Clinical Study Between Two 1% Clindamycin/5% Benzoyl Peroxide Topical Gel Formulations
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ClinicalTrials.gov Identifier: NCT01044264 |
Recruitment Status
:
Completed
First Posted
: January 7, 2010
Results First Posted
: December 17, 2012
Last Update Posted
: January 24, 2013
|
Sponsor:
Perrigo Company
Information provided by (Responsible Party):
Perrigo Company
- Study Details
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Brief Summary:
A randomized, double-blind, multiple-site, placebo-controlled, parallel-group clinical study conducted to evaluate the bioequivalence of two 1% Clindamycin/5% Benzoyl Peroxide Topical Gel formulations.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acne Vulgaris | Drug: 1% Clindamycin/5% Benzoyl Peroxide Topical Gel Drug: Placebo | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 602 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Double-Blind, Multiple-Site, Placebo-Controlled Study Comparing Two 1% Clindamycin/5% Benzoyl Peroxide Topical Gel Formulations in the Treatment of Moderate to Severe Acne Vulgaris |
Study Start Date : | December 2007 |
Actual Primary Completion Date : | September 2008 |
Actual Study Completion Date : | September 2008 |
Resource links provided by the National Library of Medicine

MedlinePlus related topics:
Acne
Drug Information available for:
Benzoyl peroxide
Clindamycin
Clindamycin hydrochloride
Clindamycin phosphate
Clindamycin palmitate hydrochloride
Clindamycin palmitate
U.S. FDA Resources
Arm | Intervention/treatment |
---|---|
Active Comparator: 1% Clindamycin/5% Benzoyl Peroxide Topical Gel
Test product
|
Drug: 1% Clindamycin/5% Benzoyl Peroxide Topical Gel
Topical Gel
Other Name: DUAC® 1% Clindamycin/5% Benzoyl Peroxide Topical Gel
|
Active Comparator: DUAC® 1% Clindamycin/5% Benzoyl Peroxide Topical Gel
Reference product
|
Drug: 1% Clindamycin/5% Benzoyl Peroxide Topical Gel
Topical Gel
Other Name: DUAC® 1% Clindamycin/5% Benzoyl Peroxide Topical Gel
|
Placebo Comparator: Placebo |
Drug: Placebo
Placebo
|
Primary Outcome Measures
:
- Reduction of Inflammatory Lesions [ Time Frame: Baseline and week 11 ]The primary endpoint of the study was the mean percent reduction from baseline to week 11 in inflamed lesion count (papules and pustules).
Information from the National Library of Medicine

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Ages Eligible for Study: | 12 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- healthy men or women, 12 years of age and older
- willing to participate and sign a copy of the informed consent form
- moderate to severe facial acne
Exclusion Criteria:
- history of allergy or hypersensitivity to clindamycin or benzoyl peroxide
- pregnant or lactating women
- evidence of a clinically significant disorder
- receipt of any drugs as part of a research study within 30 days prior to study dosing
- use of systemic, topical or facial products which may interfere with study
- significant facial hair, tattoos, excessive facial scarring, active facial sunburn, or peeling due to sunburn
No Contacts or Locations Provided
Responsible Party: | Perrigo Company |
ClinicalTrials.gov Identifier: | NCT01044264 History of Changes |
Obsolete Identifiers: | NCT00807638 |
Other Study ID Numbers: |
DAC-501-601-727998 |
First Posted: | January 7, 2010 Key Record Dates |
Results First Posted: | December 17, 2012 |
Last Update Posted: | January 24, 2013 |
Last Verified: | January 2013 |
Keywords provided by Perrigo Company:
Acne Vulgaris bioequivalency clindamycin benzoyl peroxide |
Additional relevant MeSH terms:
Acne Vulgaris Acneiform Eruptions Skin Diseases Sebaceous Gland Diseases Clindamycin Clindamycin palmitate Clindamycin phosphate |
Benzoyl Peroxide Anti-Bacterial Agents Anti-Infective Agents Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Dermatologic Agents |