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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1720 2nd Ave S
Birmingham, Alabama 35233
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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
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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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5301 Keystone Court
Arlington Heights, Illinois 60005
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111 Colchester Ave
Burlington, Vermont 05401
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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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Fridley, Minnesota 55432
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1 Medical Center Dr
Lebanon, New Hampshire 03756
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1845 Walnut Street
Philadelphia, Pennsylvania 19103
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Pittsburgh, Pennsylvania 15213
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Sacramento, California 95616
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