Summary

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

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

  • University of California, San Francisco accepting new patients
    San Francisco California 94115 United States
  • Cummins, Kozak, Gillman & Ellis, Inc not yet accepting patients
    Orange California 92868 United States

Lead Scientist

  • Sarah Arron
    My research focuses on the pathogenesis of cutaneous squamous cell carcinoma. As a Mohs Micrographic surgeon in the department of Dermatology, I lead the High Risk Skin Cancer Program, a practice devoted to the care of patients at risk for skin cancer due to solid organ transplant and other iatrogenic immunosuppression, HIV infection, and genetic conditions predisposing to cutaneous malignancy.

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