NCT02815280

A Study to Compare the Efficacy and Safety of Topical Administration of FMX-101 for Treatment of Moderate-to-Severe Acne

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 FX2014-05

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 495 (actual)
• Sponsor: Vyne Therapeutics Inc. · Industry
• Sex: All
• Age: 9 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 3 study to evaluate the efficacy, safety and long-term safety of the topical administration of FMX-101, 4% minocycline foam for the treatment of moderate-to-severe acne vulgaris.

Detailed description

This is a Phase 3 study to evaluate the efficacy, safety and long-term safety of the topical administration of FMX-101, 4% minocycline foam for the treatment of moderate-to-severe acne vulgaris. The first 12 weeks of the study involves randomized, double-blind treatment with active FMX-101, 4% or matching vehicle. Subjects who successfully complete the 12-week double blind portion of the study will be offered the opportunity to continue in the trial for up to an additional 40 weeks (for a total of 1 year) and receive open-label treatment with FMX-101, 4%.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	FMX-101, 4% minocycline foam	FMX-101, 4% minocycline foam applied topically once daily for 12 weeks
DRUG	Vehicle Foam	Vehicle foam applied topically once daily for 12 weeks

Timeline

• Start date: 2016-05-01
• Primary completion: 2017-10-13
• Completion: 2017-10-13
• First posted: 2016-06-28
• Last updated: 2022-01-18
• Results posted: 2020-11-24

Locations

36 sites across 2 countries: United States, Dominican Republic