Clinical Trial: Alitretinoin vs Azathioprine in Severe Non-hyperkeratotic Hand Eczema
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Efficacy of Oral Alitretinoin Versus Oral Azathioprine in Patients With Severe Chronic Non-hyperkeratotic Hand Eczema. A Randomized Prospective Open-label Trial With Blind
Brief Summary: The purpose of this study is to compare the efficacy of alitretinoin and azathioprine in the treatment of patients with severe chronic non-hyperkeratotic hand eczema.
Detailed Summary:
Sponsor: University Medical Center Groningen
Current Primary Outcome: Response to treatment/hand eczema severity (Photoguide) [ Time Frame: 24 weeks (end of treatment) ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Response to treatment/hand eczema severity (Photoguide) [ Time Frame: 12 weeks ]
- Response to treatment/hand eczema severity (Hand Eczema Severity Index, HECSI) [ Time Frame: Week 4, 8, 12, 24 ]
- Time to response [ Time Frame: Week 4, 8, 12, 24 ]
- Patient reported improvement (Patient Global Assessment, PaGA) [ Time Frame: Week 12 and 24 ]
- Safety and tolerability (adverse events) [ Time Frame: Up to 24 weeks ]
- Cost-utility. QALY's: registered direct/indirect costs, combined with EQ-5D outcome [ Time Frame: Week 12 and 24 ]
- Cost-effectiveness: registered direct/indirect costs combined with the primary and secondary effectiveness outcomes (Photoguide/HECSI) [ Time Frame: Week 12 and 24 ]
- Quality of Life: questionnaire. [ Time Frame: Week 12 and 24 ]
Original Secondary Outcome: Same as current
Information By: University Medical Center Groningen
Dates:
Date Received: August 18, 2016
Date Started: May 2016
Date Completion: December 2018
Last Updated: January 18, 2017
Last Verified: January 2017