Alitretinoin in the Treatment of Chronic Hand Eczema

NCT ID: NCT00519675

Last Updated: 2023-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31

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.

Conditions

Eczema

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

alitretinoin

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Basilea Pharmaceutica

INDUSTRY

Sponsor Role: lead

Principal Investigators

Jürgen Maares, MD

Role: STUDY_DIRECTOR

Basilea Pharmaceutica

Locations

Paris, , France

Saint-Etienne, , France

Berlin, , Germany

Dresden, , Germany

Countries

France; Germany

Other Identifiers

BAP00731

Identifier Type: -

Identifier Source: org_study_id