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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: 11 Jun 2023

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At a glance

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

    • Most Recent Events

    • 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.
    • 21 Dec 2021 According to a Sol-Gel Technologies media release, the Food and Drug Administration (FDA) has informed the Company that it intends to conduct a pre-approval inspection of the production site for EPSOLAY during the week of February 14th, 2022.

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