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

Taro Pharmaceuticals USA0 sites650 target enrollmentSeptember 2012

ConditionsAcne Vulgaris

InterventionsClindamycin 1%/Benzoyl Peroxide 5% Topical Gel Duac® Topical Gel Placebo Topical Gel

DrugsClindamycin 1%/Benzoyl Peroxide 5% Topical Gel Duac® Topical Gel Placebo Topical Gel

Overview

Phase: Phase 1
Intervention: Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel
Conditions: Acne Vulgaris
Sponsor: Taro Pharmaceuticals USA
Enrollment: 650
Primary Endpoint: Bioequivalence of test gel to reference gel
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

September 2012

End Date

August 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Taro Pharmaceuticals USA

Responsible Party

Sponsor

Eligibility Criteria

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
•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.