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Alitretinoin in the Treatment of Chronic Hand Eczema

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00519675
First Posted: August 23, 2007
Last Update Posted: July 19, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Basilea Pharmaceutica
  Purpose
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: None (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.
  Eligibility

Information from the National Library of Medicine

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

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
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): NCT00519675


Locations
France
Paris, France
Saint Etienne, France
Germany
Berlin, Germany
Dresden, Germany
Sponsors and Collaborators
Basilea Pharmaceutica
Investigators
Study Director: Jürgen Maares, MD Basilea Pharmaceutica
  More Information

ClinicalTrials.gov Identifier: NCT00519675     History of Changes
Other Study ID Numbers: BAP00731
First Submitted: August 22, 2007
First Posted: August 23, 2007
Last Update Posted: July 19, 2010
Last Verified: July 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:
Eczema
Dermatitis
Skin Diseases
Skin Diseases, Eczematous
Alitretinoin
Tretinoin
Antineoplastic Agents
Keratolytic Agents
Dermatologic Agents