Atopic Dermatitis Clinical Trial
Official title:
A PHASE 4, MULTICENTER, OPEN-LABEL SAFETY STUDY OF CRISABOROLE OINTMENT 2% IN CHILDREN AGED 3 MONTHS TO LESS THAN 24 MONTHS WITH MILD TO MODERATE ATOPIC DERMATITIS
This 4-week study will evaluate the safety, pharmacokinetics (PK), and efficacy of crisaborole ointment 2%, applied twice daily (BID) in subjects who are 3 months to less than 24 months of age with mild-to-moderate AD.
Approximately 125 subjects will be enrolled. Subjects must have mild-to-moderate AD involving
at least 5% treatable %BSA assessed on Baseline/Day 1. Treatable %BSA will be defined as the
percent of a subject's total body surface area that is AD-involved, excluding the scalp.
In addition, a cohort of at least 16 of the 125 subjects will be included in a subgroup for
PK assessment. These subjects must have moderate AD and a minimum of 35% treatable %BSA,
excluding the scalp, and must complete all PK assessments to be included in the PK analysis.
Of these subjects, at least 3 subjects who are less than 9 months of age will be enrolled.
Subjects discontinuing for reasons other than treatment emergent adverse event ( TEAE) may be
replaced at the discretion of the sponsor to ensure 16 subjects complete the PK assessments.
Only selected study sites will participate in the PK assessment.
Scheduled study visits/telephone contacts for all subjects will occur at Screening (up to 28
days prior to Baseline/Day 1), Baseline/Day 1, Day 8, Day 15, Day 22, Day 29 (end of
treatment/early termination), Day 36, and Day 57 (end of study).
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