A Study of Crisaborole Ointment 2% in Children Aged 3-24 Months With Mild to Moderate Atopic Dermatitis
- Registration Number
- NCT03356977
- Lead Sponsor
- Pfizer
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 137
Aged ≥ 3 months at the screening visit to < 24 months on baseline/Day 1, diagnosed with AD
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Crisaborole ointment 2% Crisaborole ointment 2% Subjects will be dosed for 28 days. A thin layer of ointment will be applied to all areas designated for treatment.
- Primary Outcome Measures
Name Time Method Number of Participants With Clinically Significant Body Temperature Values Meeting Pre-defined Criteria Baseline (Day 1) up to Day 29 (end of treatment) Body temperature of participants was measured in degree Celsius. The normal body temperature value was \>= 39 degree Celsius.
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Values Meeting Pre-defined Criteria Baseline (Day 1) up to Day 29 (end of treatment) ECG of participants was measured in terms of millisecond (msec). ECG parameters included pulse rate (PR) interval, QRS interval, corrected QT interval using Fridericia's formula (QTcF). ECG values meeting pre-defined criteria were 1) PR interval: greater than equal to (\>=) 25 percent (%) increase when baseline greater than (\>)200 milliseconds (msec); or increase \>=50% when baseline less than or equal to (\<=200) msec; 2) QRS interval: \>=25% increase when baseline \>100 msec; \>=50% increase when baseline \<= 100 msec; 3) QTCF interval: QTc interval using Fridericia's formula (QTcF interval) \> 30 msec. IFB stands for increase from baseline.
Number of Participants With Clinically Significant Laboratory Parameters Meeting Pre-defined Criteria Baseline (Day 1) up to Day 29 (end of treatment) Criteria: hematology: hemoglobin, hematocrit, erythrocytes \< 0.8\*lower limit of normal (LLN), platelets \<0.5\*LLN \>1.75\*upper limit of normal (ULN), leukocytes \<0.6\* LLN \>1.5\* ULN, lymphocytes, lymphocytes/leukocytes, neutrophils, neutrophils/leukocytes \<0.8\* LLN \>1.2\* ULN, basophils, basophils/leukocytes, eosinophils, eosinophils/leukocytes monocytes monocytes/leukocytes \>1.2\*ULN. Clinical chemistry: bilirubin \>1.5\*ULN, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase \>3.0\*ULN, protein, albumin \<0.8\* LLN \>1.2\* ULN, blood urea nitrogen, creatinine \>1.3\* ULN, sodium \<0.95\*LLN \>1.05\*ULN, potassium, chloride, bicarbonate \<0.9\* LLN \>1.1\* ULN, glucose \<0.6\*LLN \>1.5\*ULN.
Number of Participants With Clinically Significant Height Values Meeting Pre-defined Criteria Baseline (Day 1) up to Day 29 (end of treatment) Height of participants was measured in terms of centimeter (cm). The pre-defined criteria for measuring the height was less than (\<) 55 cm and greater than (\>) 92.5 cm.
Number of Participants With Clinically Significant Weight Values Meeting Pre-defined Criteria Baseline (Day 1) up to Day 29 (end of treatment) Weight of participants was measured in terms of kilogram (kg). The pre-defined criteria of measuring the weight of participants was less than equal to (\<=) 4.5 kg and \>15 kg.
Number of Participants With Clinically Significant Respiratory Rate Values Meeting Pre-defined Criteria Baseline (Day 1) up to Day 29 (end of treatment) Respiratory rate was measured in terms of number of breaths per minute. The pre-defined criteria of measuring the respiratory rate of participants was \< 22 breaths per min and \> 53 breaths per min.
Number of Participants With Clinically Significant Blood Pressure Values Meeting Pre-defined Criteria Baseline (Day 1) up to Day 29 (end of treatment) Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) of participants was measured in terms of millimeters of mercury (mmHg). The clinically significant pre-defined criteria were, SBP: change of greater than equal to (\>=) 30 mmHg increase from baseline (IFB) and SBP change of \>= 30 mmHg decrease from baseline (DFB); DBP: change of \>=20 mmHg IFB and DBP change of \>=20 mmHg DFB.
Number of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Site Reactions Baseline (Day 1) up to at least 28 days after last dose of investigational product (up to 60 days) An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. Treatment-emergent were events between first dose of investigational product and up to 28 days after the last dose of investigational product that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs. Site reactions are reactions which occurred in participants at the site of application of investigational product.
Number of Participants With Clinically Significant Pulse Rate Values Meeting Pre-defined Criteria Baseline (Day 1) up to Day 29 (end of treatment) Pulse rate of participants was measured in terms of beats per minute (bpm). The pre-defined criteria of measuring the pulse rate of participants was \<90 bpm and \>180 bpm.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (32)
Penn State Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Baumann Cosmetic and Research Institute
🇺🇸Miami, Florida, United States
Texas Dermatology and Laser Specialists
🇺🇸San Antonio, Texas, United States
The Skin Centre
🇦🇺Benowa, Queensland, Australia
Ohio Pediatric Research Association, Inc.
🇺🇸Dayton, Ohio, United States
Oklahoma State University - Center for Health Sciences
🇺🇸Tulsa, Oklahoma, United States
Pediatric Research of Charlottesville, LLC (Regulatory Only)
🇺🇸Charlottesville, Virginia, United States
Pediatric Research of Charlottesville, LLC
🇺🇸Charlottesville, Virginia, United States
Eastern Health
🇦🇺Box Hill, Victoria, Australia
Stollery Children's Hospital
🇨🇦Edmonton, Alberta, Canada
SKiN Centre for Dermatology
🇨🇦Peterborough, Ontario, Canada
Lynderm Research Inc.
🇨🇦Markham, Ontario, Canada
Craig A. Spiegel, M.D.
🇺🇸Bridgeton, Missouri, United States
Dermatology Specialists of Spokane
🇺🇸Spokane, Washington, United States
DermResearch, Inc.
🇺🇸Austin, Texas, United States
Jordan Valley Dermatology Center
🇺🇸West Jordan, Utah, United States
Sinclair Dermatology
🇦🇺East Melbourne, Victoria, Australia
The Royal Children's Hospital
🇦🇺Parkville, Victoria, Australia
Veracity Clinical Research
🇦🇺Woolloongabba, Queensland, Australia
Pediatric Associates of Charlottesville, PLC
🇺🇸Charlottesville, Virginia, United States
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
IMMUNOe Research Centers
🇺🇸Thornton, Colorado, United States
DS Research
🇺🇸Louisville, Kentucky, United States
Tanner Clinic
🇺🇸Layton, Utah, United States
Timber Lane Allergy & Asthma Research, LLC
🇺🇸South Burlington, Vermont, United States
PI-Coor Clinical Research, LLC
🇺🇸Burke, Virginia, United States
Australian Clinical Research Network Pty Ltd
🇦🇺Maroubra, New South Wales, Australia
University of California, San Francisco
🇺🇸San Francisco, California, United States
Skin Specialists, PC
🇺🇸Omaha, Nebraska, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States