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

This study has been completed.
Information provided by (Responsible Party):
Perrigo Company Identifier:
First received: June 4, 2010
Last updated: March 28, 2016
Last verified: March 2016
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 Intervention Phase
Acne Vulgaris
Drug: Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo)
Drug: Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

Further study details as provided by Perrigo Company:

Primary Outcome Measures:
  • Percent Change From Baseline in Inflammatory Lesions [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Non-inflammatory Lesions [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Participant With Clinical Success on the Investigator's Global Assessment (IGA) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    Clinical success was defined as a score of clear (0) or almost clear (1) at Week 10.

Enrollment: 1555
Study Start Date: October 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   12 Years to 65 Years   (Child, Adult)
Genders Eligible for Study:   Both
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
  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 Identifier: NCT01138514     History of Changes
Other Study ID Numbers: PRG-716 
Study First Received: June 4, 2010
Results First Received: January 5, 2016
Last Updated: March 28, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
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 processed this record on October 21, 2016