Alitretinoin in the Treatment of Chronic Hand Eczema

This study has been completed.

First Received: August 22, 2007 Last Updated: May 20, 2009 History of Changes

Sponsor:	Basilea Pharmaceutica
Information provided by:	Basilea Pharmaceutica
ClinicalTrials.gov Identifier:	NCT00519675

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 III

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Eczema

Drug Information available for: 9-cis-Retinoic acid

U.S. FDA Resources

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

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00519675

Locations

France

Saint Etienne, France

Paris, France
Germany

Berlin, Germany

Dresden, Germany

Sponsors and Collaborators

Basilea Pharmaceutica

Investigators

Study Director:

Jürgen Maares, MD

Basilea Pharmaceutica

More Information

No publications provided

Study ID Numbers:	BAP00731
Study First Received:	August 22, 2007
Last Updated:	May 20, 2009
ClinicalTrials.gov Identifier:	NCT00519675 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices

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:

Alitretinoin
Skin Diseases
Antineoplastic Agents
Therapeutic Uses

Skin Diseases, Eczematous
Eczema
Pharmacologic Actions
Dermatitis

ClinicalTrials.gov processed this record on November 27, 2009