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

Sponsored by:	Galderma
Information provided by:	Galderma
ClinicalTrials.gov Identifier:	NCT00422240

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 III

MedlinePlus related topics: Acne

Drug Information available for: Benzoyl peroxide Adapalene

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

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

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:

Related Info This link exits the ClinicalTrials.gov site

Publications:

Leyden JJ. A review of the use of combination therapies for the treatment of acne vulgaris. J Am Acad Dermatol. 2003 Sep;49(3 Suppl):S200-10. Review.

Study ID Numbers:	RD.06.SPR.18087
Study First Received:	January 11, 2007
Last Updated:	September 10, 2007
ClinicalTrials.gov Identifier:	NCT00422240
Health Authority:	United States: Food and Drug Administration

Keywords provided by Galderma:

Acne vulgaris
Adapalene
Benzoyl Peroxide

Study placed in the following topic categories:

Exanthema
Facial Dermatoses
Facies
Skin Diseases

Benzoyl Peroxide
Adapalene
Sebaceous Gland Diseases
Acne Vulgaris

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Physiological Effects of Drugs
Pharmacologic Actions
Acneiform Eruptions
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses

Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Dermatologic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 12, 2009