Clinical trial NCT03356977: A Study of Crisaborole Ointment 2% in Children Aged 3-24 Months With Mild to Moderate Atopic Dermatitis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atopic Dermatitis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2017-11-29
Enrollment: 137
Sex: ALL
Minimum age (years): 3
Maximum age (years): 23
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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).

Eligibility criteria: 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)

Primary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Site Reactions
timeFrame: Baseline (Day 1) up to at least 28 days after last dose of investigational product (up to 60 days)
measure: Number of Participants With Clinically Significant Height Values Meeting Pre-defined Criteria
timeFrame: Baseline (Day 1) up to Day 29 (end of treatment)
measure: Number of Participants With Clinically Significant Weight Values Meeting Pre-defined Criteria
timeFrame: Baseline (Day 1) up to Day 29 (end of treatment)
measure: Number of Participants With Clinically Significant Blood Pressure Values Meeting Pre-defined Criteria
timeFrame: Baseline (Day 1) up to Day 29 (end of treatment)
measure: Number of Participants With Clinically Significant Pulse Rate Values Meeting Pre-defined Criteria
timeFrame: Baseline (Day 1) up to Day 29 (end of treatment)
measure: Number of Participants With Clinically Significant Respiratory Rate Values Meeting Pre-defined Criteria
timeFrame: Baseline (Day 1) up to Day 29 (end of treatment)
measure: Number of Participants With Clinically Significant Body Temperature Values Meeting Pre-defined Criteria
timeFrame: Baseline (Day 1) up to Day 29 (end of treatment)
measure: Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Values Meeting Pre-defined Criteria
timeFrame: Baseline (Day 1) up to Day 29 (end of treatment)
measure: Number of Participants With Clinically Significant Laboratory Parameters Meeting Pre-defined Criteria
timeFrame: Baseline (Day 1) up to Day 29 (end of treatment)
Secondary outcomes:
Other outcomes:
Locations:
city: Hot Springs
country: United States
facility: Burke Pharmaceutical Research
state: Arkansas
city: San Diego
country: United States
facility: Rady Children's Hospital - San Diego/University of California, San Diego
state: California
city: San Diego
country: United States
facility: Rady Children's Hospital
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Thornton
country: United States
facility: IMMUNOe Research Centers
state: Colorado
city: Miami
country: United States
facility: Baumann Cosmetic and Research Institute
state: Florida
city: Louisville
country: United States
facility: DS Research
state: Kentucky
city: Bridgeton
country: United States
facility: Craig A. Spiegel, M.D.
state: Missouri
city: Omaha
country: United States
facility: Skin Specialists, PC
state: Nebraska
city: Dayton
country: United States
facility: Ohio Pediatric Research Association, Inc.
state: Ohio
city: Tulsa
country: United States
facility: Oklahoma State University - Center for Health Sciences
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Hershey
country: United States
facility: Penn State Hershey Medical Center
state: Pennsylvania
city: Austin
country: United States
facility: DermResearch, Inc.
state: Texas
city: San Antonio
country: United States
facility: Texas Dermatology and Laser Specialists
state: Texas
city: Layton
country: United States
facility: Tanner Clinic
state: Utah
city: West Jordan
country: United States
facility: Jordan Valley Dermatology Center
state: Utah
city: South Burlington
country: United States
facility: Timber Lane Allergy & Asthma Research, LLC
state: Vermont
city: Burke
country: United States
facility: PI-Coor Clinical Research, LLC
state: Virginia
city: Charlottesville
country: United States
facility: Pediatric Associates of Charlottesville, PLC
state: Virginia
city: Charlottesville
country: United States
facility: Pediatric Research of Charlottesville, LLC (Regulatory Only)
state: Virginia
city: Charlottesville
country: United States
facility: Pediatric Research of Charlottesville, LLC
state: Virginia
city: Spokane
country: United States
facility: Dermatology Specialists of Spokane
state: Washington
city: Maroubra
country: Australia
facility: Australian Clinical Research Network Pty Ltd
state: New South Wales
city: Benowa
country: Australia
facility: The Skin Centre
state: Queensland
city: Woolloongabba
country: Australia
facility: Veracity Clinical Research
state: Queensland
city: Box Hill
country: Australia
facility: Eastern Health
state: Victoria
city: East Melbourne
country: Australia
facility: Sinclair Dermatology
state: Victoria
city: Parkville
country: Australia
facility: The Royal Children's Hospital
state: Victoria
city: Edmonton
country: Canada
facility: Stollery Children's Hospital
state: Alberta
city: Markham
country: Canada
facility: Lynderm Research Inc.
state: Ontario
city: Peterborough
country: Canada
facility: SKiN Centre for Dermatology
state: Ontario
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.