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

Galderma

Status and phase

Completed

Phase 3

Conditions

Acne Vulgaris

Treatments

Drug: Adapalene Gel, 0.1%

Drug: Gel Vehicle

Drug: Benzoyl Peroxide Gel 2.5%

Drug: Adapalene/Benzoyl Peroxide

Study type

Interventional

Funder types

Industry

Identifiers

NCT00422240

RD.06.SPR.18087

Details and patient eligibility

About

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.

Enrollment

1,668 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

1,668 participants in 4 patient groups, including a placebo group

Adapalene/Benzoyl Peroxide Gel

Experimental group

Description:

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.

Treatment:

Drug: Adapalene/Benzoyl Peroxide

Adapalene Gel, 0.1%

Experimental group

Description:

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

Treatment:

Drug: Adapalene Gel, 0.1%

Benzoyl Peroxide Gel 2.5%

Experimental group

Description:

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