Alitretinoin in the Treatment of Chronic Hand Eczema

Phase 3CompletedNCT00519675

Basilea Pharmaceutica150 enrolled

Overview

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

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

150

Conditions

Eczema

Interventions

alitretinoinDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (4)

Unnamed facility

Paris, France

Unnamed facility

Saint-Etienne, France

Unnamed facility

Berlin, Germany

Unnamed facility

Dresden, Germany

Outcomes

Primary Outcomes

Safety assessments

Secondary Outcomes

Efficacy (Physicians Global Assessment)

Data from ClinicalTrials.gov

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