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



Status:Completed
Conditions:Skin and Soft Tissue Infections, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - 75
Updated:11/11/2017
Start Date:January 8, 2009
End Date:April 26, 2012

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Efficacy and Safety of Alitretinoin in the Treatment of Severe Chronic Hand Eczema Refractory to Topical Therapy

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.

Chronic hand eczema (CHE)is a distressing disease that poses difficult problems for
dermatologists. CHE leads to considerable work-absenteeism, disability and exclusion from
labour market. Conventional treatments, including highly potent topical steroids, yield often
unsatisfactory results. This study investigates the efficacy and safety of oral alitretinoin,
a retinoid, in patients who have not responded to avoidance of causative factors, such as
contact allergens and skin irritants, non-medicated skin care and highly potent topical
steroids. Eligible patients are randomly assigned to receive alitretinoin or a placebo.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
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Warren, Michigan 48093
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
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7810 Louis Pasteur
San Antonio, Texas 78229
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1897 Palm Beach Lakes Boulevard
West Palm Beach, Florida 33409
561-689-0606
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Arlington, Texas 76011
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Belleville, Illinois 62226
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Bellingham, Washington 98225
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111 Colchester Ave
Burlington, Vermont 05401
(802) 847-0000
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Chapel Hill, North Carolina 91884
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Cincinnati, Ohio 45231
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Dallas, Texas 75231
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Edina, Minnesota 55435
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Evansville, Indiana 47713
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2950 Keewahdin Road
Fort Gratiot, Michigan 48059
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Fort Smith, Arkansas 72916
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7205 University Avenue Northeast
Fridley, Minnesota 55432
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Grand Blanc, Michigan 48439
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Houston, Texas 77030
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Indianapolis, Indiana 46202
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La Jolla, California 92037
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
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Lincoln, Nebraska 68502
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9601 Baptist Health Drive
Little Rock, Arkansas 72205
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Madison, Wisconsin 53719
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4560 Admiralty Way
Marina del Rey, California 90292
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Nampa, Idaho 83686
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1 Gustave L. Levy Place
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Norfolk, Virginia 23507
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1845 Walnut Street
Philadelphia, Pennsylvania 19103
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
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1100 Southfield Drive
Plainfield, Indiana 46168
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Rochester, New York 14609
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Rogers, Arkansas 72758
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1 Shields Ave
Sacramento, California 95616
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Saint Louis, Missouri 63110
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324 South Sherman Street
Seattle, Washington 99204
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Shawnee, Kansas 66216
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Somerset, New Jersey 08873
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Stanford, California 94305
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Toccoa, Georgia 30577
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Washington, D.C., District of Columbia 20037
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West Dundee, Illinois 60118
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4251 Kipling Street
Wheat Ridge, Colorado 80033
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Wilmington, North Carolina 28403
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