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Efficacy and Safety of a Retinoid in the Treatment of Severe Chronic Hand Eczema - NCT00817063-27157(Clinical Trial 262407)



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City:  Winston-Salem
State:  
NC
Zip Code: 27157
Conditions: Chronic Hand Eczema - Chronic Hand Dermatitis
Purpose: 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.
Study summary: 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.
Criteria: 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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Data Source: ClinicalTrials.gov
Date Processed: January 5, 2011
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