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

Phase 3 Completed 361 enrolled Sol-Gel Technologies, Ltd.

RandomizedParallel-groupDouble-blindTreatment

Summary

To assess the efficacy and safety of S5G4T-1 compared to its vehicle when applied once daily for 12 weeks in participants with papulopustular rosacea.

Timeline

Start: 2018-06-18
Primary completion: 2019-05-24
Completion: 2019-05-24

Outcome

Met primary endpoint

paper In Study 1, the proportion of subjects achieving IGA clear/almost clear at Week 12 was 43.5 percent for E-BPO cream, 5%, and 16.1 percent for vehicle. PMID 37636253 ↗

paper In Study 2, the respective values were 50.1 percent and 25.9 percent. PMID 37636253 ↗

paper In Study 2, the respective values were -20.3 and -13.3 (all P<0.001). PMID 37636253 ↗

Publications

Bhatia ND, Werschler WP, Baldwin H, Sugarman J, Green LJ, Levy-Hacham O, Nov O, Ram V, Stein Gold L. Efficacy and Safety of Microencapsulated Benzoyl Peroxide Cream, 5%, in Rosacea: Results From Two Phase III, Randomized, Vehicle-Controlled Trials. J Clin Aesthet Dermatol. 2023 Aug;16(8):34-40.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Benzoyl Peroxide	Other / unclassified	5 %	Topical