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A Phase 3 Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study of S5G4T-1 in the Treatment of Papulopustular Rosacea

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Trial Profile

A Phase 3 Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study of S5G4T-1 in the Treatment of Papulopustular Rosacea

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 29 Oct 2025

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At a glance

  • Drugs Benzoyl peroxide (Primary)
  • Indications Rosacea
  • Focus Registrational; Therapeutic Use
  • Sponsors Sol-Gel Technologies

Most Recent Events

  • 04 Sep 2025 According to a Sol-Gel Technologies media release, Health Canada issued a Notice of Compliance (NOC) on August 27, 2025 for EPSOLAY for the treatment of inflammatory lesions of rosacea in adults.
  • 06 Jun 2023 According to a Sol-Gel Technologies media release, Israel Sol-Gel Technologies, Ltd. and Searchlight Pharma Inc. have signed exclusive license agreements for EPSOLAY for the Canadian market.Both companies are looking to anticipates filing of Canadian regulatory submissions in early 2024 and looking to commercialize EPSOLAY (benzoyl peroxide, 5%, cream) in Canada over a fifteen-year term that is renewable for subsequent five-year periods.
  • 25 Apr 2022 According to a Sol-Gel Technologies media release, based on the two identical phase III trials(NCT03448939, NCT03564119), the Food and Drug Administration (FDA) has approved EPSOLAY, a proprietary cream formulation of benzoyl peroxide, 5%, for the treatment of inflammatory lesions of rosacea in adults.

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