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

January 4, 2010
January 17, 2013
December 2007
September 2008   (final data collection date for primary outcome measure)
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).
Percent reduction from baseline in inflamed lesion count [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01044264 on ClinicalTrials.gov Archive Site
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Clinical Study Between Two 1% Clindamycin/5% Benzoyl Peroxide Topical Gel Formulations
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

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.

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Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Acne Vulgaris
  • Drug: 1% Clindamycin/5% Benzoyl Peroxide Topical Gel
    Topical Gel
    Other Name: DUAC® 1% Clindamycin/5% Benzoyl Peroxide Topical Gel
  • Drug: Placebo
    Placebo
  • 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
602
September 2008
September 2008   (final data collection date for primary outcome measure)

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
Both
12 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01044264
DAC-501-601-727998
Yes
Perrigo Company
Perrigo Company
Not Provided
Not Provided
Perrigo Company
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP