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



Status:Recruiting
Conditions:Psoriasis, Dermatology, Dermatology, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:Any
Updated:4/6/2019
Start Date:January 16, 2018
End Date:April 12, 2019
Contact:Pfizer CT.gov Call Center
Email:ClinicalTrials.gov_Inquiries@pfizer.com
Phone:1-800-718-1021

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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).

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)
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Austin, Texas 78759
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Bridgeton, Missouri 63044
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Burke, Virginia 22015
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1011 East Jefferson Street
Charlottesville, Virginia 22902
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Charlottesville, Virginia 22902
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Hershey, Pennsylvania 17033
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Hot Springs, Arkansas 71913
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Layton, Utah 84041
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Louisville, Kentucky 40202
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Maroubra, New South Wales 2035
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Omaha, Nebraska 68144
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Orange, California 92868
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San Antonio, Texas 78218
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3020 Children's Way
San Diego, California 92123
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San Francisco, California 94143
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53 Timber Lane
South Burlington, Vermont 05403
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510 South Cowley Street
Spokane, Washington 99202
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3260 East 104th Avenue
Thornton, Colorado 80233
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West Jordan, Utah 84088
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