A Study to Compare the Efficacy and Safety of Topical Administration of FMX-101 for Treatment of Moderate-to-Severe Acne
Recruiting in Palo Alto (17 mi)
+34 other locations
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Vyne Therapeutics Inc.
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
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.
Research Team
Eligibility Criteria
Inclusion Criteria
20 to 50 inflammatory lesions (papules, pustules, and nodules)
25 to 100 noninflammatory lesions (open and closed comedones)
No more than 2 nodules on the face
See 2 more
Treatment Details
Interventions
- FMX-101 (Tetracycline Antibiotic)
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: FMX-101, 4% minocycline foamExperimental Treatment1 Intervention
FMX-101, 4% minocycline foam applied topically once daily for 12 weeks
Group II: Vehicle FoamPlacebo Group1 Intervention
Vehicle foam applied topically once daily for 12 weeks
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vyne Therapeutics Inc.
Lead Sponsor
Trials
37
Recruited
9,700+