Efficacy and Safety of a Retinoid in the Treatment of Severe Chronic Hand Eczema

• Status: Completed
• Trial end date: 2012-04-26
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate the safety and efficacy of alitretinoin in the treatment of severe chronic hand eczema that does not respond to treatment with potent topical steroids.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stiefel, a GSK Company
• Collaborator: Basilea Pharmaceutica
• Treatments: Alitretinoin; Tretinoin

Criteria

Inclusion Criteria:

• all types of chronic hand eczema, lasting for at least 6 months since initial diagnosis

• rated as severe by the physician

• unresponsive to highly potent topical corticosteroids, such as clobetasol

Exclusion Criteria:

• patients whose disease is adequately controlled by standard non-medicated therapy, including potent topical steroids, skin moisturizers, and avoidance of allergens and irritants

• patients with known allergens and irritants, who have not made a reasonable effort to avoid the substances

• patients with psoriasis lesions

• active fungal, bacterial or viral infections of the hands

• female patients who are pregnant or breastfeeding

• female patients of childbearing potential who cannot use or will not commit to use two effective methods of contraception