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

NCT03356977 | Completed Phase 4 Results DMC FDA Drug

• 2 other identifiers: C3291002CARE 1
• Study Type: interventional
• Target: 137
• Locations: 3 countries
• Sites: 32

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.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (9)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

Study Arms (1)

Crisaborole ointment 2%

EXPERIMENTAL

Subjects will be dosed for 28 days. A thin layer of ointment will be applied to all areas designated for treatment.

Drug: Crisaborole ointment 2%

Interventions

Crisaborole ointment 2% DRUG

Applied BID

Also known as: Eucrisa

Crisaborole ointment 2%

Eligibility Criteria

• Age: 3 Months - 23 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Aged ≥ 3 months at the screening visit to \< 24 months on baseline/Day 1, diagnosed with AD

You may not qualify if:

• 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)

Sponsors & Collaborators

• Pfizer: lead

Study Sites (32)

Burke Pharmaceutical Research

Hot Springs, Arkansas, 71913, United States

Location

Rady Children's Hospital - San Diego/University of California, San Diego

San Diego, California, 92123, United States

Location

Rady Children's Hospital

San Diego, California, 92123, United States

Location

University of California, San Francisco

San Francisco, California, 94115, United States

Location

IMMUNOe Research Centers

Thornton, Colorado, 80233, United States

Location

Baumann Cosmetic and Research Institute

Miami, Florida, 33137, United States

Location

DS Research

Louisville, Kentucky, 40241, United States

Location

Craig A. Spiegel, M.D.

Bridgeton, Missouri, 63044, United States

Location

Skin Specialists, PC

Omaha, Nebraska, 68144, United States

Location

Ohio Pediatric Research Association, Inc.

Dayton, Ohio, 45414, United States

Location

Oklahoma State University - Center for Health Sciences

Tulsa, Oklahoma, 74127, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

DermResearch, Inc.

Austin, Texas, 78759, United States

Location

Texas Dermatology and Laser Specialists

San Antonio, Texas, 78218, United States

Location

Tanner Clinic

Layton, Utah, 84041, United States

Location

Jordan Valley Dermatology Center

West Jordan, Utah, 84088, United States

Location

Timber Lane Allergy & Asthma Research, LLC

South Burlington, Vermont, 05403, United States

Location

PI-Coor Clinical Research, LLC

Burke, Virginia, 22015, United States

Location

Pediatric Associates of Charlottesville, PLC

Charlottesville, Virginia, 22902, United States

Location

Pediatric Research of Charlottesville, LLC (Regulatory Only)

Charlottesville, Virginia, 22902, United States

Location

Pediatric Research of Charlottesville, LLC

Charlottesville, Virginia, 22902, United States

Location

Dermatology Specialists of Spokane

Spokane, Washington, 99202, United States

Location

Australian Clinical Research Network Pty Ltd

Maroubra, New South Wales, 2035, Australia

Location

The Skin Centre

Benowa, Queensland, 4217, Australia

Location

Veracity Clinical Research

Woolloongabba, Queensland, 4102, Australia

Location

Eastern Health

Box Hill, Victoria, 3128, Australia

Location

Sinclair Dermatology

East Melbourne, Victoria, 3002, Australia

Location

The Royal Children's Hospital

Parkville, Victoria, 3052, Australia

Location

Stollery Children's Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

Lynderm Research Inc.

Markham, Ontario, L3P 1X2, Canada

Location

SKiN Centre for Dermatology

Peterborough, Ontario, K9J 5K2, Canada

Location

Related Publications (1)

• Schlessinger J, Shepard JS, Gower R, Su JC, Lynde C, Cha A, Ports WC, Purohit V, Takiya L, Werth JL, Zang C, Vlahos B; CARE 1 Investigators. Safety, Effectiveness, and Pharmacokinetics of Crisaborole in Infants Aged 3 to < 24 Months with Mild-to-Moderate Atopic Dermatitis: A Phase IV Open-Label Study (CrisADe CARE 1). Am J Clin Dermatol. 2020 Apr;21(2):275-284. doi: 10.1007/s40257-020-00510-6.

  PMID: 32212104 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

crisaborole

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2017
• First Posted: November 29, 2017
• Study Start: January 16, 2018
• Primary Completion: April 12, 2019
• Study Completion: April 12, 2019
• Last Updated: October 10, 2019
• Results First Posted: October 10, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share

Locations

US (23); AU (6); CA (3)