NCT03271021

A Study to Evaluate the Efficacy and Safety of Topical Administration of FMX101 in the Treatment of Moderate-to-Severe Acne Vulgaris

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,488 (actual)
• Sponsor: Vyne Therapeutics Inc. · Industry
• Sex: All
• Age: 9 Years
• Healthy volunteers: Not accepted

Summary

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)

Detailed description

This is a randomized, multicenter, double-blind, vehicle-controlled, 2 arm study to evaluate the safety and efficacy over 12 weeks of FMX101 topical foam containing 4% minocycline compared to vehicle in the treatment of subjects with moderate-to-severe facial acne vulgaris. Qualified subjects will be randomized to receive 1 of the following 2 treatments: * FMX101 4% minocycline foam * Vehicle foam

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	FMX101	FMX101, 4% minocycline foam
DRUG	Vehicle Foam	Vehicle Foam

Timeline

• Start date: 2017-07-17
• Primary completion: 2018-09-04
• Completion: 2018-09-04
• First posted: 2017-09-01
• Last updated: 2022-01-18
• Results posted: 2020-02-21

Locations

98 sites across 1 country: United States

Regulatory

• FDA-regulated drug study