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

Status:	Completed
Conditions:	Acne, Acne, Dermatology
Therapuetic Areas:	Dermatology / Plastic Surgery
Healthy:	No
Age Range:	12 - 40
Updated:	4/21/2016
Start Date:	April 2015
End Date:	December 2015

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study to Evaluate the Therapeutic Equivalence of a Generic Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel (Glenmark Generics, Ltd) to the Marketed Product BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5% (Valeant Pharmaceuticals, US) in the Treatment of Acne Vulgaris.

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.

Inclusion Criteria:

1. Male or non-pregnant, non-lactating female, ≥12 and ≤40 years of age with a clinical
diagnosis of acne vulgaris.

2. 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:

1. Subject has more than 2 facial nodular lesions; any nodules present will be
documented but not included in the inflammatory lesion count for analysis.

2. Subject has active cystic acne.

3. Subject has acne conglobata.

4. Subjects with excessive facial hair such as beards, sideburns, moustaches, etc. that
would interfere with the diagnosis or assessment of acne.

We found this trial at

sites

Glenmark Investigational Site 10

Belize City, Florida

from

Belize City, FL