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

Phase 3CompletedNCT00421993

Galderma R&D1,670 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

1,670

Conditions

Acne Vulgaris

Interventions

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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. Exclusion Criteria: * More than one acne nodule or any acne cyst. * Acne conglobata, acne fulminans, secondary acne, or severe acne. * Known previous participation in an Adapalene/Benzoyl Peroxide Topical Gel Trial. * Underlying diseases that require the use of interfering topical or systemic therapy. * Use of prohibited medications prior to the study unless appropriate washout period is documented * Use of hormonal contraceptives solely for control of acne

Locations (62)

Medical Affliated Research Center

Huntsville, Alabama, United States

Dermatology Research of Arkansas

Little Rock, Arkansas, United States

Associates in research, Inc.

Fresno, California, United States

University of California, Irvine

Irvine, California, United States

Dermatology Research Associates

Los Angeles, California, United States

Outcomes

Primary Outcomes

Success Rate on the Investigator's Global Assessment

Percentage of subjects rated "Clear" and "Almost Clear" on 5-point scale (0=clear; 4=severe)

Time frame: at week 12

Changes in Inflammatory Lesion Counts

Changes in Inflammatory Lesion Counts equals Week 12 Inflammatory Lesion Counts minus Baseline Inflammatory Lesion Counts

Time frame: from Baseline to week 12

Changes in Noninflammatory Lesion Counts

Change in Noninflammatory Lesion Counts equals Week 12 Noninflammatory Lesion Count minus Baseline Noninflammatory Lesion Count

Time frame: from Baseline to week 12

Secondary Outcomes

Percent Change in Inflammatory Lesion Counts

Percent Changes in Inflammatory Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100

Time frame: at week 12

Percent Change in Noniflammatory Lesion Counts

Percent Changes in Noninflammatory Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100

Time frame: at week 12

Percent Change in Total Lesion Counts

Percent Changes in Total Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100

Time frame: at week 12