Clinical Study to Test the Efficacy and Safety of Adapalene, 0.1%

February 16, 2021 updated by: Galderma R&D

A Multi-Center, Randomized, Double-Blind, Parallel Group Study to Demonstrate the Efficacy and Safety of Adapalene Lotion, 0.1% Compared With Vehicle Lotion in Subjects With Acne Vulgaris

The purpose of this study is to determine whether Adapalene, 0.1% is safe and effective in the treatment of Acne Vulgaris.

Study Overview

Status

Completed

Conditions

Detailed Description

This study will compare the efficacy and safety of Adapalene, 0.1% and vehicle in the treatment of subjects with Acne Vulgaris. This is a multi-center, randomized, double-blind, parallel, vehicle controlled study involving subjects with acne vulgaris meeting pre-specified inclusion/exclusion criteria. Male and female subjects, 12 years of age or older, with 20-50 papules and pustules and 30 to 100 non-inflammatory lesions and have an Investigator's Global Assessment (IGA) score of 3 (Moderate) or 4 (Severe) are eligible for enrollment. One nodule may be present at inclusion. Acne lesions are evaluated on the face only. Subjects presenting with facial and truncal acne vulgaris can participate in this study. Subjects will be randomized in a 1:1 ratio to Adapalene, 0.1% or Vehicle.

Study Type

Interventional

Enrollment (Actual)

1067

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

    • Alberta
      • Calgary, Alberta, Canada, T3A 2N1
        • Dermatology Associates
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 3Y1
        • Derm Research @ 888 Inc
    • Ontario
      • Barrie, Ontario, Canada, L4M 6L2
        • Ultranova Skincare
      • North Bay, Ontario, Canada, P1B 3Z7
        • North Bay Dermatology Centre
    • Quebec
      • Montreal, Quebec, Canada, H3G 1C6
        • Siena Medical Research
    • California
      • San Diego, California, United States, 92123
        • University of California
      • Vista, California, United States, 92083
        • Dermatology Specialists, Inc.
    • Colorado
      • Denver, Colorado, United States, 80246
        • Cherry Creek Dermatology
    • Florida
      • Ormond Beach, Florida, United States, 32174
        • Advanced Dermatology and Cosmetic Surgery
      • Pinellas Park, Florida, United States, 33781
        • Dermatology Research
    • Illinois
      • Champaign, Illinois, United States, 61820
        • Christie Clinic, PC
    • Kansas
      • Olathe, Kansas, United States, 66061
        • Compliant Clinical Research
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Dermatology Specialists
    • Massachusetts
      • Haverhill, Massachusetts, United States, 01830
        • East Coast Clinical Research, Inc.
    • Michigan
      • Clinton Township, Michigan, United States, 48038
        • Midwest Cutaneous Research
      • Detroit, Michigan, United States, 48202
        • Henry Ford Medical Center-Dept. of Dermatology
    • Minnesota
      • Fridley, Minnesota, United States, 55432
        • Minnesota Clinical Study Centert
    • Nebraska
      • Omaha, Nebraska, United States, 68144
        • Skin Specialists, PC
    • Nevada
      • Reno, Nevada, United States, 89511
        • Cindy Lamerson
    • New York
      • New York, New York, United States, 10021
        • Fran Cook-Bolden
      • Rochester, New York, United States, 14623
        • Dermatology Associates of Rochester
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina at Chapel Hill
      • Raleigh, North Carolina, United States, 27612
        • Wake Research Associates, LLC
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • University Dermatology Consultants
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
        • Central Sooner Research
    • Oregon
      • Portland, Oregon, United States, 97210
        • Northwest Cutaneous Research Specialists
    • South Carolina
      • Mount Pleasant, South Carolina, United States, 29464
        • Palmetto Medical Research
    • Tennessee
      • Knoxville, Tennessee, United States, 37917
        • Dermatology Associates
      • Nashville, Tennessee, United States, 37215
        • Tennessee Clinical Research Center
      • Nashville, Tennessee, United States, 37203
        • Dermatology Research Associates
    • Texas
      • Bryan, Texas, United States, 77802
        • J&S Studies, Inc.
      • Houston, Texas, United States, 77056
        • The Center for Skin Research
    • Utah
      • Salt Lake City, Utah, United States, 84124
        • Dermatology Research Center
    • Washington
      • Spokane, Washington, United States, 99204
        • Premier Clinical Research

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 and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects with Moderate or Severe Acne Vulgaris,
  • 20-50 papules and pustules in total on the face excluding the nose
  • 30-100 non-inflammatory lesions on the face excluding the nose.
  • Negative urine pregnancy test for all females.

Exclusion Criteria:

  • Subjects with more than one acne nodule.
  • Subjects with any acne cyst on the face.
  • Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), or severe acne requiring systemic treatment.
  • Subjects with underlying diseases or other dermatologic conditions that require the use of interfering topical or systemic therapy, such as, but not limited to, atopic dermatitis, perioral dermatitis or rosacea.
  • Subjects who are pregnant, nursing, or planning a pregnancy.

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adapalene lotion 0.1%
Adapalene, 0.1% will be applied topically to the face, once a day, for 12 weeks
Placebo Comparator: Adapalene Lotion vehicle
Vehicle will be applied topically to the face, once a day, for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Co-Primary Endpoint: Success Rate on Investigator's Global Assessment (IGA) From Baseline to Week 12
Time Frame: From Baseline to Week 12
Success defined as percentage of subjects who achieved at least a two-grade reduction in IGA scale (e.g from moderate to clear or almost clear)at week 12 from baseline, Last Observation Carried Forward, Intent to treat population. The IGA (Investigator Global Assessment) is defined as a 5 point scale (0 to 4). "0" = clear , "1"= almost clear, "2"= mild, "3"= moderate, "4"=severe.
From Baseline to Week 12
Co-Primary Endpoint: Absolute Change in Inflammatory Lesion Count From Baseline to Week 12
Time Frame: Baseline to Week 12
Baseline to Week 12
Co-Primary Endpoint: Absolute Change in NonInflammatory Lesion Counts From Baseline to Week 12
Time Frame: Baseline to Week 12
Baseline to Week 12
Co-Primary Endpoint: Absolute Change in Total Lesion Counts From Baseline to Week 12
Time Frame: Baseline to 12 weeks
Baseline to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Percent Change in Total Lesion Count From Baseline to Week 12
Time Frame: From Baseline to 12 weeks
Percent change in lesion count from baseline to week 12
From Baseline to 12 weeks

Collaborators and Investigators

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

Sponsor

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

November 1, 2007

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

January 11, 2008

First Submitted That Met QC Criteria

January 11, 2008

First Posted (Estimate)

January 23, 2008

Study Record Updates

Last Update Posted (Actual)

February 18, 2021

Last Update Submitted That Met QC Criteria

February 16, 2021

Last Verified

March 1, 2011

More Information

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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