At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 862 enrolled
Drug / intervention
Onexton +2 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.
Multicenter, Double-blind, Randomized, Parallel-group, Placebo-controlled Study to Evaluate the Bioequivalence of a Generic Clindamycin 1.2% and Benzoyl Peroxide 3.75% Gel to Onexton® Gel in Subjects With Acne Vulgaris
In Brief
A Phase 3 clinical trial evaluating Onexton, Clindamycin/benzoyl peroxide gel, and 1 other intervention for Acne Vulgaris. Completed, enrolled 862 participants across 17 sites.
Detailed Summary
Actavis has developed a generic formulation of clindamycin 1.2% and benzoyl peroxide 3.75% gel. This study is designed to evaluate the safety and efficacy of this formulation in subjects with Acne Vulgaris
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcne Vulgaris
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartMay 2015
Primary CompletionOct 2015
Study CompletionNov 2015
First PostedNov 2015
TodayJul 2026
First PostedNov 30, 2015
Enrollment StartMay 1, 2015
Primary CompletionOct 1, 2015
Study CompletionNov 1, 2015
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 10.6 years ago
Interventions
Onextondrug
Topical gel for treating acne
Clindamycin/benzoyl peroxide geldrug
Generic Clindamycin/benzoyl peroxide gel for treating acne
Placebodrug
Vehicle gel used as a placebo