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

Phase 3

Completed

Conditions: Acne Vulgaris

Interventions: Drug: Adapalene lotion 0.1%
Drug: Adapalene Lotion Vehicle

Registration Number: NCT00599521

Lead Sponsor: Galderma R&D

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

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1067

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adapalene lotion 0.1%	Adapalene lotion 0.1%	-
Adapalene Lotion vehicle	Adapalene Lotion Vehicle	-

Primary Outcome Measures

Name	Time	Method
Co-Primary Endpoint: Success Rate on Investigator's Global Assessment (IGA) From Baseline to Week 12	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.
Co-Primary Endpoint: Absolute Change in Inflammatory Lesion Count From Baseline to Week 12	Baseline to Week 12
Co-Primary Endpoint: Absolute Change in Total Lesion Counts From Baseline to Week 12	Baseline to 12 weeks
Co-Primary Endpoint: Absolute Change in NonInflammatory Lesion Counts From Baseline to Week 12	Baseline to Week 12

Secondary Outcome Measures

Name	Time	Method
Mean Percent Change in Total Lesion Count From Baseline to Week 12	From Baseline to 12 weeks	Percent change in lesion count from baseline to week 12

Trial Locations

Locations (33): East Coast Clinical Research, Inc.
🇺🇸
Haverhill, Massachusetts, United States
Dermatology Associates of Rochester
🇺🇸
Rochester, New York, United States
J&S Studies, Inc.
🇺🇸
Bryan, Texas, United States
Advanced Dermatology and Cosmetic Surgery
🇺🇸
Ormond Beach, Florida, United States
Compliant Clinical Research
🇺🇸
Olathe, Kansas, United States
Cindy Lamerson
🇺🇸
Reno, Nevada, United States
Midwest Cutaneous Research
🇺🇸
Clinton Township, Michigan, United States
Dermatology Associates
🇨🇦
Calgary, Alberta, Canada
Premier Clinical Research
🇺🇸
Spokane, Washington, United States
Minnesota Clinical Study Centert
🇺🇸
Fridley, Minnesota, United States
Fran Cook-Bolden
🇺🇸
New York, New York, United States
Wake Research Associates, LLC
🇺🇸
Raleigh, North Carolina, United States
Siena Medical Research
🇨🇦
Montreal, Quebec, Canada
University Dermatology Consultants
🇺🇸
Cincinnati, Ohio, United States
University of California
🇺🇸
San Diego, California, United States
Cherry Creek Dermatology
🇺🇸
Denver, Colorado, United States
Dermatology Research Associates
🇺🇸
Nashville, Tennessee, United States
Tennessee Clinical Research Center
🇺🇸
Nashville, Tennessee, United States
Henry Ford Medical Center-Dept. of Dermatology
🇺🇸
Detroit, Michigan, United States
Northwest Cutaneous Research Specialists
🇺🇸
Portland, Oregon, United States
Central Sooner Research
🇺🇸
Norman, Oklahoma, United States
The Center for Skin Research
🇺🇸
Houston, Texas, United States
Dermatology Research Center
🇺🇸
Salt Lake City, Utah, United States
Ultranova Skincare
🇨🇦
Barrie, Ontario, Canada
Dermatology Specialists, Inc.
🇺🇸
Vista, California, United States
Christie Clinic, PC
🇺🇸
Champaign, Illinois, United States
Dermatology Research
🇺🇸
Pinellas Park, Florida, United States
Palmetto Medical Research
🇺🇸
Mount Pleasant, South Carolina, United States
North Bay Dermatology Centre
🇨🇦
North Bay, Ontario, Canada
Derm Research @ 888 Inc
🇨🇦
Vancouver, British Columbia, Canada
Dermatology Specialists
🇺🇸
Louisville, Kentucky, United States
Skin Specialists, PC
🇺🇸
Omaha, Nebraska, United States
University of North Carolina at Chapel Hill
🇺🇸
Chapel Hill, North Carolina, United States