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)
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
- 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).
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History