Alitretinoin in the Treatment of Chronic Hand Eczema

Phase 3

Completed

• Conditions: Eczema

• Registration Number: NCT00519675
• Lead Sponsor: Basilea Pharmaceutica

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 Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-08-22
• Study First Submitted QC: 2007-08-22
• Study First Posted: 2007-08-23
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-09
• Last Update Posted: 2023-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Safety assessments

Secondary Outcome Measures

Name	Time	Method
Efficacy (Physicians Global Assessment)