Clinical trial

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

Name

RD.06.SPR.18087

Description

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.

Trial arms

Trial start

2006-06-27

Estimated PCD

2007-07-12

Trial end

2007-07-12

Status

Completed

Phase

Early phase I

Treatment

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.

Arms:

Adapalene/Benzoyl Peroxide Gel

Adapalene Gel, 0.1%

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

Arms:

Adapalene Gel, 0.1%

Benzoyl Peroxide Gel 2.5%

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

Arms:

Benzoyl Peroxide Gel 2.5%

Gel Vehicle

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

Arms:

Gel Vehicle

Size

1668

Primary endpoint

Percentage of Participants Who Achieved Success Rate 0 (Clear) or 1 (Almost Clear) on the Investigator Global Assessment (IGA) Scale at Week 12 (Last Observation Carried Forward)

At Week 12

Change in Inflammatory Lesion Count From Baseline to Week 12

Baseline to Week 12

Change in Noninflammatory Lesion Count From Baseline to Week 12

Baseline to Week 12

Eligibility 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 1668, 'type': 'ACTUAL'}}

Updated at

2024-04-15

1 organization

4 products

1 indication

Organization

Galderma R&D

Product

Adapalene + Benzoyl Peroxide

Indication

Product

Product

Product