FDA Approves Benzoyl Peroxide Cream for Treatment of Inflammatory Lesions of Rosacea


With Epsolay treatment, inflammatory lesions of rosacea were reduced by nearly 70% by the end of both 12-week trials compared with a 38% to 46% reduction with the vehicle cream.

The FDA has approved benzoyl peroxide cream 5% (Epsolay; Sol-Gel Technologies and Galderma) for the treatment of inflammatory lesions of rosacea in adults, according to a press release.

The benzoyl peroxide in Epsolay is encapsulated within silica-based patented microcapsules and is designed to slowly release benzoyl peroxide over time to provide a favorable efficacy and safety profile, according to the manufacturers. The approval is supported by data from 2 positive, identical phase 3 randomized, double-blind, multicenter, 12-week clinical trials that evaluated Epsolay in individuals with inflammatory lesions of rosacea.

“People with rosacea experience a significant burden of disease with diminished quality of life and the approval of Epsolay represents an important advancement for those who are living with rosacea,” said Baldo Scassellati Sforzolini, MD, PhD, global head of research and development at Galderma, in the press release.

The coprimary endpoints in both trials were the proportion of subjects with treatment success and the absolute change from baseline in lesion counts at week 12. According to the researchers, Epsolay was more effective than vehicle cream on the co-primary efficacy endpoints starting from 4 weeks of treatment in both trials.

With Epsolay treatment, inflammatory lesions of rosacea were reduced by nearly 70% by the end of both 12-week trials compared with a 38% to 46% reduction with the vehicle cream. Nearly 50% of subjects were deemed clear or almost clear at 12 weeks compared with 38% to 46% with placebo. Post-hoc analysis of lesion count and IGA success at week 2 confirmed a significantly greater treatment effect for Epsolay relative to vehicle as early as week 2 and in the open-label extension, 73% of subjects were clear or almost clear at 52 weeks.

“Having Epsolay approved by the FDA is a watershed moment for the 16 million people in the United States suffering from rosacea,” said Alon Seri-Levy, PhD, chief executive officer at Sol-Gel, in the press release. “Based on the robust clinical data, we believe that Epsolay has the potential to change the treatment landscape.”

Epsolay is a topical cream containing benzoyl peroxide 5% for the treatment of inflammatory lesions of rosacea. Hypersensitivity, skin irritation or contact dermatitis, and photosensitivity have been reported. The most common adverse events were application site reactions, including pain (2%), erythema (2%), pruritis (1%), and edema (1%).

“There is poor adherence of my patients to current treatments for inflammatory rosacea and I look forward to being able to prescribe Epsolay to them, primarily because Epsolay has demonstrated outstanding and rapid efficacy results and also because Epsolay has been shown to be well-tolerated, both of which are important factors to ensure patients’ satisfaction,” said Neal D. Bhatia, MD, a dermatologist at Therapeutics Clinical Research, in the press release.


Sol-Gel Technologies and Galderma Announce FDA Approval of Epsolay. News release. Sol-Gel; April 25, 2022. Accessed April 26, 2022. https://www.globenewswire.com/news-release/2022/04/25/2427977/0/en/Sol-Gel-Technologies-and-Galderma-Announce-FDA-Approval-of-EPSOLAY.html

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