The purpose of this study is to evaluate the safety, tolerability and the pharmacokinetics (PK) of topical ruxolitinib cream applied to pediatric subjects (age ≥ 2 to 17 years) with atopic dermatitis (AD).
Study has been modified to include younger pediatric subjects (age ≥2 to 11) in four additional cohorts.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Ruxolitinib phosphate cream at the protocol-defined dose strength based on cohort assignment.
Cahaba Dermatology
Hoover, Alabama, United States
Participants with treatment-emergent adverse events (TEAEs)
A TEAE is any adverse event (AE) either reported for the first time or worsening of a pre-existing event after first application of study drug.
Time frame: Screening through 30-37 days after end of treatment, up to approximately 12 weeks.
Plasma concentrations of ruxolitinib for Cohorts 1 and 2
Venous blood samples will be collected to assess the PK of ruxolitinib .
Time frame: Day 1, Day 15, and Day 29
Plasma concentrations of ruxolitinib for Cohorts 3, 4, 5 and 6
Venous blood samples will be collected to assess the PK of ruxolitinib .
Time frame: Day 1, Day 10, and Day 29
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