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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03356977
Registration number
NCT03356977
Ethics application status
Date submitted
31/10/2017
Date registered
29/11/2017
Date last updated
10/10/2019
Titles & IDs
Public title
A Study of Crisaborole Ointment 2% in Children Aged 3-24 Months With Mild to Moderate Atopic Dermatitis
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Scientific 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
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Secondary ID [1]
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CARE 1
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Secondary ID [2]
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C3291002
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis
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Condition category
Condition code
Skin
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Dermatological conditions
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Skin
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Other skin conditions
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Crisaborole ointment 2%
Experimental: Crisaborole ointment 2% - Subjects will be dosed for 28 days. A thin layer of ointment will be applied to all areas designated for treatment.
Treatment: Drugs: Crisaborole ointment 2%
Applied BID
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Site Reactions
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline (Day 1) up to at least 28 days after last dose of investigational product (up to 60 days)
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Primary outcome [2]
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Number of Participants With Clinically Significant Height Values Meeting Pre-defined Criteria
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline (Day 1) up to Day 29 (end of treatment)
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Primary outcome [3]
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Number of Participants With Clinically Significant Weight Values Meeting Pre-defined Criteria
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline (Day 1) up to Day 29 (end of treatment)
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Primary outcome [4]
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Number of Participants With Clinically Significant Blood Pressure Values Meeting Pre-defined Criteria
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Assessment method [4]
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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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Timepoint [4]
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Baseline (Day 1) up to Day 29 (end of treatment)
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Primary outcome [5]
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Number of Participants With Clinically Significant Pulse Rate Values Meeting Pre-defined Criteria
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Assessment method [5]
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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.
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Timepoint [5]
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Baseline (Day 1) up to Day 29 (end of treatment)
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Primary outcome [6]
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Number of Participants With Clinically Significant Respiratory Rate Values Meeting Pre-defined Criteria
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Assessment method [6]
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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.
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Timepoint [6]
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Baseline (Day 1) up to Day 29 (end of treatment)
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Primary outcome [7]
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Number of Participants With Clinically Significant Body Temperature Values Meeting Pre-defined Criteria
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Assessment method [7]
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Body temperature of participants was measured in degree Celsius. The normal body temperature value was >= 39 degree Celsius.
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Timepoint [7]
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Baseline (Day 1) up to Day 29 (end of treatment)
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Primary outcome [8]
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Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Values Meeting Pre-defined Criteria
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Assessment method [8]
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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.
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Timepoint [8]
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Baseline (Day 1) up to Day 29 (end of treatment)
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Primary outcome [9]
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Number of Participants With Clinically Significant Laboratory Parameters Meeting Pre-defined Criteria
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Assessment method [9]
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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.
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Timepoint [9]
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Baseline (Day 1) up to Day 29 (end of treatment)
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Eligibility
Key inclusion criteria
Aged = 3 months at the screening visit to < 24 months on baseline/Day 1, diagnosed with AD
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Minimum age
3
Months
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Maximum age
23
Months
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
16/01/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
12/04/2019
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Sample size
Target
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Accrual to date
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Final
137
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Australian Clinical Research Network Pty Ltd - Maroubra
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Recruitment hospital [2]
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The Skin Centre - Benowa
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Recruitment hospital [3]
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Veracity Clinical Research - Woolloongabba
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Recruitment hospital [4]
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Eastern Health - Box Hill
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Recruitment hospital [5]
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Sinclair Dermatology - East Melbourne
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Recruitment hospital [6]
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The Royal Children's Hospital - Parkville
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Recruitment postcode(s) [1]
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2035 - Maroubra
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Recruitment postcode(s) [2]
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4217 - Benowa
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Recruitment postcode(s) [3]
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4102 - Woolloongabba
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Recruitment postcode(s) [4]
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3128 - Box Hill
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Recruitment postcode(s) [5]
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3002 - East Melbourne
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Recruitment postcode(s) [6]
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3052 - Parkville
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arkansas
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United States of America
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State/province [2]
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California
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Country [3]
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United States of America
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State/province [3]
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Colorado
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Country [4]
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United States of America
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State/province [4]
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Florida
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Country [5]
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United States of America
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State/province [5]
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Kentucky
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Country [6]
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United States of America
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State/province [6]
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Missouri
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Country [7]
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United States of America
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State/province [7]
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Nebraska
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Country [8]
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United States of America
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State/province [8]
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Ohio
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Country [9]
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United States of America
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State/province [9]
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Oklahoma
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Country [10]
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United States of America
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State/province [10]
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Oregon
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Country [11]
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United States of America
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State/province [11]
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Pennsylvania
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Country [12]
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United States of America
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State/province [12]
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Texas
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Country [13]
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State/province [13]
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Utah
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Country [14]
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State/province [14]
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Vermont
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Country [15]
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United States of America
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State/province [15]
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Virginia
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Country [16]
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United States of America
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State/province [16]
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Washington
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Country [17]
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Canada
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State/province [17]
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Alberta
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Country [18]
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Canada
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State/province [18]
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Ontario
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Pfizer
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03356977
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Pfizer CT.gov Call Center
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Address
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Pfizer
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03356977
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