Clinical trial NCT00599521: Clinical Study to Test the Efficacy and Safety of Adapalene, 0.1%
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acne Vulgaris
Keywords: Acne Vulgaris
Adapalene
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2008-01-23
Enrollment: 1067
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Co-Primary Endpoint: Success Rate on Investigator's Global Assessment (IGA) From Baseline to Week 12
timeFrame: From Baseline to Week 12
measure: Co-Primary Endpoint: Absolute Change in Total Lesion Counts From Baseline to Week 12
timeFrame: Baseline to 12 weeks
measure: Co-Primary Endpoint: Absolute Change in Inflammatory Lesion Count From Baseline to Week 12
timeFrame: Baseline to Week 12
measure: Co-Primary Endpoint: Absolute Change in NonInflammatory Lesion Counts From Baseline to Week 12
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Mean Percent Change in Total Lesion Count From Baseline to Week 12
timeFrame: From Baseline to 12 weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California
state: California
city: Vista
country: United States
facility: Dermatology Specialists, Inc.
state: California
city: Denver
country: United States
facility: Cherry Creek Dermatology
state: Colorado
city: Ormond Beach
country: United States
facility: Advanced Dermatology and Cosmetic Surgery
state: Florida
city: Pinellas Park
country: United States
facility: Dermatology Research
state: Florida
city: Champaign
country: United States
facility: Christie Clinic, PC
state: Illinois
city: Olathe
country: United States
facility: Compliant Clinical Research
state: Kansas
city: Louisville
country: United States
facility: Dermatology Specialists
state: Kentucky
city: Haverhill
country: United States
facility: East Coast Clinical Research, Inc.
state: Massachusetts
city: Clinton Township
country: United States
facility: Midwest Cutaneous Research
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Medical Center-Dept. of Dermatology
state: Michigan
city: Fridley
country: United States
facility: Minnesota Clinical Study Centert
state: Minnesota
city: Omaha
country: United States
facility: Skin Specialists, PC
state: Nebraska
city: Reno
country: United States
facility: Cindy Lamerson
state: Nevada
city: New York
country: United States
facility: Fran Cook-Bolden
state: New York
city: Rochester
country: United States
facility: Dermatology Associates of Rochester
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates, LLC
state: North Carolina
city: Cincinnati
country: United States
facility: University Dermatology Consultants
state: Ohio
city: Norman
country: United States
facility: Central Sooner Research
state: Oklahoma
city: Portland
country: United States
facility: Northwest Cutaneous Research Specialists
state: Oregon
city: Mount Pleasant
country: United States
facility: Palmetto Medical Research
state: South Carolina
city: Knoxville
country: United States
facility: Dermatology Associates
state: Tennessee
city: Nashville
country: United States
facility: Dermatology Research Associates
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Clinical Research Center
state: Tennessee
city: Bryan
country: United States
facility: J&S Studies, Inc.
state: Texas
city: Houston
country: United States
facility: The Center for Skin Research
state: Texas
city: Salt Lake City
country: United States
facility: Dermatology Research Center
state: Utah
city: Spokane
country: United States
facility: Premier Clinical Research
state: Washington
city: Calgary
country: Canada
facility: Dermatology Associates
state: Alberta
city: Vancouver
country: Canada
facility: Derm Research @ 888 Inc
state: British Columbia
city: Barrie
country: Canada
facility: Ultranova Skincare
state: Ontario
city: North Bay
country: Canada
facility: North Bay Dermatology Centre
state: Ontario
city: Montreal
country: Canada
facility: Siena Medical Research
state: Quebec
Study officials:
References: