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

Completed · Phase 3

Conditions studied: Acne Vulgaris

In brief

The purpose of this study is to determine whether Adapalene, 0.1% is safe and effective in the treatment of Acne Vulgaris.

Key facts

Study ID

NCT00598832

Run by

Galderma R&D

People needed

1075

Starts

2007-11-01

Expected to finish

2008-11-01

Last updated by the study team

2021-02-18

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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