Bioequivalence Study of Clindamycin Gel 1% in Treatment of Acne Vulgaris
- Registration Number
- NCT03522441
- Lead Sponsor
- Akorn, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1125
Inclusion 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Clindamycin 1% gel (Akorn Pharmaceuticals) Clindamycin 1% Gel - Clindamycin 1% gel (Greenstone LLC) Clindamycin 1% Gel - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Percent Change in the Number of Inflamed Lesions (Papules/Pustules)- Time Frame: Baseline to 12 Weeks Percent change from baseline to 12 weeks 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (12)
Site 1
🇺🇸Brandon, Florida, United States
Site 11
🇺🇸Encino, California, United States
Site 4
🇺🇸Miramar, Florida, United States
Site 10
🇺🇸Sherman Oaks, California, United States
Site 5
🇺🇸Miramar, Florida, United States
Site 3
🇺🇸Tampa, Florida, United States
Site 2
🇺🇸Tampa, Florida, United States
Site 12
🇺🇸High Point, North Carolina, United States
Site 9
🇺🇸El Paso, Texas, United States
Site 8
🇺🇸El Paso, Texas, United States
Site 6
🇧🇿Belize City, Belize
Site 7
🇧🇿Belize City, Belize