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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1668 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-27

Study Completion Date

2007-07-12

Brief Summary

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This was a multi-center, randomized, double-blind, parallel group study with 12 weeks of treatment of acne vulgaris. Efficacy and safety evaluations were 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 participant should remain the same during the study.

The primary objective was 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.

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Detailed Description

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Conditions

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Acne Vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Adapalene/Benzoyl Peroxide Gel

Participants were treated with adapalene 0.1 % \[weight by weight (W/W)\]/benzoyl peroxide 2.5 % (W/W) gel topically daily in the evening for 12 Weeks.

Group Type EXPERIMENTAL

Adapalene/Benzoyl Peroxide

Intervention Type DRUG

Adapalene 0.1 % \[weight by weight (W/W)\]/benzoyl peroxide 2.5 % (W/W) gel topically daily in the evening for 12 Weeks.

Adapalene Gel, 0.1%

Participants were treated with 0.1% of adapalene gel topically daily in the evening for 12 Weeks.

Group Type EXPERIMENTAL

Adapalene Gel, 0.1%

Intervention Type DRUG

0.1% of adapalene gel topically daily in the evening for 12 Weeks.

Benzoyl Peroxide Gel 2.5%

Participants were treated with 2.5% of benzoyl peroxide gel topically daily in the evening for 12 Weeks.

Group Type EXPERIMENTAL

Benzoyl Peroxide Gel 2.5%

Intervention Type DRUG

2.5% of benzoyl peroxide gel topically daily in the evening for 12 Weeks.

Gel Vehicle

Participants were treated with gel vehicle topically daily in the evening for 12 Weeks.

Group Type PLACEBO_COMPARATOR

Gel Vehicle

Intervention Type DRUG

Participants were treated with gel vehicle topically daily in the evening for 12 Weeks.

Interventions

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Adapalene/Benzoyl Peroxide

Adapalene 0.1 % \[weight by weight (W/W)\]/benzoyl peroxide 2.5 % (W/W) gel topically daily in the evening for 12 Weeks.

Intervention Type DRUG

Adapalene Gel, 0.1%

0.1% of adapalene gel topically daily in the evening for 12 Weeks.

Intervention Type DRUG

Benzoyl Peroxide Gel 2.5%

2.5% of benzoyl peroxide gel topically daily in the evening for 12 Weeks.

Intervention Type DRUG

Gel Vehicle

Participants were treated with gel vehicle topically daily in the evening for 12 Weeks.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No