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

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ClinicalTrials.gov Identifier: NCT00422240
Recruitment Status : Completed
First Posted : January 15, 2007
Last Update Posted : February 18, 2021
Information provided by:
Galderma R&D

Brief Summary:

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 or disease Intervention/treatment Phase
Acne Vulgaris Drug: Adapalene/Benzoyl Peroxide Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1656 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : June 2006
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Primary Outcome Measures :
  1. Success rate on the Investigator's Global Assessment
  2. Change in inflammatory lesion counts
  3. Change in noninflammatory lesion counts

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

Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00422240

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United States, Texas
Miller MD
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Galderma R&D
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Study Director: Michael Graeber, MD Galderma R&D
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00422240    
Other Study ID Numbers: RD.06.SPR.18087
First Posted: January 15, 2007    Key Record Dates
Last Update Posted: February 18, 2021
Last Verified: September 2007
Keywords provided by Galderma R&D:
Acne vulgaris
Benzoyl Peroxide
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Adapalene, Benzoyl Peroxide Drug Combination
Benzoyl Peroxide
Dermatologic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents