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