Last updated on December 2018

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


Brief description of study

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.

Detailed Study 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).

Clinical Study Identifier: NCT03356977

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Burke Pharmaceutical Research
Hot Springs, AR United States
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Cummins, Kozak, Gillman & Ellis, Inc
Orange, CA United States
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Rady Children's Hospital - San Diego/University of California, San Diego
San Diego, CA United States
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University of California, San Francisco
San Francisco, CA United States
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IMMUNOe Research Centers
Thornton, CO United States
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DS Research
Louisville, KY United States
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Craig A. Spiegel, M.D.
Bridgeton, MO United States
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Skin Specialists, PC
Omaha, NE United States
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Ohio Pediatric Research Association, Inc.
Dayton, OH United States
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Oklahoma State University - Center for Health Sciences
Tulsa, OK United States
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DermResearch, Inc.
Austin, TX United States
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Texas Dermatology and Laser Specialists
San Antonio, TX United States
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Tanner Clinic
Layton, UT United States
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Jordan Valley Dermatology Center
West Jordan, UT United States
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PI-Coor Clinical Research, LLC
Burke, VA United States
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Pediatric Associates of Charlottesville, PLC
Charlottesville, VA United States
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Pediatric Research of Charlottesville, LLC
Charlottesville, VA United States
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Clinical Research Partners, LLC
Richmond, VA United States
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Dermatology Specialists of Spokane
Spokane, WA United States
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Australian Clinical Research Network Pty Ltd
Maroubra, Australia
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The Skin Centre
Benowa, Australia
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Veracity Clinical Research
Woolloongabba, Australia
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Lynderm Research Inc.
Markham, ON Canada
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SKiN Centre for Dermatology
Peterborough, ON Canada
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The Royal Children's Hospital
Parkville, Australia
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Baumann Cosmetic and Research Institute
Miami, FL United States
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Penn State Hershey Medical Center
Hershey, PA United States
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The Pennsylvania State University & Milton S. Hershey Med Cnt
Hershey, PA United States
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Timber Lane Allergy & Asthma Research, LLC
South Burlington, VT United States
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Eastern Health
Box Hill, Australia
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Oregon Health & Science University
Portland, OR United States
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Centre hospitalier universitaire Sainte-Justine
Montreal, QC Canada
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Sinclair Dermatology
East Melborne, Australia
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Research Pharmacy Office
Edmonton, AB Canada
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Stollery Children's Hospital
Edmonton, AB Canada
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Recruitment Status: Open


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