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

NCT00422240 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1668

Last updated 2024-04-15

Study results available
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Summary

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.

Conditions

  • Acne Vulgaris

Interventions

DRUG

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.

DRUG

Adapalene Gel, 0.1%

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

DRUG

Benzoyl Peroxide Gel 2.5%

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

DRUG

Gel Vehicle

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

Sponsors & Collaborators

  • Galderma R&D

    lead INDUSTRY

Principal Investigators

  • Michael Graeber, MD · Galderma R&D

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-27
Primary Completion
2007-07-12
Completion
2007-07-12

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00422240 on ClinicalTrials.gov