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

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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
15
sites
Greenville, South Carolina
2019
mi
from 91732
Greenville, SC
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Anaheim, California
17
mi
from 91732
Anaheim, CA
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Belize City, Florida
2197
mi
from 91732
Belize City, FL
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Belize City, Florida
2197
mi
from 91732
Belize City, FL
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2146
mi
from 91732
Brandon, FL
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Long Beach, California
23
mi
from 91732
Long Beach, CA
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Los Angeles, California
13
mi
from 91732
Los Angeles, CA
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Louisville, Kentucky
1812
mi
from 91732
Louisville, KY
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2322
mi
from 91732
Miami, FL
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2322
mi
from 91732
Miami, FL
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2313
mi
from 91732
Miramar, FL
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Nashville, Tennessee
1763
mi
from 91732
Nashville, TN
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St. Petersburg, Florida
2131
mi
from 91732
St. Petersburg, FL
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Upper St. Clair, Pennsylvania
2114
mi
from 91732
Upper St. Clair, PA
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West Covina, California
4
mi
from 91732
West Covina, CA
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