Clinical trial NCT00598832: 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: 1075
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 Count From Baseline to Week 12
timeFrame: Baseline to Week 12
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 Week 12
Other outcomes:
Locations:
city: Hot Springs
country: United States
facility: Burke Pharmaceutical Research
state: Arkansas
city: Little Rock
country: United States
facility: Scott Dinehart
state: Arkansas
city: Marina Del Rey
country: United States
facility: Dermatology and Laser Center
state: California
city: San Diego
country: United States
facility: Therapeutics Clinical Research
state: California
city: Vallejo
country: United States
facility: Solano Clinical Research
state: California
city: Denver
country: United States
facility: Colorado Medical Research Center
state: Colorado
city: Longmont
country: United States
facility: Longmont Clinic
state: Colorado
city: Clermont
country: United States
facility: Advanced Dermatology
state: Florida
city: Miami
country: United States
facility: International Dermatology Research, Inc.
state: Florida
city: Augusta
country: United States
facility: Anne M. Loebl
state: Georgia
city: Buffalo Grove
country: United States
facility: Scott Glazer
state: Illinois
city: South Bend
country: United States
facility: Sound Bend Clinic
state: Indiana
city: Port Huron
country: United States
facility: Hamzavi Dermatology
state: Michigan
city: Saint Louis
country: United States
facility: Central Dermatology, PC
state: Missouri
city: Lebanon
country: United States
facility: Darmouth-Hitchcock Medical Center Section of Dermatology
state: New Hampshire
city: Albuquerque
country: United States
facility: Academic Dermatology
state: New Mexico
city: Rochester
country: United States
facility: Elizabeth Arthur
state: New York
city: Stony Brook
country: United States
facility: Derm Research Center of New York
state: New York
city: Hickory
country: United States
facility: Unifour Medical Research Associates
state: North Carolina
city: South Euclid
country: United States
facility: Haber Dermatology & Cosmetic Research
state: Ohio
city: Oklahoma City
country: United States
facility: OU Health Sciences Center-Dept. of Dermatology
state: Oklahoma
city: Portland
country: United States
facility: Oregon Medical Center, PC
state: Oregon
city: Goodlettsville
country: United States
facility: Rivergate Dermatology
state: Tennessee
city: Austin
country: United States
facility: DermResearch, Inc.
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research
state: Texas
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc.
state: Virginia
city: Calgary
country: Canada
facility: The Dermatology Centre
state: Alberta
city: Edmonton
country: Canada
facility: Stratica Medical
state: Alberta
city: Surrey
country: Canada
facility: Guildford Dermatology Specialists
state: British Columbia
city: Winnipeg
country: Canada
facility: Dermadvance Research
state: Manitoba
city: St. Johns
country: Canada
facility: Nexus Clinical Research
state: Newfoundland and Labrador
city: Markham
country: Canada
facility: Lynderm Research, Inc.
state: Ontario
city: Waterloo
country: Canada
facility: K. Papp Clinical Research, Inc.
state: Ontario
Study officials:
References: