The purpose of the trial is to test how much delgocitinib enters the body over a given time period after application of delgocitinib cream in patients with moderate to severe hand eczema. Delgocitinib is a cream that suppresses specific processes in the body's response to diseases like CHE, such as inflammation. Everyone in the trial will use delgocitinib cream. The trial will last up to 7 weeks and there will be 6 visits and a phone call. There will be a screening period of up to 4 weeks, a treatment period (with blood sampling) of 11 days and a safety follow-up phone call 11 days after the last visit.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Cream for topical application 20 mg/g
LEO Investigational Site
Hamburg, Germany
Area under the concentration-time curve 0-12 hours post dose at Day 1 and Day 8 (AUC0-12).
Time frame: 0-12 hours post dose at Day 1 and Day 8
Maximum observed concentration (Cmax) at Day 1 and at Day 8 (0-12 hours post-dose).
Time frame: Day 1 and at Day 8 (0-12 hours post-dose)
Time to reach maximum observed concentration (tmax) at Day 1 and Day 8 (0-12 hours post-dose).
Time frame: Day 1 and Day 8 (0-12 hours post-dose).
Terminal elimination half-life (t1/2) at Day 8.
Time frame: Day 8.
Number of treatment-emergent adverse events (AEs) from baseline to Day 22 per subject.
Time frame: Baseline to Day 22
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