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A Randomized, Multicenter, Double-blind, Vehicle-controlled Study to Evaluate the Safety and Efficacy of FMX103 1.5% Topical Minocycline Foam Compared to Vehicle in the Treatment of Facial Papulopustular Rosacea (FX2016-12)

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A Randomized, Multicenter, Double-blind, Vehicle-controlled Study to Evaluate the Safety and Efficacy of FMX103 1.5% Topical Minocycline Foam Compared to Vehicle in the Treatment of Facial Papulopustular Rosacea (FX2016-12)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 20 May 2021

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At a glance

  • Drugs Minocycline (Primary)
  • Indications Rosacea
  • Focus Registrational; Therapeutic Use
  • Sponsors VYNE Therapeutics

    • Most Recent Events

    • 28 Oct 2020 Status changed from active, no longer recruiting to completed.
    • 29 May 2020 According to a Menlo Therapeutics media release, the U.S. FDA has approved ZILXI (minocycline) topical foam, 1.5%, for the treatment of inflammatory lesions of rosacea in adults.The FDA approval of ZILXI is primarily supported by data from two clinical trials in 1522 patients 18 years of age and older.
    • 18 Feb 2020 Results published in the Foamix Media Release

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