Efficacy and Safety of a Retinoid for the Treatment of Severe Chronic Hand Dermatitis

Basilea Pharmaceutica1,035 enrolled

Overview

The purpose of the study is to determine the therapeutic effect of alitretinoin, a retinoid, on severe, therapy refractory chronic hand dermatitis.

Chronic hand dermatitis (CHaD) is a frequent and distressing disease. Conventional treatments yield mostly unsatisfactory results. In addition, chronic hand dermatitis leads to 2-5% of all applications for permanent disability pensions in some western countries. In a therapeutic dose finding study alitretinoin was clinically effective for patients with moderate to severe chronic hand dermatitis refractory to topical treatment. Patients with severe refractory CHaD will be allocated either of two active treatments or placebo. The primary objective is to demonstrate the response rate based on physicians global assessment of the disease.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,035

Conditions

Hand Dermatoses

Interventions

alitretinoinDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Chronic hand dermatitis, all types including hyperkeratotic, vesicular, fingertip dermatitis * Lasting for 6 months since initial diagnosis * Rated severe * Refractory to standard therapy including non-medicated therapy and avoidance of irritants and allergens * Refractory to topical steroids Exclusion Criteria: * Female patients who are pregnant or want to become pregnant * Female patients of child bearing potential who cannot use or will not commit to using two effective forms of contraception simultaneously * Patients whose disease is adequately controlled by standard non-medicated therapy and standard corticosteroid therapy

Locations (1)

Thomas Ruzicka, MD

Düsseldorf, Germany

Outcomes

Primary Outcomes

Physicians global assessment

at week 12 or 24

Secondary Outcomes

Response rate per treatment group

Modified total lesion symptom score

Patients global assessment

at week 12 or 24

Time to relapse

Data from ClinicalTrials.gov

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