At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 504 enrolled
Drug / intervention
FMX103 1.5%drug
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.
An Open-Label Study to Evaluate the Long-Term Safety of Topical Administration of FMX103 for 40 Weeks in the Treatment of Moderate to Severe Facial Papulopustular Rosacea (Study FX2016-13)
In Brief
A Phase 3 clinical trial evaluating FMX103 1.5% for Papulopustular Rosacea. Completed, enrolled 504 participants across 79 sites.
Detailed Summary
The primary objective is to show that open-label extended treatment with FMX103 1.5%, for up to an additional 40 weeks, is safe and well tolerated.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPapulopustular Rosacea
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
Enrollment StartSep 2017
First PostedSep 2017
Primary CompletionJan 2019
Study CompletionJan 2019
TodayJul 2026
First PostedSep 8, 2017
Enrollment StartSep 5, 2017
Primary CompletionJan 3, 2019
Study CompletionJan 15, 2019
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 8.8 years ago
Interventions
FMX103 1.5%drug
FMX103 1.5% minocycline foam