Clinical Study Between Two 1% Clindamycin/5% Benzoyl Peroxide Topical Gel Formulations

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Perrigo Company

ClinicalTrials.gov Identifier:

NCT01044264

First received: January 4, 2010

Last updated: January 17, 2013

Last verified: January 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	January 4, 2010
Last Updated Date	January 17, 2013
Start Date ^ICMJE	December 2007
Primary Completion Date	September 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 17, 2013)	Reduction of Inflammatory Lesions [ Time Frame: Baseline and week 11 ] [ Designated as safety issue: No ] The primary endpoint of the study was the mean percent reduction from baseline to week 11 in inflamed lesion count (papules and pustules).
Original Primary Outcome Measures ^ICMJE (submitted: January 5, 2010)	Percent reduction from baseline in inflamed lesion count [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT01044264 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Clinical Study Between Two 1% Clindamycin/5% Benzoyl Peroxide Topical Gel Formulations
Official Title ^ICMJE	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
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Acne Vulgaris
Intervention ^ICMJE	Drug: 1% Clindamycin/5% Benzoyl Peroxide Topical Gel Topical Gel Other Name: DUAC® 1% Clindamycin/5% Benzoyl Peroxide Topical Gel Drug: Placebo Placebo
Study Arm (s)	Active Comparator: 1% Clindamycin/5% Benzoyl Peroxide Topical Gel Test product Intervention: Drug: 1% Clindamycin/5% Benzoyl Peroxide Topical Gel Active Comparator: DUAC® 1% Clindamycin/5% Benzoyl Peroxide Topical Gel Reference product Intervention: Drug: 1% Clindamycin/5% Benzoyl Peroxide Topical Gel Placebo Comparator: Placebo Intervention: Drug: Placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	602
Completion Date	September 2008
Primary Completion Date	September 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	12 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01044264
Other Study ID Numbers ^ICMJE	DAC-501-601-727998
Has Data Monitoring Committee	Yes
Responsible Party	Perrigo Company
Study Sponsor ^ICMJE	Perrigo Company
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Perrigo Company
Verification Date	January 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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