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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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

Detailed Summary:

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.


Sponsor: Basilea Pharmaceutica

Current Primary Outcome:

  • Physicians global assessment
  • at week 12 or 24


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Response rate per treatment group
  • Modified total lesion symptom score
  • Patients global assessment
  • at week 12 or 24
  • Time to relapse


Original Secondary Outcome: Same as current

Information By: Basilea Pharmaceutica

Dates:
Date Received: July 26, 2005
Date Started: December 2004
Date Completion:
Last Updated: July 16, 2010
Last Verified: July 2010