A Study Comparing Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel to Duac® Topical Gel in the Treatment of Acne Vulgaris



Status:Completed
Conditions:Acne, Acne, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:12 - 40
Updated:11/30/2013
Start Date:October 2012
End Date:October 2013
Contact:Taro Pharmaceuticals
Phone:914-345-9001

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A Randomized, Double-Blind, Multiple-Site, Placebo-Controlled, Parallel Design Study Comparing Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel (Taro Pharmaceuticals Inc.) to Duac® Topical Gel Clindamycin 1%/Benzoyl Peroxide 5% (Stiefel) in the Treatment of Acne Vulgaris


The objective of this study is to compare the relative efficacy and safety of the test
formulation Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel (Taro Pharmaceuticals Inc.) to
the marketed formulation Duac® Topical Gel (Clindamycin 1%/Benzoyl Peroxide 5%) (Stiefel) in
the treatment of the inflamed lesions of acne vulgaris. Both the test and reference
formulations will also be compared to a placebo formulation to test for superiority.


Inclusion Criteria:

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

- Signed informed consent form. For a minor, the parent or legal guardian will sign the
consent form and patient will sign assent to participate form.

- If female of child-bearing potential, prepare to abstain from sexual intercourse or
use a reliable method of contraception during the study. Patients on hormonal
contraceptives must have been on the same for three months prior to baseline visit
and continue throughout the duration of the study.

- Have facial acne with 20 or more facial inflammatory lesions and 25 or more
non-inflammatory lesions and 2 or less nodulocystic lesions and have an Investigator
Global Assessment score of 2, 3 or 4.

- Willing to comply with the study requirements and restrictions including refraining
from the use of all other topical acne medications or antibiotics during the
treatment period.

Exclusion Criteria:

- Patient has more than 2 facial nodular lesions.

- Patient has active cystic acne.

- Patient has acne conglobata.

- Patients with excessive facial hair that would interfere with the diagnosis or
assessment of acne.

- Patients with tatoos or excessive facial scarring that may interfere with the
evaluation of the patient's acne.

- Patients with active facial sunburn, peeling due to sunburn and patients who will be
exposed to excessive sunlight during the study.

- Any skin condition other than acne vulgaris that would interfere with the evaluation
of the patient's acne.

- Females who are pregnant, lactating or likely to become pregnant during the study.

- Patients with a history of or active colitis other than irritable bowel syndrome.

- History of allergy or hypersensitivity to Clindamycin, Lincomycin or benzoyl peroxide
or history of any drug hypersensitivity or intolerance which would compromise the
patient's safety or the study.

- Significant history or current evidence of chronic infectious disease, system
disorder, organ disorder or other medical condition that would place the patient at
undue risk by participation.

- Use on the face within 1 month prior to screening/baseline or during the study of the
following: cryodestruction or chemodestruction, dermabrasion, photodynamic therapy,
acne surgery, intralesional steroids, x-ray therapy.

- Use of the following within 1 month prior to screening/baseline: spironolactone,
systemic steroids, systemic antibiotics, systemic treatment for acne vulgaris (other
than oral retinoids which require a 6 month washout), systemic anti-inflammatory
agents.

- Use of oral isotretinoin (Accutane®) or oral retinoids within 6 months, or
therapeutic vitamin A supplements greater than 10,000 units/day.

- Use within 2 weeks prior to screening/baseline of the following: topical steroids,
topical retinoids, topical acne treatments including over-the-counter preparations,
topical anti-inflammatory agents, medicated cleansers, topical antibiotics.

- Receipt of any drug as part of a research study within 30 days.

- Female patients taking hormonal contraceptives or oral estrogen for less than 3
months and those that plan to change the dosage regimen during the course of the
study.

- Previous participation in this study.

- Employees of the investigator or research center or their immediate family members.
We found this trial at
22
sites
Denver, Colorado 80211
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Albuquerque, New Mexico 87106
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Albuquerque, NM
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Arlington Heights, Illinois 60005
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Chattanooga, Tennessee 37421
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Chattanooga, TN
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Denver, Colorado 80220
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Fremont, California 94538
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Fremont, CA
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Hazleton, Pennsylvania 18201
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Hazleton, PA
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Henderson, NV
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High Point, North Carolina 27262
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High Point, NC
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Hot Springs, Arkansas 71913
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Hot Springs, AR
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Jacksonville, Florida 32204
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Jacksonville, FL
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Knoxville, Tennessee 37917
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Lauderdale Lakes, Florida 33319
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Long Beach, California 90804
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Long Beach, CA
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Miami, FL
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Nashville, Tennessee 37215
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Phoenix, Arizona 85018
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Pittsburgh, Pennsylvania 15206
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Plainfield, Indiana 46168
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Salisbury, North Carolina 28144
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Salisbury, NC
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Santa Clara, CA
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St. Petersburg, Florida 33716
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St. Petersburg, FL
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