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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
137
Applied BID
Number of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Site Reactions
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.
Time frame: Baseline (Day 1) up to at least 28 days after last dose of investigational product (up to 60 days)
Number of Participants With Clinically Significant Height Values Meeting Pre-defined Criteria
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.
Time frame: Baseline (Day 1) up to Day 29 (end of treatment)
Number of Participants With Clinically Significant Weight Values Meeting Pre-defined Criteria
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.
Time frame: Baseline (Day 1) up to Day 29 (end of treatment)
Number of Participants With Clinically Significant Blood Pressure Values Meeting Pre-defined Criteria
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.
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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
...and 22 more locations
Time frame: Baseline (Day 1) up to Day 29 (end of treatment)
Number of Participants With Clinically Significant Pulse Rate Values Meeting Pre-defined Criteria
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.
Time frame: Baseline (Day 1) up to Day 29 (end of treatment)
Number of Participants With Clinically Significant Respiratory Rate Values Meeting Pre-defined Criteria
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.
Time frame: Baseline (Day 1) up to Day 29 (end of treatment)
Number of Participants With Clinically Significant Body Temperature Values Meeting Pre-defined Criteria
Body temperature of participants was measured in degree Celsius. The normal body temperature value was \>= 39 degree Celsius.
Time frame: Baseline (Day 1) up to Day 29 (end of treatment)
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Values Meeting Pre-defined Criteria
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.
Time frame: Baseline (Day 1) up to Day 29 (end of treatment)
Number of Participants With Clinically Significant Laboratory Parameters Meeting Pre-defined Criteria
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.
Time frame: Baseline (Day 1) up to Day 29 (end of treatment)