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

Purpose

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	Intervention
Acne Vulgaris	Drug: 1% Clindamycin/5% Benzoyl Peroxide Topical Gel Drug: Placebo


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (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

Resource links provided by NLM:

MedlinePlus related topics: Acne

Drug Information available for: Benzoyl peroxide Clindamycin Clindamycin hydrochloride Clindamycin phosphate Clindamycin palmitate hydrochloride Clindamycin palmitate

U.S. FDA Resources

Further study details as provided by Perrigo Company:

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).


Enrollment:	602
Study Start Date:	December 2007
Study Completion Date:	September 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided

More Information


Responsible Party:	Perrigo Company
ClinicalTrials.gov Identifier:	NCT01044264 History of Changes
Obsolete Identifiers:	NCT00807638
Other Study ID Numbers:	DAC-501-601-727998
Study First Received:	January 4, 2010
Results First Received:	September 14, 2012
Last Updated:	January 17, 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

ClinicalTrials.gov processed this record on July 27, 2017

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