Summary

for people ages 3 months to 23 months (full criteria)
at San Diego, California and other locations
study started
estimated completion:

Description

Summary

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.

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

Details

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).

Keywords

Atopic Dermatitis Dermatitis Dermatitis, Atopic Eczema Crisaborole ointment 2%

Eligibility

You can join if…

Open to people ages 3 months to 23 months

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

You CAN'T join if...

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)

Locations

  • Rady Children's Hospital - San Diego/University of California, San Diego accepting new patients
    San Diego California 92123 United States
  • Cummins, Kozak, Gillman & Ellis, Inc not yet accepting patients
    Orange California 92868 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
Links
To obtain contact information for a study center near you, click here.
To obtain contact information for a study center near you, click here.
ID
NCT03356977
Phase
Phase 4
Study Type
Interventional
Last Updated