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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01138514
Recruitment Status : Completed
First Posted : June 7, 2010
Results First Posted : March 29, 2016
Last Update Posted : March 29, 2016
Information provided by (Responsible Party):
Perrigo Company

Brief Summary:
The purpose of this study is to compare the efficacy and safety profiles of Perrigo Israel Pharmaceuticals, Ltd. Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel and Benzaclin® Topical Gel (Clindamycin- Benzoyl Peroxide Gel).

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo) Drug: Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin) Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1555 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study to Compare Perrigo Israel Pharmaceuticals, Ltd., Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel to a Comparator Clindamycin / Benzoyl Peroxide Topical Gel, and Both Active Treatments to a Vehicle Control in the Treatment of Acne Vulgaris
Study Start Date : October 2009
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Arm Intervention/treatment
Active Comparator: Clindamycin 1%/Benzoyl Peroxide 5% Drug: Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo)
Applied to the entire face twice daily for 10 weeks

Active Comparator: Reference Product Drug: Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin)
Applied to the entire face twice daily for 10 weeks

Placebo Comparator: Vehicle Drug: Placebo

Primary Outcome Measures :
  1. Percent Change From Baseline in Inflammatory Lesions [ Time Frame: 10 weeks ]
  2. Percent Change From Baseline in Non-inflammatory Lesions [ Time Frame: 10 weeks ]

Secondary Outcome Measures :
  1. Number of Participant With Clinical Success on the Investigator's Global Assessment (IGA) [ Time Frame: 10 weeks ]
    Clinical success was defined as a score of clear (0) or almost clear (1) at Week 10.

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Healthy men or women, 12 to 65 years of age
  • Willing to participate and sign provide written consent
  • Moderate to severe acne

Exclusion Criteria:

  • Pregnant or lactating women
  • History of unresponsiveness or hypersensitivity to clindamycin, benzoyl peroxide or lincomycin
  • Use of systemic, topical or facial products which may interfere with the study
  • Participation in any clinical study in the 30 days prior to study entry
  • Prolonged exposure to sunlight or excessive exposure to UV lights
  • Chronic use of NSAIDS

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Responsible Party: Perrigo Company Identifier: NCT01138514    
Other Study ID Numbers: PRG-716
First Posted: June 7, 2010    Key Record Dates
Results First Posted: March 29, 2016
Last Update Posted: March 29, 2016
Last Verified: March 2016
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Clindamycin palmitate
Clindamycin phosphate
Benzoyl Peroxide
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Dermatologic Agents