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Alitretinoin in the Treatment of Chronic Hand Eczema

This study has been completed.
Information provided by:
Basilea Pharmaceutica Identifier:
First received: August 22, 2007
Last updated: July 16, 2010
Last verified: July 2010
The purpose of the study is to investigate the safety and efficacy of alitretinoin in chronic hand eczema that is refractory to topical corticosteroids.

Condition Intervention Phase
Eczema Drug: alitretinoin Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open Label Treatment of Patients With Chronic Hand Dermatitis Who Have Participated in a Previous Clinical Trial Involving Oral Alitretinoin

Resource links provided by NLM:

Further study details as provided by Basilea Pharmaceutica:

Primary Outcome Measures:
  • Safety assessments

Secondary Outcome Measures:
  • Efficacy (Physicians Global Assessment)

Estimated Enrollment: 150
Study Start Date: May 2007
Detailed Description:
Chronic hand eczema is a frequent and distressing disease. The course of the disease is of chronic-relapsing nature. In a phase III study alitretinoin was clinically effective for patients with severe chronic hand eczema refractory to topical treatment. This study investigates the safety and efficacy of alitretinoin who previously have participated in a clinical trial involving alitretinoin.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Previous participation in therapeutic trials involving chronic hand eczema
  • Relapse of chronic hand eczema, defined as 75% of the baseline initial total lesion symptom score

Exclusion Criteria:

  • Patients whose disease is adequately controlled by standard non-medicated skin care and topical corticosteroid therapy
  Contacts and Locations
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Please refer to this study by its identifier: NCT00519675

Paris, France
Saint Etienne, France
Berlin, Germany
Dresden, Germany
Sponsors and Collaborators
Basilea Pharmaceutica
Study Director: Jürgen Maares, MD Basilea Pharmaceutica
  More Information Identifier: NCT00519675     History of Changes
Other Study ID Numbers: BAP00731
Study First Received: August 22, 2007
Last Updated: July 16, 2010

Keywords provided by Basilea Pharmaceutica:
Chronic hand eczema
Chronic hand dermatitis
Patients with chronic hand eczema, who are refractory to topical corticosteroids

Additional relevant MeSH terms:
Skin Diseases
Skin Diseases, Eczematous
Antineoplastic Agents
Keratolytic Agents
Dermatologic Agents processed this record on June 23, 2017