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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Stiefel, a GSK Company

Current Primary Outcome: Response as assessed by Physicans Global Assessment (PGA) [ Time Frame: 24 weeks (end-of treatment) ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Patients Global Assessment (PaGA) [ Time Frame: 24 weeks (end-of-treatment) ]
  • Modified Total Lesion Symptom Score (mTLSS) [ Time Frame: 24 weeks (end-of treatment) ]
  • Extent of disease [ Time Frame: 24 weeks (end-of treatment) ]
  • Adverse events, laboratory tests [ Time Frame: continuosly during treatment ]
  • Psychiatric questionaires (BSI-53, GHQ-9) [ Time Frame: continously during treatment ]
  • Bone densitometry and bone x-rays [ Time Frame: 24 weeks (end-of treatment), follow-up 48 weeks post treatment ]
  • Ophthalmologic evaluation [ Time Frame: 24 weeks (end of treatment) ]
  • Audiologic evaluation [ Time Frame: 24 weeks (end-of-treatment) ]


Original Secondary Outcome: Same as current

Information By: GlaxoSmithKline

Dates:
Date Received: January 5, 2009
Date Started: January 2009
Date Completion:
Last Updated: April 18, 2013
Last Verified: March 2013