Alitretinoin in the Treatment of Chronic Hand Eczema

May 9, 2023 updated by: Basilea Pharmaceutica

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

The purpose of the study is to investigate the safety and efficacy of alitretinoin in chronic hand eczema that is refractory to topical corticosteroids.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

150

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France
      • Saint Etienne, France
  • Germany
      • Berlin, Germany
      • Dresden, Germany

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Safety assessments

Secondary Outcome Measures

Outcome Measure
Efficacy (Physicians Global Assessment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Basilea Pharmaceutica

Investigators

  • Study Director: Jürgen Maares, MD, Basilea Pharmaceutica

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Study Registration Dates

First Submitted

August 22, 2007

First Submitted That Met QC Criteria

August 22, 2007

First Posted (Estimate)

August 23, 2007

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 9, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BAP00731

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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