A Phase 1 interventional study of Clindamycin and Benzoyl Peroxide Gel 1%5% and BenzaClin® Topical Gel in Acne Vulgaris, sponsored by Taro Pharmaceuticals USA. Completed. Open to participants aged 12 Years to 40 Years. Per ClinicalTrials.gov, last updated 2017-05-04.
Sponsored by Taro Pharmaceuticals USA · Phase 1, Interventional, and Treatment
This study is to evaluate the therapeutic equivalence and safety of Clindamycin and Benzoyl Peroxide Gel 1%/5% and BenzaClin® (clindamycin 1%/benzoyl peroxide 5%) Topical Gel
The objectives of this study are to evaluate the therapeutic equivalence and safety of Clindamycin and Benzoyl Peroxide Gel 1%/5% (Taro Pharmaceuticals Inc.) and BenzaClin® (clindamycin 1%/benzoyl peroxide 5%) Topical Gel (Sanofi Aventis, US) in the treatment of acne vulgaris and to demonstrate the superiority of the efficacy of the test and reference products over the placebo control
730 studies on the registry are indexed under Acne Vulgaris; 85 are open to participants now.
This study's enrollment of 1,000 is above the median of 68 across 627 interventional studies indexed under Acne Vulgaris.
Browse Acne Vulgaris studies →Taro Pharmaceuticals USA is the lead sponsor of 71 studies on the registry; none are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 1 (5%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria
Clindamycin and Benzoyl Peroxide Gel 1%/5% applied twice daily (morning and evening) for 70 days (10 weeks).
Drug: Clindamycin and Benzoyl Peroxide Gel 1%5%
BenzaClin® (clindamycin 1%/benzoyl peroxide 5%) Topical Gel applied twice daily (morning and evening) for 70 days (10 weeks).
Drug: BenzaClin® Topical Gel
Placebo (vehicle of the test product) applied twice daily (morning and evening) for 70 days (10 weeks).
Drug: Placebo
Clindamycin and Benzoyl Peroxide Gel 1%5% (Taro Pharmaceuticals Inc.)
Also known as: Active
BenzaClin® (clindamycin 1%/benzoyl peroxide 5%) Topical Gel (Sanofi Aventis, U.S.)
Also known as: Active
Placebo (vehicle of the test product) (Taro Pharmaceuticals Inc.)
Also known as: Vehicle
Change in inflammatory lesion count
Mean percent change from baseline to week 10 (study day 70) in the inflammatory (papules and pustules) lesion counts.
Time frame: Week 10 (day 70)
Change in non-inflammatory lesion count
Mean percent change from baseline to week 10 (study day 70) in the non-inflammatory (open and closed comedones) lesion counts.
Time frame: Week 10 (day 70)
Clinical response of success
The proportion of subjects with a clinical response of success at week 10 (study day 70) defined as an Investigator's Global Assessment score at least 2 grades less than baseline assessment.
Time frame: Week 10 (day 70)
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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Taro Pharmaceuticals USA