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

Tracking Information

First Received Date ^ICMJE

January 11, 2007

Last Updated Date

September 10, 2007

Start Date ^ICMJE

June 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Success rate on the Investigator's Global Assessment
Change in inflammatory lesion counts
Change in noninflammatory lesion counts

Original Primary Outcome Measures ^ICMJE

Success rate on the Investigator’s Global Assessment
Change in inflammatory lesion counts
Change in noninflammatory lesion counts

Change History

Complete list of historical versions of study NCT00422240 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Percent change in lesion counts (inflammatory, noninflammatory, total)
Change in Investigator’s Global Assessment (IGA)
Subject’s assessment of acne

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Acne Vulgaris

Intervention ^ICMJE

Drug: Adapalene/Benzoyl Peroxide

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

1656

Completion Date

July 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

12 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00422240

Responsible Party

Study ID Numbers ^ICMJE

RD.06.SPR.18087

Study Sponsor ^ICMJE

Galderma

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Michael Graeber, MD

Galderma

Information Provided By

Galderma

Verification Date

September 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP