At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 480 enrolled
Drug / intervention
Tretinoin microsphere 0.1% +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.
Bioequivalence Study of Generic Tretinoin 0.1% Microsphere Gel, 0.1% Retin-A Micro® and Placebo
In Brief
A Phase 3 clinical trial evaluating Tretinoin microsphere 0.1%, Brand Retin-A Micro tretinoin microsphere gel 0.1%, and 1 other intervention for Acne. Completed, enrolled 480 participants across 1 site.
Detailed Summary
The objective will be to assess clinical bioequivalence of 0.1% Retin-A Micro® Gel and Spear Pharmaceutical's generic 0.1% Tretinoin Microsphere Gel with a placebo arm.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcne
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2009
Primary CompletionApr 2010
First PostedJun 2010
TodayJul 2026
First PostedJun 2, 2010
Enrollment StartOct 1, 2009
Primary CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 16.1 years ago
Interventions
Tretinoin microsphere 0.1%drug
Treatment of acne vulgaris
Brand Retin-A Micro tretinoin microsphere gel 0.1%drug
Treatment of acne vulgaris
placebo microsphere geldrug
treatment of acne vulgaris