At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 574 enrolled
Drug / intervention
Tretinoindrug
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 Tretinoin Gel 0.05% to Brand Tretinoin Gel
In Brief
A Phase 3 clinical trial evaluating Tretinoin for Acne. Completed, enrolled 574 participants.
Detailed Summary
This was a double-blind, randomized, three-treatment, parallel study. Normal, healthy male and female children and adults (i.e., ages 12 to 40 years) with at least Grade 2 (i.e., mild severity) acne vulgaris were treated on the full face once daily for 84 days with the Tretinoin Gel 0.05%, Brand (tretinoin) Gel 0.05%, or Gel Vehicle. Acne lesions were graded by a single blinded observer at screening and at Weeks 0 (i.e., baseline), 2, 4, 8, and 12 at each location.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcne
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartNov 2013
Primary CompletionJun 2014
First PostedSep 2014
TodayJul 2026
First PostedSep 26, 2014
Enrollment StartNov 1, 2013
Primary CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 11.8 years ago
Interventions
Tretinoindrug
Treatment of acne once daily in evening