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A Prospective, Multicenter, Randomized, Double-Blind, Vehicle-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of a Combination of 3% Minocycline and 0.3% Adapalene Topical Foam Formulation for the Treatment of Moderate-to-Severe Acne (Study FX2016 40)

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Trial Profile

A Prospective, Multicenter, Randomized, Double-Blind, Vehicle-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of a Combination of 3% Minocycline and 0.3% Adapalene Topical Foam Formulation for the Treatment of Moderate-to-Severe Acne (Study FX2016 40)

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 20 May 2021

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At a glance

  • Drugs Adapalene/minocycline (Primary) ; Adapalene; Minocycline
  • Indications Acne vulgaris
  • Focus Therapeutic Use
  • Sponsors Foamix

Most Recent Events

  • 17 Dec 2020 According to a VYNE Therapeutics media release, based on the results of this phase 2 study, the non-clinical safety and CMC, the company has completed the End-of-Phase 2 Meeting with the USA Food and Drug Administration (FDA). The meeting has provided the clear direction on the Phase 3 clinical and pharmaceutical development plans for FCD105.
  • 27 Jul 2020 Status changed from active, no longer recruiting to completed.
  • 02 Jun 2020 According to a Menlo Therapeutics media release, Primary endpoint (Investigators Global Assessment (IGA) Treatment Success at Week 12) has been met.

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