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

NCT00599521

Run by

Galderma R&D

People needed

1067

Starts

2007-11-01

Expected to finish

2008-12-01

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

• University of California — San Diego, California, United States
• Dermatology Specialists, Inc. — Vista, California, United States
• Cherry Creek Dermatology — Denver, Colorado, United States
• Advanced Dermatology and Cosmetic Surgery — Ormond Beach, Florida, United States
• Dermatology Research — Pinellas Park, Florida, United States
• Christie Clinic, PC — Champaign, Illinois, United States
• Compliant Clinical Research — Olathe, Kansas, United States
• Dermatology Specialists — Louisville, Kentucky, United States
• East Coast Clinical Research, Inc. — Haverhill, Massachusetts, United States
• Midwest Cutaneous Research — Clinton Township, Michigan, United States
• Henry Ford Medical Center-Dept. of Dermatology — Detroit, Michigan, United States
• Minnesota Clinical Study Centert — Fridley, Minnesota, United States
• Skin Specialists, PC — Omaha, Nebraska, United States
• Cindy Lamerson — Reno, Nevada, United States
• Fran Cook-Bolden — New York, New York, United States
• Dermatology Associates of Rochester — Rochester, New York, United States
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Wake Research Associates, LLC — Raleigh, North Carolina, United States
• University Dermatology Consultants — Cincinnati, Ohio, United States
• Central Sooner Research — Norman, Oklahoma, United States
• Northwest Cutaneous Research Specialists — Portland, Oregon, United States
• Palmetto Medical Research — Mt. Pleasant, South Carolina, United States
• Dermatology Associates — Knoxville, Tennessee, United States
• Dermatology Research Associates — Nashville, Tennessee, United States
• Tennessee Clinical Research Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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