At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 961 enrolled
Drug / intervention
Azelaic acid foam, 15% (BAY39-6251) +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, Vehicle-controlled, Multicenter, Parallel-group Clinical Trial to Assess the Safety and Efficacy of Azelaic Acid Foam, 15% Topically Applied Twice Daily for 12 Weeks in Subjects With Papulopustular Rosacea
In Brief
A Phase 3 clinical trial evaluating Azelaic acid foam, 15% (BAY39-6251) and Vehicle foam for Papulopustular Rosacea. Completed, enrolled 961 participants across 49 sites.
Detailed Summary
The purpose of this study is to assess the safety and efficacy of azelaic acid (AzA) foam, 15% topically applied twice daily for 12 weeks in subjects with papulopustular rosacea compared to its vehicle.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPapulopustular Rosacea
CountriesUnited States
CollaboratorsBayer
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 2012
Enrollment StartSep 2012
Primary CompletionJan 2014
TodayJul 2026
First PostedMar 15, 2012
Enrollment StartSep 1, 2012
Primary CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 14.3 years ago
Interventions
Azelaic acid foam, 15% (BAY39-6251)drug
Azelaic acid twice daily topical application
Vehicle foamdrug
twice daily topical application