To Study Generic Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel (Glenmark Generics, Ltd) in the Treatment of Acne Vulgaris.
- Conditions
- Acne Vulgaris
- Interventions
- Registration Number
- NCT02465632
- Lead Sponsor
- Glenmark Pharmaceuticals Ltd. India
- 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%/ Benzoyl peroxide 5% topical gel (Glenmark Generics, Ltd), and the marketed product BenzaClin® Topical Gel, Clindamycin 1%/ Benzoyl peroxide 5% (Valeant Pharmaceuticals, US) in the treatment of acne vulgaris.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1100
- 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.
- 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 BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5% BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5% apply a thin layer of the gel to the face Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel apply a thin layer of gel to the face Placebo topical gel Placebo apply a thin layer of the gel to the face
- Primary Outcome Measures
Name Time Method Mean Percent Change in the Number of Inflamed Lesions (Papules/Pustules) Baseline and 10 Weeks The number of inflammatory lesions (papules and pustules) count between the treatment groups were estimated.
Mean Percent Change in the Number of Non-inflamed Lesions (Open and Closed Comedones) Baseline and 10 Weeks The number of non-inflamed lesions (open and closed comedones) count between treatment groups were estimated.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (15)
Glenmark Investigational Site 13
🇺🇸Anaheim, California, United States
Glenmark Investigational Site 6
🇺🇸Long Beach, California, United States
Glenmark Investigational Site12
🇺🇸West Covina, California, United States
Glenmark Investigational Site 4
🇺🇸Brandon, Florida, United States
Glenmark Investigational Site 10
🇧🇿Belize City, Belize
Glenmark Investigational Site 1
🇺🇸Miami, Florida, United States
Glenmark Investigational Site 11
🇧🇿Belize City, Belize
Glenmark Investigational Site 8
🇺🇸Miami, Florida, United States
Glenmark Investigational Site 3
🇺🇸Nashville, Tennessee, United States
Glenmark Investigational Site 2
🇺🇸Saint Petersburg, Florida, United States
Glenmark Investigational Site 9
🇺🇸Miramar, Florida, United States
Glenmark Investigational Site 5
🇺🇸Louisville, Kentucky, United States
Glenmark Investigational Site7
🇺🇸Upper Saint Clair, Pennsylvania, United States
Glenmark Investigational Site 15
🇺🇸Los Angeles, California, United States
Glenmark Investigational Site 14
🇺🇸Greenville, South Carolina, United States