Alitretinoin in the Treatment of Chronic Hand Eczema

• Sponsor: Basilea Pharmaceutica (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00519675
• Collaborator: (none)
• Enrollment: 150
• Locations: 4
• Patients Per Site: 37.5

Study Details

Study Description

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 150 participants
• Allocation: N/A
• 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 1, 2007

Outcome Measures

Primary Outcome Measures

1. Safety assessments []

Secondary Outcome Measures

1. Efficacy (Physicians Global Assessment) []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1		Paris		France
2		Saint Etienne		France
3		Berlin		Germany
4		Dresden		Germany

Sponsors and Collaborators

• Basilea Pharmaceutica

Investigators

• Study Director: Jürgen Maares, MD, Basilea Pharmaceutica

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00519675
• Other Study ID Numbers: BAP00731
• First Posted: Aug 23, 2007
• Last Update Posted: Jul 19, 2010
• Last Verified: Jul 1, 2010

• Keywords provided by , ,: Chronic hand eczema; Chronic hand dermatitis; Patients with chronic hand eczema, who are refractory to topical corticosteroids
• Additional relevant MeSH terms: Eczema; Alitretinoin

Study Results

No Results Posted as of Jul 19, 2010