Safety and Efficacy of a Retinoid for the Treatment of Severe Chronic Hand Dermatitis

Hand Dermatoses Clinical Trial

Official title: Safety and Efficacy of Alitretinoin in the Treatment of Severe Refractory Chronic Hand Dermatitis

Status Completed

Clinical Trial Summary

Patients with severe chronic hand dermatitis, that has not responded to topical treatment, including topical steroids and the avoidance of aggravating factors, will be treated with the oral medication alitretinoin. The study aims to investigate the safety and efficacy of the medication when given over a period of 6 months.

Clinical Trial Description

For severe, chronic hand dermatitis, refractory to topical treatment and the avoidance of aggravating factors such as allergens and irritants, no registered systemic treatment is available. Current systemic treatment options consist in the off-label use of systemic immune suppressants, such as cyclosporine, methotrexate.

Severe chronic hand dermatitis is a debilitating disease, with massive impact on social life and working ability. A huge proportion of the population suffers for more than a decade, and job losses are a frequent consequence.

This open-label trial investigates the safety and efficacy of oral alitretinoin 30mg as a single daily dose for up to 6 months. The trial is complementary to the pivotal efficacy study BAP00089. ;

Related Conditions & MeSH terms

• Dermatitis
• Hand Dermatoses
• Skin Diseases

• NCT number: NCT00309621
• Study type: Interventional
• Source: Basilea Pharmaceutica
• Status: Completed
• Phase: Phase 3
• Start date: April 2006
• Completion date: May 2007