At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 466 enrolled
Drug / intervention
FMX-101, 4% minocycline foam +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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 FX2014-04
In Brief
A Phase 3 clinical trial evaluating FMX-101, 4% minocycline foam and Vehicle Foam for Acne Vulgaris. Completed, enrolled 466 participants across 31 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcne Vulgaris
CountriesDominican Republic, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartMay 2016
First PostedJun 2016
Primary CompletionOct 2017
TodayJul 2026
First PostedJun 28, 2016
Enrollment StartMay 1, 2016
Primary CompletionOct 13, 2017
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 10.0 years ago
Interventions
FMX-101, 4% minocycline foamdrug
FMX-101, 4% minocycline foam applied topically once daily for 12 weeks
Vehicle Foamdrug
Vehicle foam applied topically once daily for 12 weeks