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A Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Efficacy and Safety of Topical Administration of FMX101 for 12 Weeks in the Treatment of Moderate-to-Severe Acne Vulgaris (Study FX2017-22)

Trial Profile

A Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Efficacy and Safety of Topical Administration of FMX101 for 12 Weeks in the Treatment of Moderate-to-Severe Acne Vulgaris (Study FX2017-22)

Completed
Phase of Trial: Phase III

Latest Information Update: 21 Dec 2018

At a glance

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

    • 21 Dec 2018 According to a Foamix media release, based on the data from FX2014-05 and FX2017-22 studies, the company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for FMX101 for the treatment of inflammatory lesions of non-nodular moderate-to-severe acne vulgaris in patients 9 years of age and older.
    • 29 Oct 2018 Status changed from active, no longer recruiting to completed.
    • 12 Oct 2018 According to a Foamix media release, data from this trial will be presented at the Fall Clinical Dermatology Conference (October 2018).
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