A Study of Crisaborole Ointment 2% in Children Aged 3-24 Months With Mild to Moderate Atopic Dermatitis
NCT ID: NCT03356977
Last Updated: 2019-10-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
137 participants
INTERVENTIONAL
2018-01-16
2019-04-12
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Crisaborole ointment 2%
Subjects will be dosed for 28 days. A thin layer of ointment will be applied to all areas designated for treatment.
Crisaborole ointment 2%
Applied BID
Interventions
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Crisaborole ointment 2%
Applied BID
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
3 Months
23 Months
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Burke Pharmaceutical Research
Hot Springs, Arkansas, United States
Rady Children's Hospital - San Diego/University of California, San Diego
San Diego, California, United States
Rady Children's Hospital
San Diego, California, United States
University of California, San Francisco
San Francisco, California, United States
IMMUNOe Research Centers
Thornton, Colorado, United States
Baumann Cosmetic and Research Institute
Miami, Florida, United States
DS Research
Louisville, Kentucky, United States
Craig A. Spiegel, M.D.
Bridgeton, Missouri, United States
Skin Specialists, PC
Omaha, Nebraska, United States
Ohio Pediatric Research Association, Inc.
Dayton, Ohio, United States
Oklahoma State University - Center for Health Sciences
Tulsa, Oklahoma, United States
Oregon Health & Science University
Portland, Oregon, United States
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States
DermResearch, Inc.
Austin, Texas, United States
Texas Dermatology and Laser Specialists
San Antonio, Texas, United States
Tanner Clinic
Layton, Utah, United States
Jordan Valley Dermatology Center
West Jordan, Utah, United States
Timber Lane Allergy & Asthma Research, LLC
South Burlington, Vermont, United States
PI-Coor Clinical Research, LLC
Burke, Virginia, United States
Pediatric Associates of Charlottesville, PLC
Charlottesville, Virginia, United States
Pediatric Research of Charlottesville, LLC (Regulatory Only)
Charlottesville, Virginia, United States
Pediatric Research of Charlottesville, LLC
Charlottesville, Virginia, United States
Dermatology Specialists of Spokane
Spokane, Washington, United States
Australian Clinical Research Network Pty Ltd
Maroubra, New South Wales, Australia
The Skin Centre
Benowa, Queensland, Australia
Veracity Clinical Research
Woolloongabba, Queensland, Australia
Eastern Health
Box Hill, Victoria, Australia
Sinclair Dermatology
East Melbourne, Victoria, Australia
The Royal Children's Hospital
Parkville, Victoria, Australia
Stollery Children's Hospital
Edmonton, Alberta, Canada
Lynderm Research Inc.
Markham, Ontario, Canada
SKiN Centre for Dermatology
Peterborough, Ontario, Canada
Countries
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References
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Schlessinger J, Shepard JS, Gower R, Su JC, Lynde C, Cha A, Ports WC, Purohit V, Takiya L, Werth JL, Zang C, Vlahos B; CARE 1 Investigators. Safety, Effectiveness, and Pharmacokinetics of Crisaborole in Infants Aged 3 to < 24 Months with Mild-to-Moderate Atopic Dermatitis: A Phase IV Open-Label Study (CrisADe CARE 1). Am J Clin Dermatol. 2020 Apr;21(2):275-284. doi: 10.1007/s40257-020-00510-6.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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CARE 1
Identifier Type: OTHER
Identifier Source: secondary_id
C3291002
Identifier Type: -
Identifier Source: org_study_id
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