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A Randomized, Double-Blind Study to Compare the Efficacy, Safety and Long-Term Safety of Topical Administration of FMX-101 for 1 Year in the Treatment of Moderate-to-Severe Acne Vulgaris, Study FX2014-04

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Trial Profile

A Randomized, Double-Blind Study to Compare the Efficacy, Safety and Long-Term Safety of Topical Administration of FMX-101 for 1 Year in the Treatment of Moderate-to-Severe Acne Vulgaris, Study FX2014-04

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 20 May 2021

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At a glance

  • Drugs Minocycline (Primary)
  • Indications Acne vulgaris
  • Focus Registrational; Therapeutic Use
  • Sponsors Foamix

Most Recent Events

  • 11 Nov 2019 According to a Foamix media release, AMZEEQ will be luanched in USA in January 2020.
  • 04 Nov 2019 According to a Foamix media release, Studies 04 and 05 were conducted by Foamix to support the New Drug Application submission of AMZEEQ (minocycline) topical foam, which was approved by the U.S. Food and Drug Administration (FDA) for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older.
  • 04 Nov 2019 According to a Foamix media release, the long term open label safety portions of studies FX2014-04 and FX2014-05 (Studies 04 & 05) were published in the Journal of Clinical and Aesthetic Dermatology (JCAD).

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