzoyl peroxide) Gel, 0.3%/2.5%, for the once-daily, topical treatment of acne vulgaris. Epiduo Forte Gel is the first combination of these strengths of the retinoid, adapalene, and benzoyl peroxide, developed for the moderate to severe acne population. The approval was based on a pivotal phase 3, multicenter, randomized, double-blind, 12-week, vehicle-controlled study in which it met each of its primary efficacy endpoints when compared to vehicle gel in 217 acne patients. The study demonstrated superiority of Epiduo Forte Gel over vehicle gel in the overall study population (moderate to severe) at week 12 for the Investigator’s Global Assessment Success Rate and for changes in inflammatory and non-inflammatory lesion counts. Additionally, subjects who were “severe” at baseline (50 percent) were required to go from “severe” to “clear” or “almost clear” within the 12-week trial to be considered a treatment success. More than half of study subjects treated with Epiduo Forte Gel reported a marked improvement in their severe acne.
National Psoriasis Foundation Launches Patient-centered Research Platform
Patients with psoriasis and psoriatic arthritis can contribute directly to the future of research into these chronic, systemic autoimmune diseases, the the National Psoriasis Foundation says. through its patient-centered research network called Citizen Pscientist. This online, interactive community, allows people living with psoriatic disease to connect with researchers, share their data and get input from others in the community, and ultimately drive the direction of psoriatic disease research. Learn more at www.citizenpscientist.org.
The NPF explains that the platform unites psoriatic disease patients from around the country to contribute their own data about triggers, treatments, associated health conditions and lifestyle factors related to psoriasis and psoriatic arthritis. As Citizen Pscientists, the group serves as both the subject and the scientist by exploring data presented by others in the community, forming their own hypotheses and questions, and analyzing the data through visualization tools.
For more information, visit www.psoriasis.org. n