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

Efficacy and Safety of BAL4079 in the Treatment of Severe Refractory Chronic Hand Dermatitis

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00124475

Enrollment

1035

Registered

2005-07-28

Start date

2004-12-31

Completion date

2007-09-30

Last updated

2023-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hand Dermatoses

Keywords

Chronic Hand Dermatitis

Brief summary

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

Detailed description

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.

Interventions

DRUGalitretinoin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Physicians global assessment	—
at week 12 or 24	—

Secondary

Measure	Time frame
Patients global assessment	—
Response rate per treatment group	—
Time to relapse	—
at week 12 or 24	—
Modified total lesion symptom score	—

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026