NCT03026907.

Trial name or 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
Methods	Randomised observer‐blind vehicle‐controlled parallel‐group study
Participants	116 patients with severe chronic non‐hyperkeratotic hand eczema Inclusion criteria ≥ 18 years and ≤ 75 years of age Severe or very severe chronic non‐hyperkeratotic hand eczema for a minimum duration of 3 months as defined by a Physician Global Assessment (PGA) using a validated Photoguide Refractory to standard therapy, defined as follows: patients received treatment with topical corticosteroids of class II or higher for at least 8 weeks within 3 months before enrolment, with no response or a transient response. Patients had also received standard skin care, including emollients and barrier protection as appropriate, without significant improvement. Patients had avoided irritants and allergens, if identified, without significant improvement Women of child‐bearing potential are required to use at least 2 forms of contraception for at least 1 month before starting treatment, during treatment, and for at least 1 month after finishing treatment; these women are required to take monthly pregnancy tests Able to provide written informed consent Able to speak and read the Dutch language Exclusion criteria Extensive list
Interventions	Intervention • Oral alitretinoin capsule of 30 mg once daily for a total of 24 weeks • Oral azathioprine tablets twice daily at a dose of 1.5 or 2.5 mg/kg/d, depending on thiopurine methyltransferase (TPMT) activity
Outcomes	Primary outcome of the trial Response to treatment/hand eczema severity (Photoguide) after 24 weeks (end of treatment) Secondary outcomes of the trial Response to treatment/hand eczema severity (Photoguide) after 12 weeks Response to treatment/hand eczema severity based on th Hand Eczema Severity Index (HECSI) at weeks 4, 8, 12, and 24 Time to response at weeks 4, 8, 12, and 24 Patient‐reported improvement based on the Patient Global Assessment (PaGA) at weeks 12 and 24 Adverse events up to 24 weeks Cost utility. QALYs: registered direct/indirect costs, combined with EQ‐5D outcome at weeks 12 and 24 Cost‐effectiveness: registered direct/indirect costs combined with primary and secondary effectiveness outcomes (Photoguide/HECSI) at weeks 12 and 24 Quality of life: questionnaire at weeks 12 and 24
Starting date	May 2016
Contact information	Marie‐Louise A. Schuttelaar, MD, PhD University Medical Center Groningen The Netherlands +31503612520 m.l.a.schuttelaar@umcg.nl
Notes	Sponsor: University Medical Center Groningen