Efficacy and Safety of a Retinoid in the Treatment of Severe Chronic Hand Eczema (HANDEL)
Efficacy and Safety of a Retinoid in the Treatment of Severe Chronic Hand Eczema (HANDEL)
ClinicalTrials.gov ID: NCT00817063
Sponsor: Stiefel, a GSK Company
Information provided by: GlaxoSmithKline (Stiefel, a GSK Company) (Responsible Party)
Last Update Posted: 2020-04-27
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.
Official Title:
Efficacy and Safety of Alitretinoin in the Treatment of Severe Chronic Hand Eczema Refractory to Topical Therapy
Intervention / Treatment:
- Drug: alitretinoin
- Drug: Placebo
| Category | Value |
|---|---|
| Study Start (Actual) | 2009-01-08 |
| Primary Completion (Actual) | 2012-04-26 |
| Study Completion (Actual) | 2012-04-26 |
| Enrollment (Actual) | 599 |
| Study Type | Interventional |
| Phase | Phase 3 |
| Other Study ID Numbers |
117183
BAP01346 (Other Identifier) (OTHER: Basilea Pharmaceutica) NCT00817063 (Registry Identifier) (REGISTRY: Clinicaltrials.gov) |