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 |
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.
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).
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)
We found this trial at
25
sites
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
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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1011 East Jefferson Street
Charlottesville, Virginia 22902
Charlottesville, Virginia 22902
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3020 Children's Way
San Diego, California 92123
San Diego, California 92123
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