Sol-Gel Technologies has dosed the first patient in a pivotal Phase III clinical trial programme designed to analyse the safety and efficacy of Epsolay (formerly VERED) for the treatment of patients with papulopustular rosacea, also known as subtype II rosacea.
The programme is being carried out following Special Protocol Assessment (SPA) agreements with the US Food and Drug Administration (FDA) regarding the design of the trials.
It includes two randomised, multi-centre, double-blind, vehicle-controlled clinical trials, which are expected to enrol a total of 700 subjects at 50 sites in the US.
Each of the trials expect to include half of the enrolled subjects in a 2:1 ratio of Epsolay in comparison to its vehicle, with a power of greater than 99%.
The trials’ primary efficacy goals are success in Investigator Global Assessment (IGA), measured as a two-grade reduction in IGA on a scale of zero to four with ‘clear’ or ‘almost clear’ at week 12, and a decrease in mean inflammatory lesion count at week 12.
Top-line data from both the trials are slated to be reported next year.
Sol-Gel Technologies CEO Dr Alon Seri-Levy said: “The initiation of our pivotal Phase III clinical programme for Epsolay is an important milestone in our development programme and in introducing our proprietary silica-based microencapsulation delivery system to topical drugs.
“Epsolay is aimed to address the need for more effective treatments for inflammatory papules and pustules of rosacea, a chronic condition for which patients often have low adherence to current drugs.”
Papulopustular rosacea is a chronic, inflammatory skin condition that mostly affects the face.
Epsolay is a once-daily topical cream that features encapsulated benzoyl peroxide, and has been developed using Sol-Gel’s proprietary microencapsulation technology.