Alitretinoin vs Azathioprine in Severe Non-hyperkeratotic Hand Eczema (ALIAZ)
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|ClinicalTrials.gov Identifier: NCT03026907|
Recruitment Status : Recruiting
First Posted : January 20, 2017
Last Update Posted : May 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hand Eczema||Drug: Alitretinoin Drug: Azathioprine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||116 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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 Blinded Outcome Assessment|
|Study Start Date :||May 2016|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
Active Comparator: Alitretinoin
Patients with severe chronic non-hyperkeratotic hand eczema, randomized to treatment with alitretinoin.
Oral alitretinoin capsule of 30mg once daily for a total of 24 weeks.
Active Comparator: Azathioprine
Patients with severe chronic non-hyperkeratotic hand eczema, randomized to treatment with azathioprine.
Oral azathioprine tablets twice daily in a dose of 1.5 or 2.5mg/kg/day, depending on the thiopurine methyltransferase (TPMT) activity.
- Response to treatment/hand eczema severity (Photoguide) [ Time Frame: 24 weeks (end of treatment) ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03026907
|Contact: MLA Schuttelaar, MD, PhDfirstname.lastname@example.org|
|Contact: JAF Oosterhaven, MDemail@example.com|
|University Medical Center Groningen||Recruiting|
|Groningen, Netherlands, 9700RB|
|Contact: MLA Schuttelaar, MD, PhD +31503612520 firstname.lastname@example.org|
|Contact: JAF Oosterhaven, MD +31503610795 email@example.com|
|Principal Investigator:||MLA Schuttelaar, MD, PhD||University Medical Center Groningen|