Clinical Study to Test the Efficacy and Safety of Adapalene, 0.1%
NCT ID: NCT00598832
Last Updated: 2021-02-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1075 participants
INTERVENTIONAL
2007-11-30
2008-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Adapalene lotion 0.1%
Adapalene lotion 0.1%
Adapalene, 0.1% will be applied topically to the face, once a day, for 12 weeks
Adapalene Lotion vehicle
Adapalene Lotion Vehicle
Adapalene Lotion Vehicle will be applied topically to the face, once a day, for 12 weeks
Interventions
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Adapalene lotion 0.1%
Adapalene, 0.1% will be applied topically to the face, once a day, for 12 weeks
Adapalene Lotion Vehicle
Adapalene Lotion Vehicle will be applied topically to the face, once a day, for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* 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 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.
12 Years
ALL
No
Sponsors
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Galderma R&D
INDUSTRY
Responsible Party
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Galderma
Locations
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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
Scott Glazer
Buffalo Grove, Illinois, United States
Sound Bend Clinic
South Bend, Indiana, United States
Hamzavi Dermatology
Port Huron, Michigan, United States
Central Dermatology, PC
St Louis, Missouri, 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
Unifour Medical Research Associates
Hickory, North Carolina, United States
Haber Dermatology & Cosmetic Research
South Euclid, Ohio, United States
OU Health Sciences Center-Dept. of Dermatology
Oklahoma City, Oklahoma, United States
Oregon Medical Center, PC
Portland, Oregon, United States
Rivergate Dermatology
Goodlettsville, Tennessee, United States
DermResearch, Inc.
Austin, Texas, United States
Center for Clinical Studies
Houston, Texas, United States
Progressive Clinical Research
San Antonio, Texas, United States
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States
The Dermatology Centre
Calgary, Alberta, Canada
Stratica Medical
Edmonton, Alberta, Canada
Guildford Dermatology Specialists
Surrey, British Columbia, Canada
Dermadvance Research
Winnipeg, Manitoba, Canada
Nexus Clinical Research
St. John's, Newfoundland and Labrador, Canada
Lynderm Research, Inc.
Markham, Ontario, Canada
K. Papp Clinical Research, Inc.
Waterloo, Ontario, Canada
Countries
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Other Identifiers
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IND 076057
Identifier Type: -
Identifier Source: secondary_id
RD.06.SPR.18113
Identifier Type: -
Identifier Source: org_study_id
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