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

This study has been completed.
Sponsor:
Information provided by:
Basilea Pharmaceutica
ClinicalTrials.gov Identifier:
NCT00124475
First received: July 26, 2005
Last updated: July 16, 2010
Last verified: July 2010
History of Changes
  Purpose

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


Condition Intervention Phase
Hand Dermatoses
 Drug: alitretinoin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Efficacy and Safety of BAL4079 in the Treatment of Severe Refractory Chronic Hand Dermatitis

Resource links provided by NLM:

MedlinePlus related topics: Skin Conditions
U.S. FDA Resources

Further study details as provided by Basilea Pharmaceutica:

Primary Outcome Measures:
  • Physicians global assessment
  • at week 12 or 24

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

Estimated Enrollment: 1035
Study Start Date: December 2004
Study Completion Date: September 2007
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00124475

Locations
Germany
Thomas Ruzicka, MD
Düsseldorf, Germany, 40225
Sponsors and Collaborators
Basilea Pharmaceutica
Investigators
Principal Investigator: Thomas Ruzicka, MD University of Düsseldorf, Dermatological Hospital, Germany
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00124475     History of Changes
Other Study ID Numbers: BAP00089
Study First Received: July 26, 2005
Last Updated: July 16, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Denmark: Danish Medicines Agency
Poland: Ministry of Health
Hungary: National Institute of Pharmacy
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Netherlands: Medicines Evaluation Board (MEB)
Czech Republic: State Institute for Drug Control
Canada: Health Canada

Keywords provided by Basilea Pharmaceutica:
Chronic Hand Dermatitis

Additional relevant MeSH terms:
Dermatitis
Hand Dermatoses
Skin Diseases
Alitretinoin
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013