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Alitretinoin in the Treatment of Chronic Hand Eczema

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ClinicalTrials.gov Identifier: NCT00519675
Recruitment Status : Completed
First Posted : August 23, 2007
Last Update Posted : July 19, 2010
Sponsor:
Information provided by:
Basilea Pharmaceutica

Brief Summary:
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 or disease Intervention/treatment Phase
Eczema Drug: alitretinoin Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
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
Study Start Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
U.S. FDA Resources




Primary Outcome Measures :
  1. Safety assessments

Secondary Outcome Measures :
  1. Efficacy (Physicians Global Assessment)


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

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

ClinicalTrials.gov Identifier: NCT00519675     History of Changes
Other Study ID Numbers: BAP00731
First Posted: August 23, 2007    Key Record Dates
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