NCT00309621

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 250 (planned)
• Sponsor: Basilea Pharmaceutica · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Hand Dermatoses

Interventions

Type	Name	Description
DRUG	alitretinoin

Timeline

• Start date: 2006-04-01
• Primary completion: 2007-04-01
• Completion: 2007-05-01
• First posted: 2006-04-03
• Last updated: 2023-05-10

Locations

33 sites across 3 countries: Canada, Germany, Poland