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An Open-Label Study to Evaluate the Long-Term Safety of Topical Administration of FMX103 for 40 Weeks in the Treatment of Moderate to Severe Facial Papulopustular Rosacea (Study FX2016-13)

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Trial Profile

An Open-Label Study to Evaluate the Long-Term Safety of Topical Administration of FMX103 for 40 Weeks in the Treatment of Moderate to Severe Facial Papulopustular Rosacea (Study FX2016-13)

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 Foamix

    • Most Recent Events

    • 01 Dec 2020 According to a VYNE Therapeutics media release, the company announced the peer reviewed publication of long-term safety and efficacy data for ZILXI™ (minocycline) topical foam, 1.5% in the Journal of Clinical and Aesthetic Dermatology (JCAD).
    • 01 Dec 2020 Results published in the VYNE Therapeutics Media Release
    • 18 Oct 2019 According to a Foamix media release, the U.S. Food and Drug Administration (FDA) has approved its novel AMZEEQTM (minocycline) topical foam, 4%. AMZEEQ, formerly known as FMX101, is indicated for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in adults and pediatric patients 9 years of age and older.

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