Sol-Gel Technologies announced positive results from its Phase 3 program evaluating Epsolay microencapsulated benzoyl peroxide cream, 5%, made with the Company’s proprietary microencapsulation technology, for the treatment of papulopustular rosacea. The results are from two 12-week clinical studies, SGT 54-01 and SGT 54-02.
SGT 54-01 and SGT 54-02 were identical, double-blind, vehicle-controlled trials which enrooled 733 patients aged 18 and older with moderate-to-severe papulopustular rosacea at 54 sites across the U.S. Patients were randomized at a 2:1 ratio to be treated once-daily with either Epsolay (n=493) or vehicle cream (n=240) for 12 weeks. After the initiation of treatment, clinical and safety evaluations were performed at Weeks 2, 4, 6, 8 and 12. The primary efficacy endpoints for both trials were success in IGA score at Week 12, defined as “clear” (0) or almost clear” (1) on a scale of 0 to 4, and a reduction in absolute mean inflammatory lesion count at week 12.
In SGT 54-01 the proportion of patients achieving “clear” or “almost clear” at Week 12 was 43.5% for Epsolay versus 16.1% for vehicle and the absolute mean change in inflammatory lesion count from baseline at week 12 was -17.4 for the Epsolay arm versus -9.5 for the vehicle arm.
In SGT 54-02 the proportion of patients achieving “clear” or “almost clear” at Week 12 was 50.1% for Epsolay versus 25.9% for vehicle and the absolute mean change in inflammatory lesion count from baseline at week 12 was -20.3 for the Epsolay arm versus -13.3 for the vehicle arm.
Epsolay was generally safe and well-tolerated with a low rate of cutaneous side effects (e.g., dryness, scaling, itching and burning/stinging) comparable to vehicle. Adverse events were primarily mild to moderate in severity with the most frequently reported adverse events across both studies being application site erythema and application site pain.
About Papulopustular Rosacea
Papulopustular rosacea is a chronic and recurrent inflammatory skin disorder that affects nearly 5 million Americans. The condition is common, especially in fair-skinned people of Celtic and northern European heritage. Onset is usually after age 30 and typically begins as flushing and subtle redness on the cheeks, nose, chin or forehead. If left untreated, rosacea can slowly worsen over time. As the condition progresses the redness becomes more persistent, blood vessels become visible and pimples often appear. Other symptoms may include burning, stinging, dry skin, plaques and skin thickening.
About Epsolay (microencapsulated benzoyl peroxide cream, 5%)
Epsolay is a topical cream containing microencapsulated benzoyl peroxide, 5%. Epsolay utilizes a patented technology process to encapsulate benzoyl peroxide within silica microcapsules to create a barrier between the medication and the skin. The slow migration of medication from the microcapsules delivers treatment doses onto the skin, while the barrier reduces the ability of benzoyl peroxide to induce the strong oxidation process that can result in significant skin irritation, such as erythema, burning and stinging. Silica is chemically inert, photochemically and physically stable, and is safely used in topical products.