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

Phase 3

Completed

Conditions: Acne Vulgaris

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

Registration Number: NCT00598832

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: 1075

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 vehicle	Adapalene Lotion Vehicle	-
Adapalene lotion 0.1%	Adapalene lotion 0.1%	-

Primary Outcome Measures

Name	Time	Method
Co-Primary Endpoint: Absolute Change in NonInflammatory Lesion Counts From Baseline to Week 12	Baseline to Week 12
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 Total Lesion Count From Baseline to Week 12	Baseline to Week 12
Co-Primary Endpoint: Absolute Change in Inflammatory Lesion Count 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 Week 12	Percent change in lesion count from baseline to week 12

Trial Locations

Locations (34): Lynderm Research, Inc.
🇨🇦
Markham, Ontario, Canada
Central Dermatology, PC
🇺🇸
Saint Louis, Missouri, United States
Therapeutics Clinical Research
🇺🇸
San Diego, California, United States
Progressive Clinical Research
🇺🇸
San Antonio, Texas, United States
Colorado Medical Research Center
🇺🇸
Denver, Colorado, United States
Oregon Medical Center, PC
🇺🇸
Portland, Oregon, United States
Burke Pharmaceutical Research
🇺🇸
Hot Springs, Arkansas, United States
Dermatology and Laser Center
🇺🇸
Marina Del Rey, California, United States
Scott Dinehart
🇺🇸
Little Rock, Arkansas, United States
Solano Clinical Research
🇺🇸
Vallejo, California, United States
Advanced Dermatology
🇺🇸
Clermont, Florida, United States
Longmont Clinic
🇺🇸
Longmont, Colorado, United States
International Dermatology Research, Inc.
🇺🇸
Miami, Florida, United States
Anne M. Loebl
🇺🇸
Augusta, Georgia, United States
Scott Glazer
🇺🇸
Buffalo Grove, Illinois, United States
Hamzavi Dermatology
🇺🇸
Port Huron, Michigan, United States
Darmouth-Hitchcock Medical Center Section of Dermatology
🇺🇸
Lebanon, New Hampshire, United States
Academic Dermatology
🇺🇸
Albuquerque, New Mexico, United States
Elizabeth Arthur
🇺🇸
Rochester, New York, United States
Derm Research Center of New York
🇺🇸
Stony Brook, New York, United States
OU Health Sciences Center-Dept. of Dermatology
🇺🇸
Oklahoma City, Oklahoma, United States
Haber Dermatology & Cosmetic Research
🇺🇸
South Euclid, Ohio, United States
DermResearch, Inc.
🇺🇸
Austin, Texas, United States
Unifour Medical Research Associates
🇺🇸
Hickory, North Carolina, United States
Center for Clinical Studies
🇺🇸
Houston, Texas, United States
Virginia Clinical Research, Inc.
🇺🇸
Norfolk, Virginia, United States
Stratica Medical
🇨🇦
Edmonton, Alberta, Canada
Dermadvance Research
🇨🇦
Winnipeg, Manitoba, Canada
Guildford Dermatology Specialists
🇨🇦
Surrey, British Columbia, Canada
Nexus Clinical Research
🇨🇦
St. Johns, Newfoundland and Labrador, Canada
K. Papp Clinical Research, Inc.
🇨🇦
Waterloo, Ontario, Canada
Sound Bend Clinic
🇺🇸
South Bend, Indiana, United States
Rivergate Dermatology
🇺🇸
Goodlettsville, Tennessee, United States
The Dermatology Centre
🇨🇦
Calgary, Alberta, Canada