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

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ClinicalTrials.gov Identifier: NCT00124475
Recruitment Status : Completed
First Posted : July 28, 2005
Last Update Posted : July 19, 2010
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Hand Dermatoses Drug: alitretinoin Phase 3

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1035 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Efficacy and Safety of BAL4079 in the Treatment of Severe Refractory Chronic Hand Dermatitis
Study Start Date : December 2004
Primary Completion Date : October 2006
Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Physicians global assessment
  2. at week 12 or 24

Secondary Outcome Measures :
  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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
ClinicalTrials.gov Identifier: NCT00124475     History of Changes
Other Study ID Numbers: BAP00089
First Posted: July 28, 2005    Key Record Dates
Last Update Posted: July 19, 2010
Last Verified: July 2010

Keywords provided by Basilea Pharmaceutica:
Chronic Hand Dermatitis

Additional relevant MeSH terms:
Dermatitis
Skin Diseases
Hand Dermatoses
Alitretinoin
Antineoplastic Agents