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
  Purpose

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

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

Resource links provided by NLM:


Further study details as provided by Perrigo Company:

Primary Outcome Measures:
  • 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).


Enrollment: 602
Study Start Date: December 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
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
  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

No publications provided

Responsible Party: Perrigo Company
ClinicalTrials.gov Identifier: NCT01044264     History of Changes
Obsolete Identifiers: NCT00807638
Other Study ID Numbers: DAC-501-601-727998
Study First Received: January 4, 2010
Results First Received: September 14, 2012
Last Updated: January 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Perrigo Company:
Acne Vulgaris
bioequivalency
clindamycin
benzoyl peroxide

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 July 29, 2014