Trials / Completed
CompletedNCT03522441
Bioequivalence Study of Clindamycin Gel 1% in Treatment of Acne Vulgaris
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,125 (actual)
- Sponsor
- Akorn, Inc. · Industry
- Sex
- All
- Age
- 12 Years – 40 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Clindamycin 1% Gel | Topical gel |
| DRUG | Placebo | Topical Placebo gel |
Timeline
- Start date
- 2018-04-27
- Primary completion
- 2019-04-22
- Completion
- 2019-04-22
- First posted
- 2018-05-11
- Last updated
- 2020-10-05
- Results posted
- 2020-10-05
Locations
12 sites across 2 countries: United States, Belize
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03522441. Inclusion in this directory is not an endorsement.