To Study Generic Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel (Glenmark Generics, Ltd) in the Treatment of Acne Vulgaris.

Completed · Phase 3 · Has a placebo group

Conditions studied: Acne Vulgaris

In brief

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.

Key facts

Study ID

NCT02465632

Run by

Glenmark Pharmaceuticals Ltd. India

People needed

1100

Starts

2015-04-01

Expected to finish

2015-12-01

Last updated by the study team

2017-06-28

Who can join

Age: 12 and older, up to 40. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Glenmark Investigational Site 13 — Anaheim, California, United States
• Glenmark Investigational Site 6 — Long Beach, California, United States
• Glenmark Investigational Site 15 — Los Angeles, California, United States
• Glenmark Investigational Site12 — West Covina, California, United States
• Glenmark Investigational Site 4 — Brandon, Florida, United States
• Glenmark Investigational Site 1 — Miami, Florida, United States
• Glenmark Investigational Site 8 — Miami, Florida, United States
• Glenmark Investigational Site 9 — Miramar, Florida, United States
• Glenmark Investigational Site 2 — St. Petersburg, Florida, United States
• Glenmark Investigational Site 5 — Louisville, Kentucky, United States
• Glenmark Investigational Site7 — Upper Saint Clair, Pennsylvania, United States
• Glenmark Investigational Site 14 — Greenville, South Carolina, United States
• Glenmark Investigational Site 3 — Nashville, Tennessee, United States
• Glenmark Investigational Site 10 — Belize City, Belize
• Glenmark Investigational Site 11 — Belize City, Belize

Full record on ClinicalTrials.gov

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