NCT00124475

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

Efficacy and Safety of BAL4079 in the Treatment of Severe Refractory Chronic Hand Dermatitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,035 (planned)
• Sponsor: Basilea Pharmaceutica · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to determine the therapeutic effect of alitretinoin, a retinoid, on severe, therapy refractory chronic hand dermatitis.

Detailed description

Chronic hand dermatitis (CHaD) is a frequent and distressing disease. Conventional treatments yield mostly unsatisfactory results. In addition, chronic hand dermatitis leads to 2-5% of all applications for permanent disability pensions in some western countries. In a therapeutic dose finding study alitretinoin was clinically effective for patients with moderate to severe chronic hand dermatitis refractory to topical treatment. Patients with severe refractory CHaD will be allocated either of two active treatments or placebo. The primary objective is to demonstrate the response rate based on physicians global assessment of the disease.

Conditions

• Hand Dermatoses

Interventions

Type	Name	Description
DRUG	alitretinoin

Timeline

• Start date: 2004-12-01
• Primary completion: 2006-10-01
• Completion: 2007-09-01
• First posted: 2005-07-28
• Last updated: 2023-05-10

Locations

1 site across 1 country: Germany