NCT04960930

To Evaluate the Efficacy and Safety of Minocycline Hydrochloride Foam in the Treatment of Moderate-to-severe Acne Vulgaris

A Phase 3, Multi-center, Randomized, Double-Blind, Vehicle-controlled Study to Evaluate the Efficacy and Safety of Topical Administration of Minocycline Hydrochloride Foam (4%) in the Treatment of Moderate-to-Severe Acne Vulgaris

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 372 (actual)
• Sponsor: Cutia Therapeutics (Shanghai) Co., Ltd · Industry
• Sex: All
• Age: 9 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, multicenter, double-blind, vehicle-controlled, 2-arm study to evaluate the safety and efficacy in 12 weeks of FMX101 minocycline foam, 4%, compared to vehicle, in the treatment of subjects with moderate to severe facial acne vulgaris.

Detailed description

Qualified subjects will be randomized to receive 1 of the following 2 treatments: * FMX101 4% minocycline foam * Vehicle foam Subjects with qualifying lesion counts and Investigator's Global Assessments (IGA) of acne severity scores and will be assigned to 1 of 2 treatments according to the randomization schedule. Subjects will apply the assigned study drug topically once daily for 12 weeks as directed. Subjects will be advised to apply the study drug at approximately the same time each day, preferably in the evening at bedtime. Both the Investigator and subject will be blinded to the study drug identity. Subjects will return for visits at Weeks 1, 2, 4, 6, 8, and 12. At the discretion of the clinic staff, for the convenience of subjects or clinic staff, visits can be scheduled to occur 2 days before or after the nominal schedule date for the Weeks 1, 2, 4, 8 and 12 visits. Efficacy evaluations (acne lesion counts and IGAs) will be performed at each visit during the study.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	FMX101	topically once daily

Timeline

• Start date: 2021-09-17
• Primary completion: 2022-09-27
• Completion: 2022-10-14
• First posted: 2021-07-14
• Last updated: 2023-09-28

Locations

29 sites across 1 country: China