A Study (Study 2) to Evaluate the Safety and Efficacy of FMX103 1.5% Topical Minocycline Foam in the Treatment of Facial Papulopustular Rosacea
Recruiting in Palo Alto (17 mi)
+45 other locations
Age: 18+
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?
The primary objectives of this study are to determine the efficacy and safety of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea.
Research Team
Eligibility Criteria
Inclusion Criteria
At least 15 and not more than 75 facial papules and pustules, excluding lesions involving the eyes and scalp;
No more than 2 nodules on the face.
Presence of or history of erythema and/or flushing on the face.
Treatment Details
Interventions
- FMX103 minocycline foam 1.5% (Tetracycline Antibiotic)
- Vehicle foam (Topical Treatment)
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: FMX103 1.5%Experimental Treatment1 Intervention
Participants will apply the assigned FMX103 minocycline foam 1.5% topically once daily for 12 weeks as directed.
Group II: Vehicle foamPlacebo Group1 Intervention
Participants will apply the assigned vehicle foam topically once daily for 12 weeks as directed.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vyne Therapeutics Inc.
Lead Sponsor
Trials
37
Recruited
9,700+
Premier Research Group plc
Industry Sponsor
Trials
65
Recruited
74,200+
John Ratliff
Premier Research Group plc
Chief Executive Officer since 2024
MBA
Dr. Milena Kanova-Petrova
Premier Research Group plc
Chief Medical Officer since 2024
MD