Efficacy and Safety of a Retinoid in the Treatment of Severe Chronic Hand Eczema

Completed · Phase 3 · Has a placebo group

Conditions studied: Eczema

In brief

The purpose of this study is to investigate the safety and efficacy of alitretinoin in the treatment of severe chronic hand eczema that does not respond to treatment with potent topical steroids.

Key facts

Study ID

NCT00817063

Run by

Stiefel, a GSK Company

People needed

599

Starts

2009-01-08

Expected to finish

2012-04-26

Last updated by the study team

2020-04-27

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• all types of chronic hand eczema, lasting for at least 6 months since initial diagnosis
• rated as severe by the physician
• unresponsive to highly potent topical corticosteroids, such as clobetasol

You may not qualify if…

• patients whose disease is adequately controlled by standard non-medicated therapy, including potent topical steroids, skin moisturizers, and avoidance of allergens and irritants
• patients with known allergens and irritants, who have not made a reasonable effort to avoid the substances
• patients with psoriasis lesions
• active fungal, bacterial or viral infections of the hands
• female patients who are pregnant or breastfeeding
• female patients of childbearing potential who cannot use or will not commit to use two effective methods of contraception

Where it is running

• Laser and Dermatology Center — Marina del Rey, California, United States
• Integrated Research Group — Riverside, California, United States
• University of California, Davis — Sacramento, California, United States
• Therapeutics Clinical Research — San Diego, California, United States
• East Bay Psoriasis Treatment Center — San Ramon, California, United States
• Stanford University Dept of Dermatology — Stanford, California, United States
• Solano Clinical Research, Dow Pharmaceutical Sciences — Vallejo, California, United States
• Longmont Clinic, P.C. — Longmont, Colorado, United States
• Western State Clinical Research Inc. — Wheat Ridge, Colorado, United States
• George Washington University - Medical Faculty Associates — Washington D.C., District of Columbia, United States
• Park Avenue Dermatology, PA — Orange Park, Florida, United States
• Palm Beach Research Center — West Palm Beach, Florida, United States
• Toccoa Clinic Medical Associates — Toccoa, Georgia, United States
• Saltzer Medical Group — Nampa, Idaho, United States
• Michael Bukhalo MD — Arlington Heights, Illinois, United States
• Dermassociates, Ltd — Belleville, Illinois, United States
• Schaumburg Dermatology — Schaumburg, Illinois, United States
• Dundee Dermatology — West Dundee, Illinois, United States
• Deaconess Clinic, Inc. — Evansville, Indiana, United States
• Indiana University Dermatology — Indianapolis, Indiana, United States
• The Dermatology Center — New Albany, Indiana, United States
• Dermatology Center of Indiana/Indiana Clinical Trials Center — Plainfield, Indiana, United States
• Kansas City Dermatology, PA — Overland Park, Kansas, United States
• American Dermatology Association — Shawnee Mission, Kansas, United States
• Dermatology Research Associates — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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