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A Phase 3 Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study of S6G5T-3 in the Treatment of Acne Vulgaris

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Trial Profile

A Phase 3 Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study of S6G5T-3 in the Treatment of Acne Vulgaris

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 11 Jun 2023

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At a glance

  • Drugs Benzoyl peroxide/tretinoin (Primary)
  • Indications Acne vulgaris
  • 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 TWYNEO for the Canadian market.Both companies are looking to anticipates filing of Canadian regulatory submissions in early 2024 and looking to commercialize TWYNEO (tretinoin, 0.1%, and benzoyl peroxide, 3%, cream) in Canada over a fifteen-year term that is renewable for subsequent five-year periods.
    • 27 Jul 2021 According to a Sol-Gel Technologies media release, based on results from the NCT03761784, and NCT03761810 trials the FDA has approved TWYNEO (tretinoin/benzoyl peroxide) cream, 0.1%/3%, indicated for the treatment of acne vulgaris in adults and pediatric patients nine years of age and older.
    • 17 Mar 2020 Status changed from recruiting to completed.

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