A Study of Crisaborole Ointment 2% in Children Aged 3-24 Months With Mild to Moderate Atopic Dermatitis

Atopic Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03356977
• Other study ID #: C3291002
• Secondary ID: CARE 1
• Status: Completed
• Phase: Phase 4
• Start date: January 16, 2018
• Est. completion date: April 12, 2019

Study information

• Verified date: September 2019
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: April 12, 2019
• Est. primary completion date: April 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 23 Months

Eligibility

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)

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Crisaborole ointment 2%
Applied BID

Locations

Country	Name	City	State
Australia	The Skin Centre	Benowa	Queensland
Australia	Eastern Health	Box Hill	Victoria
Australia	Sinclair Dermatology	East Melbourne	Victoria
Australia	Australian Clinical Research Network Pty Ltd	Maroubra	New South Wales
Australia	The Royal Children's Hospital	Parkville	Victoria
Australia	Veracity Clinical Research	Woolloongabba	Queensland
Canada	Stollery Children's Hospital	Edmonton	Alberta
Canada	Lynderm Research Inc.	Markham	Ontario
Canada	SKiN Centre for Dermatology	Peterborough	Ontario
United States	DermResearch, Inc.	Austin	Texas
United States	Craig A. Spiegel, M.D.	Bridgeton	Missouri
United States	PI-Coor Clinical Research, LLC	Burke	Virginia
United States	Pediatric Associates of Charlottesville, PLC	Charlottesville	Virginia
United States	Pediatric Research of Charlottesville, LLC	Charlottesville	Virginia
United States	Pediatric Research of Charlottesville, LLC (Regulatory Only)	Charlottesville	Virginia
United States	Ohio Pediatric Research Association, Inc.	Dayton	Ohio
United States	Penn State Hershey Medical Center	Hershey	Pennsylvania
United States	Burke Pharmaceutical Research	Hot Springs	Arkansas
United States	Tanner Clinic	Layton	Utah
United States	DS Research	Louisville	Kentucky
United States	Baumann Cosmetic and Research Institute	Miami	Florida
United States	Skin Specialists, PC	Omaha	Nebraska
United States	Oregon Health & Science University	Portland	Oregon
United States	Texas Dermatology and Laser Specialists	San Antonio	Texas
United States	Rady Children's Hospital	San Diego	California
United States	Rady Children's Hospital - San Diego/University of California, San Diego	San Diego	California
United States	University of California, San Francisco	San Francisco	California
United States	Timber Lane Allergy & Asthma Research, LLC	South Burlington	Vermont
United States	Dermatology Specialists of Spokane	Spokane	Washington
United States	IMMUNOe Research Centers	Thornton	Colorado
United States	Oklahoma State University - Center for Health Sciences	Tulsa	Oklahoma
United States	Jordan Valley Dermatology Center	West Jordan	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline (Day 1) up to at least 28 days after last dose of investigational product (up to 60 days)
Primary	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.	Baseline (Day 1) up to Day 29 (end of treatment)
Primary	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.	Baseline (Day 1) up to Day 29 (end of treatment)
Primary	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.	Baseline (Day 1) up to Day 29 (end of treatment)
Primary	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.	Baseline (Day 1) up to Day 29 (end of treatment)
Primary	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.	Baseline (Day 1) up to Day 29 (end of treatment)
Primary	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.	Baseline (Day 1) up to Day 29 (end of treatment)
Primary	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.	Baseline (Day 1) up to Day 29 (end of treatment)
Primary	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.	Baseline (Day 1) up to Day 29 (end of treatment)

External Links

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