Sol-Gel Technologies announced positive results of a phase 3 clinical trial for Epsolay in the treatment of papulopustular rosacea.
In two 12-week clinical studies, SGT 54-01 and SGT 54-02, Epsolay (microencapsulated benzoyl peroxide cream, 5%) demonstrated superior efficacy compared with vehicle treatment groups. Improvement among patients treated with benzoyl peroxide cream was statistically significant in the number of those achieving “clear” or “almost clear” skin in the Investigator’s Global Assessment (IGA) and the absolute mean reduction from baseline in inflammatory lesion count, according to a press release.
In two identical, double-blind, vehicle-controlled phase 3 trials, 733 adult patients were enrolled across 54 sites in the U.S. for 12 weeks.
Patients were randomly assigned at a 2:1 ratio for once-daily treatment with benzoyl peroxide cream (n = 493) or vehicle cream (n = 240).
In those treated with benzoyl peroxide cream, clear or almost clear skin was achieved at week 12 in 43.5% of 243 patients in the SGT 54-01 trial (P .001) and 50.1% of 250 patients in SGT 54-02 (P .001). In the vehicle cream groups, 16.1% of 118 patients and 25.9% of 122 patients achieved clear or almost clear skin in the two trials, respectively.
The absolute mean change in inflammatory lesions of patients treated with benzoyl peroxide cream in the SGT 54-01 and SGT 54-02 trials was –17.4 and –20.3 (P .001) vs. –9.5 and –13.3 (P .001) in the vehicle cream groups.
“It’s exciting that Epsolay delivered outstanding and rapid efficacy with a microencapsulated benzoyl peroxide without irritating the sensitive skin of rosacea patients. These findings are extremely positive and, if Epsolay is approved, it has the potential to represent a significant advance in the treatment of papulopustular rosacea,” James J. Leyden, MD, dermatologist and emeritus professor of dermatology at the University of Pennsylvania, said in the release.
Epsolay achieved statistically significant results as early as week 2 of the trial. Its microencapsulation technology addresses safety and tolerability by stabilizing active drug ingredients, extending delivery time and reducing irritation, according to the release.
“That a quarter of Epsolay patients in both trials reached their treatment goals within a month, when the efficacy of existing topical products can be quite slow, is clinically meaningful and illustrates a clear unmet need within a rapidly growing marketplace,” said Alon Seri-Levy, PhD, CEO of Sol-Gel.