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

October 27, 2023 updated by: Galderma R&D

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1668

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78229
        • Miller MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Experimental: Adapalene Gel, 0.1%
Participants were treated with 0.1% of adapalene 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.
Experimental: Benzoyl Peroxide Gel 2.5%
Participants were treated with 2.5% of benzoyl peroxide 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.
Placebo Comparator: Gel Vehicle
Participants were treated with gel vehicle 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Time Frame: At Week 12
Success rate was defined as percentage of participants who achieved "Clear" or "Almost Clear" score on the IGA scale. IGA scale consisted of 5 grades (0-4) among which 0 = Clear (Minor, residual discoloration, no erythema or induration/papulation, no oozing/crusting), 1 = Almost clear (Trace, faint pink erythema with almost no induration/papulation and no oozing/crusting), 2 = Mild (Faint pink erythema with mild induration/papulation and no oozing/crusting), 3 = Moderate (Pink-red erythema with moderate induration/papulation and there may be some oozing/crusting.), 4 = Severe (Deep/bright red erythema with severe induration/papulation with oozing/crusting). All missing values were imputed by LOCF.
At Week 12
Change in Inflammatory Lesion Count From Baseline to Week 12
Time Frame: Baseline to Week 12
Change in inflammatory lesion count from baseline to week 12 was reported. All missing values were imputed by LOCF.
Baseline to Week 12
Change in Noninflammatory Lesion Count From Baseline to Week 12
Time Frame: Baseline to Week 12
Change in noninflammatory lesion count from baseline to week 12 was reported. All missing values were imputed by LOCF.
Baseline to Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in Inflammatory Lesion Counts at Week 12
Time Frame: Baseline, Week 12
The Inflammatory Lesion Count was the sum of papules and pustules. Percent change from Baseline was calculated as the values at Week 12 minus the value at Baseline divided by Baseline value * 100. All missing values were imputed by LOCF.
Baseline, Week 12
Percent Change From Baseline in Noninflammatory Lesion Counts at Week 12
Time Frame: Baseline, Week 12
The Noninflammatory Lesion Count was the sum of open comedones and closed comedones. Percent change from Baseline was calculated as the values at Week 12 minus the value at Baseline divided by Baseline value * 100. All missing values were imputed by LOCF.
Baseline, Week 12
Percent Change From Baseline in Total Lesion Counts at Week 12
Time Frame: Baseline, Week 12
The Total Lesion Count was the sum of Inflammatory, Noninflammatory Lesion Counts, Nodules and Cysts.
Baseline, Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Galderma R&D

Investigators

  • Study Director: Michael Graeber, MD, Galderma R&D

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 27, 2006

Primary Completion (Actual)

July 12, 2007

Study Completion (Actual)

July 12, 2007

Study Registration Dates

First Submitted

January 11, 2007

First Submitted That Met QC Criteria

January 11, 2007

First Posted (Estimated)

January 15, 2007

Study Record Updates

Last Update Posted (Actual)

April 15, 2024

Last Update Submitted That Met QC Criteria

October 27, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RD.06.SPR.18087

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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