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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
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
Secondary ID [1] 0 0
CARE 1
Secondary ID [2] 0 0
C3291002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Baseline (Day 1) up to at least 28 days after last dose of investigational product (up to 60 days)
Primary outcome [2] 0 0
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.
Timepoint [2] 0 0
Baseline (Day 1) up to Day 29 (end of treatment)
Primary outcome [3] 0 0
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.
Timepoint [3] 0 0
Baseline (Day 1) up to Day 29 (end of treatment)
Primary outcome [4] 0 0
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.
Timepoint [4] 0 0
Baseline (Day 1) up to Day 29 (end of treatment)
Primary outcome [5] 0 0
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.
Timepoint [5] 0 0
Baseline (Day 1) up to Day 29 (end of treatment)
Primary outcome [6] 0 0
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.
Timepoint [6] 0 0
Baseline (Day 1) up to Day 29 (end of treatment)
Primary outcome [7] 0 0
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.
Timepoint [7] 0 0
Baseline (Day 1) up to Day 29 (end of treatment)
Primary outcome [8] 0 0
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.
Timepoint [8] 0 0
Baseline (Day 1) up to Day 29 (end of treatment)
Primary outcome [9] 0 0
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.
Timepoint [9] 0 0
Baseline (Day 1) up to Day 29 (end of treatment)

Eligibility
Key inclusion criteria
Aged = 3 months at the screening visit to < 24 months on baseline/Day 1, diagnosed with AD
Minimum age
3 Months
Maximum age
23 Months
Gender
Both males and females
Can healthy volunteers participate?
No
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)

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Australian Clinical Research Network Pty Ltd - Maroubra
Recruitment hospital [2] 0 0
The Skin Centre - Benowa
Recruitment hospital [3] 0 0
Veracity Clinical Research - Woolloongabba
Recruitment hospital [4] 0 0
Eastern Health - Box Hill
Recruitment hospital [5] 0 0
Sinclair Dermatology - East Melbourne
Recruitment hospital [6] 0 0
The Royal Children's Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2035 - Maroubra
Recruitment postcode(s) [2] 0 0
4217 - Benowa
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
3128 - Box Hill
Recruitment postcode(s) [5] 0 0
3002 - East Melbourne
Recruitment postcode(s) [6] 0 0
3052 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Kentucky
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
Nebraska
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
United States of America
State/province [9] 0 0
Oklahoma
Country [10] 0 0
United States of America
State/province [10] 0 0
Oregon
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
United States of America
State/province [13] 0 0
Utah
Country [14] 0 0
United States of America
State/province [14] 0 0
Vermont
Country [15] 0 0
United States of America
State/province [15] 0 0
Virginia
Country [16] 0 0
United States of America
State/province [16] 0 0
Washington
Country [17] 0 0
Canada
State/province [17] 0 0
Alberta
Country [18] 0 0
Canada
State/province [18] 0 0
Ontario

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT03356977
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications