ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00422240
Recruitment Status : Completed
First Posted : January 15, 2007
Last Update Posted : September 11, 2007
Sponsor:
Information provided by:
Galderma

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

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

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, Learn About Clinical Studies.


Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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

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


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

Additional Information:
Publications:
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
First Posted: January 15, 2007    Key Record Dates
Last Update Posted: September 11, 2007
Last Verified: September 2007

Keywords provided by Galderma:
Acne vulgaris
Adapalene
Benzoyl Peroxide

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Benzoyl Peroxide
Adapalene
Adapalene, Benzoyl Peroxide Drug Combination
Dermatologic Agents
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