Alitretinoin in the Treatment of Chronic Hand Eczema - Tabular View

Tracking Information

First Received Date ^ICMJE

August 22, 2007

Last Updated Date

May 20, 2009

Start Date ^ICMJE

May 2007

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Safety assessments

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00519675 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Efficacy (Physicians Global Assessment)

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Alitretinoin in the Treatment of Chronic Hand Eczema

Official Title ^ICMJE

Open Label Treatment of Patients With Chronic Hand Dermatitis Who Have Participated in a Previous Clinical Trial Involving Oral Alitretinoin

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.

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 Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Eczema

Intervention ^ICMJE

Drug: alitretinoin

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

150

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France, Germany

Administrative Information

NCT ID ^ICMJE

NCT00519675

Responsible Party

Study ID Numbers ^ICMJE

BAP00731

Study Sponsor ^ICMJE

Basilea Pharmaceutica

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Jürgen Maares, MD

Basilea Pharmaceutica

Information Provided By

Basilea Pharmaceutica

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP