CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 958 enrolled
Drug / intervention
Tretinoin +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.

Search/NCT01243450
NCT01243450Phase 3Completed
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Bioequivalence Study of Generic Tretinoin 0.04% Microsphere Gel, 0.04% Retin-A Micro® and Placebo

Spear Pharmaceuticals·interventional·Posted Nov 18, 2010·Updated Jan 3, 2020

In Brief

A Phase 3 clinical trial evaluating Tretinoin and placebo for Acne. Completed, enrolled 958 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
First PostedNov 18, 2010
Enrollment StartOct 1, 2009
Primary CompletionOct 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 15.6 years ago

Interventions

Tretinoindrug

Treatment of acne

placebodrug

treatment of acne