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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Perrigo Company
ClinicalTrials.gov Identifier:
NCT01138514
First received: June 4, 2010
Last updated: June 19, 2012
Last verified: June 2012
  Purpose

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:
  • Mean percent change from baseline in both inflammatory and non-inflammatory lesions [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]

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
Placebo

  Eligibility

Ages Eligible for Study:   12 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Perrigo Company
ClinicalTrials.gov Identifier: NCT01138514     History of Changes
Other Study ID Numbers: PRG-716
Study First Received: June 4, 2010
Last Updated: June 19, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Benzoyl Peroxide
Clindamycin
Clindamycin-2-phosphate
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on April 14, 2014