Described in the official trial only as a “topical cream”, Sol-Gel are undergoing a Phase 3 trial for a product newly designated as S5G4T-1.

What is S5G4T-1? (Now Epsolay)

Although the clinical trial listing doesn’t provide any details about the components of S5G4T-1, their own web site reveals more information. Based on Sol-Gel’s product portfolio, it seems clear that S5G4T-1 is called VERED internally.

VERED is Sol-Gel’s uniquely packaged formulation of 5% benzoyl peroxide cream. Well known as an acne treatment, bezoyl peroxide can be too harsh as a rosacea treatment.

Sol-Gel has previously called this product DER 45 EV, and has been covered previously in Rosacea News – in 2009 Sol-Gel Trialling Benzoyl Peroxide (DER 45 EV) for Rosacea and 2012 Sol-Gel Releases E-BPO Phase 2 Trial Notes.

Sol-Gel VERED 

VERED is an innovative topical encapsulated benzoyl peroxide cream with a 5% concentration for the treatment of papulopustular rosacea.

Benzoyl peroxide is known to be an effective treatment for rosacea, but causes significant irritation.

Our silica-based microencapsulation delivery system creates a silica barrier between benzoyl peroxide crystals and the skin, and as a result is expected to reduce irritation typically associated with topical application of benzoyl peroxide, thereby making the drug tolerable to rosacea-affected skin.

Our solution also alters the release profile of the drug substance to reduce skin irritation while maintaining efficacy.

In a double-blind, randomized, dose-ranging Phase II clinical trial for VERED, involving 92 adult patients at ten centers in the U.S., VERED demonstrated statistically significant efficacy versus the control vehicle.

Moreover, the safety and tolerability profile of VERED was similar to that of the vehicle. In the first half of 2018, we expect to commence two double-blind, placebo controlled, multi-center pivotal Phase III clinical trials for VERED in the U.S, with results within one year after commencement.

Clinical Trial Listing

Clinical Trial NCT03448939

A Study of S5G4T-1 in the Treatment of Papulopustular Rosacea

To assess the efficacy and safety of S5G4T-1 compared to S5G4T-1 Vehicle when applied once daily for 12 weeks in patients with papulopustular rosacea

Sponsor: Sol-Gel Technologies, Ltd.

Detailed Description: In this Phase 3, double blind, vehicle controlled study, patients will be admitted into this multi center, double blind, randomized, vehicle controlled, parallel group pivotal study only after a written informed consent has been obtained and after all inclusion/exclusion criteria have been met. Male and female patients at least 18 years of age with moderate or severe papulopustular rosacea will be eligible for enrollment for daily treatment with S5G4T-1 or its vehicle for 12 weeks.