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

Phase 3

Completed

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

Inclusion Criteria

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.

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

Locations (34): Burke Pharmaceutical Research
🇺🇸
Hot Springs, Arkansas, United States
Scott Dinehart
🇺🇸
Little Rock, Arkansas, United States
Dermatology and Laser Center
🇺🇸
Marina Del Rey, California, United States
Therapeutics Clinical Research
🇺🇸
San Diego, California, United States
Solano Clinical Research
🇺🇸
Vallejo, California, United States
Colorado Medical Research Center
🇺🇸
Denver, Colorado, United States
Longmont Clinic
🇺🇸
Longmont, Colorado, United States
Advanced Dermatology
🇺🇸
Clermont, Florida, United States
International Dermatology Research, Inc.
🇺🇸
Miami, Florida, United States
Anne M. Loebl
🇺🇸
Augusta, Georgia, United States
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Burke Pharmaceutical Research
🇺🇸Hot Springs, Arkansas, United States