Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With Acne Vulgaris

This study has been completed.
Sponsor:
Information provided by:
Galderma
ClinicalTrials.gov Identifier:
NCT00422240
First received: January 11, 2007
Last updated: September 10, 2007
Last verified: September 2007
  Purpose

This is a multi-center, randomized, double-blind, parallel group study with 12 weeks of treatment of acne vulgaris. Efficacy and safety evaluations will be performed at Screening (safety only), Baseline and Weeks 1, 2, 4, 8 and 12. All Investigator's Global Assessment evaluators and lesion counters must be trained and approved by Galderma. The evaluator of a subject should remain the same during the study.

The primary objective is to demonstrate the superiority in efficacy and assess safety of adapalene/benzoyl peroxide topical gel (adapalene/benzoyl peroxide gel) versus adapalene topical gel, 0.1% (adapalene monad); benzoyl peroxide topical gel, 2.5% (benzoyl peroxide monad) and topical gel vehicle (gel vehicle) in the treatment of acne vulgaris for up to 12 weeks.


Condition Intervention Phase
Acne Vulgaris
Drug: Adapalene/Benzoyl Peroxide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Multi-Center, Randomized, Double-Blind, Parallel-Group Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel Compared With Adapalene Topical Gel, 0.1%; Benzoyl Peroxide Topical Gel, 2.5% and Topical Gel Vehicle in Subjects With Acne Vulgaris

Resource links provided by NLM:


Further study details as provided by Galderma:

Primary Outcome Measures:
  • Success rate on the Investigator's Global Assessment
  • Change in inflammatory lesion counts
  • Change in noninflammatory lesion counts

Secondary Outcome Measures:
  • Percent change in lesion counts (inflammatory, noninflammatory, total)
  • Change in Investigator's Global Assessment (IGA)
  • Subject's assessment of acne

Estimated Enrollment: 1656
Study Start Date: June 2006
Study Completion Date: July 2007
  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A clinical diagnosis of acne vulgaris with facial involvement.
  • A minimum of 20 but not more than 50 inflammatory lesions
  • A minimum of 30 but not more than 100 noninflammatory lesions
  • A score of 3 (Moderate) on the Investigator's Global Assessment Scale
  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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00422240

Locations
United States, Texas
Miller MD
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Galderma
Investigators
Study Director: Michael Graeber, MD Galderma
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00422240     History of Changes
Other Study ID Numbers: RD.06.SPR.18087
Study First Received: January 11, 2007
Last Updated: September 10, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Galderma:
Acne vulgaris
Adapalene
Benzoyl Peroxide

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Adapalene
Benzoyl Peroxide
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 20, 2014