Acne Vulgaris Clinical Trial
Official title:
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
| Verified date | May 2018 |
| Source | Akorn, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 1125 |
| Est. completion date | April 22, 2019 |
| Est. primary completion date | April 22, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 12 Years to 40 Years |
| Eligibility |
IInclusion Criteria: - Male or non-pregnant, non-lactating female, =12 and =40 years of age with a clinical diagnosis of acne vulgaris. - Have facial acne with: =20 facial inflammatory lesions (papules and pustules) and =25 non-inflammatory lesions (open and closed comedones), and =2 nodulocystic lesions (nodules and cysts) and have an IGA score of 2, 3 or 4. Exclusion Criteria: - Subject has more than 2 facial nodular lesions; any nodules present will be documented but not included in the inflammatory lesion count for analysis. - Subject has active cystic acne. - Subject has acne conglobata. - Subjects with excessive facial hair such as beards, sideburns, moustaches, etc. that would interfere with the diagnosis or assessment of acne. |
| Country | Name | City | State |
|---|---|---|---|
| Belize | Site 6 | Belize City | |
| Belize | Site 7 | Belize City | |
| United States | Site 1 | Brandon | Florida |
| United States | Site 8 | El Paso | Texas |
| United States | Site 9 | El Paso | Texas |
| United States | Site 11 | Encino | California |
| United States | Site 12 | High Point | North Carolina |
| United States | Site 4 | Miramar | Florida |
| United States | Site 5 | Miramar | Florida |
| United States | Site 10 | Sherman Oaks | California |
| United States | Site 2 | Tampa | Florida |
| United States | Site 3 | Tampa | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Akorn, Inc. |
United States, Belize,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percent Change in the Number of Inflamed Lesions (Papules/Pustules)- Time Frame: Baseline to 12 Weeks | Percent change from baseline to 12 weeks | ||
| Primary | Percent Change in the Non-inflammatory (Open and Closed Comedones) Lesion Counts - Change in Baseline to 12 Week | Percent change in baseline to 12 weeks |
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