CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,125 enrolled
Drug / intervention
Clindamycin 1% Gel +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/NCT03522441
NCT03522441Phase 3Completed
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A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing Clindamycin 1% Gel To Clindamycin 1% Gel (Greenstone LLC) and Both Active Treatments to Vehicle Control in the Treatment of Acne Vulgaris

Akorn, Inc.·interventional·Posted May 11, 2018·Updated Oct 5, 2020

In Brief

A Phase 3 clinical trial evaluating Clindamycin 1% Gel and Placebo for Acne Vulgaris. Completed, enrolled 1,125 participants across 12 sites in 2 countries.

Detailed Summary

This is a randomized, double-blind, multiple-site, placebo-controlled, parallel-group study, designed to compare the efficacy and safety of generic Clindamycin 1% gel (Akorn), and the marketed product Clindamycin 1% gel (Greenstone LLC) in the treatment of acne vulgaris.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcne Vulgaris
CountriesBelize, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedMay 11, 2018
Enrollment StartApr 27, 2018
Primary CompletionApr 22, 2019
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 8.1 years ago

Interventions

Clindamycin 1% Geldrug

Topical gel

Placebodrug

Topical Placebo gel