Efficacy and Safety of Fixed Combination Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel in the Treatment of Acne Vulgaris

February 16, 2021 updated by: Galderma R&D

Efficacy and Safety of Fixed Combination Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel Compared to Clindamycin 0.1% / Benzoyl Peroxide 5% Gel in the Treatment of Acne Vulgaris

The purpose of this study is to demonstrate the non-inferior efficacy of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel when compared to Clindamycin 1% / Benzoyl Peroxide 5% Gel in Subjects with acne vulgaris after a 12-week treatment period.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

272

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
    • California
      • Santa Monica, California, United States, 90404
        • Paul YAMAUCHI
    • Minnesota
      • Fridley, Minnesota, United States, 55432
        • Steven E. KEMPERS
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Dr Alicia BUCKO
    • New York
      • Rochester, New York, United States, 14609
        • Elisabeth ARTHUR

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

12 years to 35 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Male or female Subjects of any race, between the age of 12 and 35 years inclusive, with acne vulgaris, meeting specific inclusion/exclusion criteria.

Main inclusion criteria:

  1. Male or female Subjects of any race, aged 12 to 35 years inclusive, with facial acne vulgaris,
  2. Subjects with a minimum of 20 inflammatory lesions (papules and pustules) on the face,
  3. Subjects with a minimum of 30 and a maximum of 100 non-inflammatory lesions (open comedones and closed comedones) on the face, excluding the nose.

Main exclusion criteria:

  1. Subjects with acne cystic lesions,
  2. Subjects with acne conglobate, acne fulminancy, secondary acne (chloracne, drug-induced acne, etc.).

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: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Percent change from Baseline in total lesion count (sum of non inflammatory and inflammatory lesions) at week 12.

Secondary Outcome Measures

Outcome Measure
Percent change from Baseline in total inflammatory and non inflammatory lesion counts at each intermediate visit
Global severity assessment at each post Baseline visit

Collaborators and Investigators

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

Sponsor

Galderma R&D

Investigators

  • Elisabeth ARTHUR, MD, Helendale Dermatology - Rochester NY - 585-266-5420
  • Alicia BUCKO, MD, Academic Dermatology Associates - Albuquerque NM - 505-247-4220
  • Paul YAMAUCHI, MD, Clinical Research Specialists, Inc. - Santa Monica CA - 310-828-8887
  • Steven E. KEMPERS, MD, Minnesota Clinical Study Center - Fridley MN - 763-571-4200
  • Principal Investigator: Harald GOLLNICK, MD, Otto-von-Guericke University - Magdeburg - Germany
  • Yvonne FRAMBACH, MD, Universitatsklinikum - Lubeck - Germany
  • Michael MEURER, MD, Dresden University - Dresden - Germany
  • Christos ZOUBOULIS, MD, Hautklinik und Immunologisches Zentrum des Städtischen Klinikum - Dessau - Germany
  • Roland KAUFMANN, MD, Zentrum fur Dermatoligie und Venerologie - Frankfurt - Germany
  • Thomas SCHWARZ, MD, Klinik fur Dermatologie, Venerologie und Allerologie - Kiel - Germany

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.

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

February 1, 2007

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

February 27, 2007

First Submitted That Met QC Criteria

February 27, 2007

First Posted (Estimate)

February 28, 2007

Study Record Updates

Last Update Posted (Actual)

February 17, 2021

Last Update Submitted That Met QC Criteria

February 16, 2021

Last Verified

August 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RD.03.SPR.29058

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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