NCT00817063

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

Efficacy and Safety of Alitretinoin in the Treatment of Severe Chronic Hand Eczema Refractory to Topical Therapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 599 (actual)
• Sponsor: Stiefel, a GSK Company · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Eczema

Interventions

Type	Name	Description
DRUG	alitretinoin	Patients receive alitretinoin 30mg one capsule daily for up to 24 weeks
DRUG	Placebo	Patients receive matching placebo for up to 24 weeks

Timeline

• Start date: 2009-01-08
• Primary completion: 2012-04-26
• Completion: 2012-04-26
• First posted: 2009-01-06
• Last updated: 2020-04-27
• Results posted: 2017-11-09

Locations

70 sites across 1 country: United States