This is a multi-center, open-label trial to evaluate safety and pharmacokinetics of topical delgocitinib cream applied to pediatric subjects (2-17 years) and adult subjects (18 years and above) with atopic dermatitis.
A phase 1 open-label, multi-centre, single-arm trial to evaluate the safety and pharmacokinetics (including MUsT) of twice daily topical application of delgocitinib cream for 8 weeks in adults, adolescents, and children with moderate to severe atopic dermatitis
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
46
Cream for topical application
LEO Pharma investigational site
Birmingham, Alabama, United States
LEO Pharma investigational site
Phoenix, Arizona, United States
Adverse events (AEs)
Number of AEs and number of subjects with AEs
Time frame: Week 0 to Week 8
PK parameter - Cmax
Cmax
Time frame: at Day 8
PK parameter - AUC
AUC
Time frame: at Day 8
PK parameter - tmax
tmax
Time frame: at Day 8
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LEO Pharma investigational site
Fountain Valley, California, United States
LEO Pharma investigational site
Irvine, California, United States
LEO Pharma investigational site
Los Angeles, California, United States
LEO Pharma investigational site
Centennial, Colorado, United States
LEO Pharma investigational site
New Haven, Connecticut, United States
LEO Pharma investigational site
Indianapolis, Indiana, United States
LEO Pharma investigational site
Ypsilanti, Michigan, United States
LEO Pharma investigational site
Tulsa, Oklahoma, United States
...and 6 more locations