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

Phase 3

Completed

• Conditions: Hand Dermatoses

• Registration Number: NCT00124475
• Lead Sponsor: Basilea Pharmaceutica

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 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.

Study Timeline

• Study Start: 2004-12
• Study First Submitted: 2005-07-26
• Study First Submitted QC: 2005-07-27
• Study First Posted: 2005-07-28
• Primary Completion: 2006-10
• Study Completion: 2007-09
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-09
• Last Update Posted: 2023-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1035

Inclusion Criteria

• Chronic hand dermatitis, all types including hyperkeratotic, vesicular, fingertip dermatitis
• Lasting for 6 months since initial diagnosis
• Rated severe
• Refractory to standard therapy including non-medicated therapy and avoidance of irritants and allergens
• Refractory to topical steroids

Exclusion Criteria

• Female patients who are pregnant or want to become pregnant
• Female patients of child bearing potential who cannot use or will not commit to using two effective forms of contraception simultaneously
• Patients whose disease is adequately controlled by standard non-medicated therapy and standard corticosteroid therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Physicians global assessment
at week 12 or 24

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Thomas Ruzicka, MD; 🇩🇪 Düsseldorf, Germany