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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:
Information provided by (Responsible Party):
Perrigo Company

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

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
Primary Completion Date : September 2008
Study Completion Date : September 2008


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 :
  1. 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).



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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

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