Alitretinoin in the Treatment of Chronic Hand Eczema

This study has been completed.
Sponsor:
Information provided by:
Basilea Pharmaceutica
ClinicalTrials.gov Identifier:
NCT00519675
First received: August 22, 2007
Last updated: July 16, 2010
Last verified: July 2010
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

ClinicalTrials.gov Identifier: NCT00519675     History of Changes
Other Study ID Numbers: BAP00731
Study First Received: August 22, 2007
Last Updated: July 16, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
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:
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Eczematous
Alitretinoin
Tretinoin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Keratolytic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on July 23, 2014