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

Phase 3

Completed

• Conditions: Hand Dermatoses

• Registration Number: NCT00309621
• Lead Sponsor: Basilea Pharmaceutica

Brief Summary

Patients with severe chronic hand dermatitis, that has not responded to topical treatment, including topical steroids and the avoidance of aggravating factors, will be treated with the oral medication alitretinoin. The study aims to investigate the safety and efficacy of the medication when given over a period of 6 months.

Detailed Description

For severe, chronic hand dermatitis, refractory to topical treatment and the avoidance of aggravating factors such as allergens and irritants, no registered systemic treatment is available. Current systemic treatment options consist in the off-label use of systemic immune suppressants, such as cyclosporine, methotrexate.

Severe chronic hand dermatitis is a debilitating disease, with massive impact on social life and working ability. A huge proportion of the population suffers for more than a decade, and job losses are a frequent consequence.

This open-label trial investigates the safety and efficacy of oral alitretinoin 30mg as a single daily dose for up to 6 months. The trial is complementary to the pivotal efficacy study BAP00089.

Study Timeline

• Study First Submitted: 2006-03-30
• Study First Submitted QC: 2006-03-30
• Study Start: 2006-04
• Study First Posted: 2006-04-03
• Primary Completion: 2007-04
• Study Completion: 2007-05
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-09
• Last Update Posted: 2023-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• Chronic hand dermatitis, rated as severe by physicians global assessment, present for at least 6 months, that has not responded to the avoidance of allergens and irritants and the use of topical steroids

Exclusion Criteria

• female of childbearing potential, unless participating in a pregnancy prevention program
• psoriasis
• active major psychiatric condition

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Safety Laboratory
Radiological investigations (bone density, x-ray)
Safety:
Adverse Events

Secondary Outcome Measures

Name	Time	Method
Physicians Global Assessment
modified Total Lesion Symptom Score
Patients Global Assessment
Patient Defined Outcomes

Trial Locations

Locations (1)

Abt. Klinische Sozialmedizin; 🇩🇪 Heidelberg, Germany