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OpenTrials
Completed

NCT Number: NCT00124475

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

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Thomas Ruzicka, MD

Düsseldorf, 40225, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alitretinoin

Drug

Primary outcomes

  1. Physicians global assessment

  2. at week 12 or 24

Secondary outcomes

  1. Response rate per treatment group

  2. Modified total lesion symptom score

  3. Patients global assessment

  4. at week 12 or 24

  5. Time to relapse

Sponsors and collaborators

Lead sponsor

Basilea Pharmaceutica

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2006
Study completion
2007
First posted
Jul 28, 2005
Registry last updated
May 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.