Conditions: Eczema
Keywords: retinoid treatment fingertip dermatitis hyperkeratotic hand eczema vesicular hand eczema pompholyx
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 599
Healthy volunteers: no

Brief 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.

Detailed description:
Chronic hand eczema (CHE)is a distressing disease that poses difficult problems for dermatologists. CHE leads to considerable work-absenteeism, disability and exclusion from labour market. Conventional treatments, including highly potent topical steroids, yield often unsatisfactory results. This study investigates the efficacy and safety of oral alitretinoin, a retinoid, in patients who have not responded to avoidance of causative factors, such as contact allergens and skin irritants, non-medicated skin care and highly potent topical steroids. Eligible patients are randomly assigned to receive alitretinoin or a placebo.

Arms:
arm 1: Patients will receive alitretinoin 30mg capsule for up to 24 weeks arm 2: Patients will receive placebo 30mg capsule for up to 24 weeks

Interventions: intervention 1: alitretinoin intervention 2: Placebo
Intervention descriptions: intervention 1: Patients receive alitretinoin 30mg one capsule daily for up to 24 weeks intervention 2: Patients receive matching placebo for up to 24 weeks

Protocol document: