A Study of Crisaborole Ointment 2% in Children Aged 3-24 Months With Mild to Moderate Atopic Dermatitis

Pfizer

Status and phase

Completed

Phase 4

Conditions

Atopic Dermatitis

Treatments

Drug: Crisaborole ointment 2%

Study type

Interventional

Funder types

Industry

Identifiers

NCT03356977

C3291002

CARE 1 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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).

Enrollment

137 patients

Sex

All

Ages

3 to 23 months old

Volunteers

No Healthy Volunteers

Inclusion criteria

Aged ≥ 3 months at the screening visit to < 24 months on baseline/Day 1, diagnosed with AD

Exclusion criteria

Subjects with any clinically significant dermatological condition or disease (including active or potentially recurrent non-AD dermatological conditions that overlap with AD such as Netherton Syndrome)