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A Study of the Long-Term Safety of Crisaborole Ointment, 2% in Japanese Pediatric and Adult Participants With Mild to Moderate Atopic Dermatitis

Primary Purpose

Atopic Dermatitis

Status
Terminated
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Crisaborole 2%
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring Eczema, Crisaborole

Eligibility Criteria

7 Months - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female participants;
  • Who were patients with mild to moderate AD aged 2 years old or older and met eligibility criteria for study C3291032 at the time when entering Study C3291032, and completed treatment period in Study C3291032 without safety issues. Or
  • Who were patients with mild to moderate AD aged 1 months to <24 months and met eligibility criteria for Study C3291031 at the time when entering Study C3291031, and completed treatment period in Study C3291031 without safety issues

Exclusion Criteria:

  • Has other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.

Sites / Locations

  • Shirao Clinic of Pediatrics and Pediatric Allergy
  • Chitose dermatology and plastic surgery clinic
  • Takagi Dermatological Clinic
  • Yoshimura Child Clinic
  • Iryouhoujinshadan Yamayurikai Tsujino. Kodomo Clinic
  • Noguchi Dermatology Clinic
  • Yoshioka Dermatology Clinic
  • Mildix Skin Clinic
  • Yoga Allergy Clinic
  • Sugamo Kobayashi Derma Clinic
  • Hoshikuma Dermatology・Allergy Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Crisaborole 2%

Arm Description

Crisaborole 2% ointment applied twice daily (BID)

Outcomes

Primary Outcome Measures

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
An adverse events (AE) is any untoward medical occurrence in clinical investigation participant administered a product or medical device; event need not necessarily to had a causal relationship with treatment or usage. SAEs: an AE resulting in any of following outcomes/deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs are events between first dose of study drug and up to 28 days after last dose of study drug, that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.

Secondary Outcome Measures

Full Information

First Posted
July 31, 2020
Last Updated
July 20, 2021
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT04498403
Brief Title
A Study of the Long-Term Safety of Crisaborole Ointment, 2% in Japanese Pediatric and Adult Participants With Mild to Moderate Atopic Dermatitis
Official Title
A PHASE 3, MULTICENTER, OPEN-LABEL STUDY OF THE LONG-TERM SAFETY OF CRISABOROLE OINTMENT, 2% IN JAPANESE PEDIATRIC AND ADULT PARTICIPANTS WITH MILD TO MODERATE ATOPIC DERMATITIS
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Terminated
Why Stopped
Terminated (This decision was made for business reasons only and is not related to any safety concerns regarding crisaborole.)
Study Start Date
September 14, 2020 (Actual)
Primary Completion Date
December 18, 2020 (Actual)
Study Completion Date
December 18, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study is a Phase 3, multicenter, open-label, long-term safety extension study of Studies C3291032 and C3291031 in Japanese pediatric and adult participants with mild to moderate Atopic Dermatitis (AD).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Eczema, Crisaborole

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Crisaborole 2%
Arm Type
Experimental
Arm Description
Crisaborole 2% ointment applied twice daily (BID)
Intervention Type
Drug
Intervention Name(s)
Crisaborole 2%
Intervention Description
Crisaborole 2% ointment
Primary Outcome Measure Information:
Title
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Description
An adverse events (AE) is any untoward medical occurrence in clinical investigation participant administered a product or medical device; event need not necessarily to had a causal relationship with treatment or usage. SAEs: an AE resulting in any of following outcomes/deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs are events between first dose of study drug and up to 28 days after last dose of study drug, that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.
Time Frame
Baseline up to 28 days after last dose of study drug (maximum up to 12 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female participants; Who were patients with mild to moderate AD aged 2 years old or older and met eligibility criteria for study C3291032 at the time when entering Study C3291032, and completed treatment period in Study C3291032 without safety issues. Or Who were patients with mild to moderate AD aged 1 months to <24 months and met eligibility criteria for Study C3291031 at the time when entering Study C3291031, and completed treatment period in Study C3291031 without safety issues Exclusion Criteria: Has other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Shirao Clinic of Pediatrics and Pediatric Allergy
City
Hiroshima-shi
State/Province
Hiroshima
ZIP/Postal Code
734-0023
Country
Japan
Facility Name
Chitose dermatology and plastic surgery clinic
City
Chitose Shi
State/Province
Hokkaido
ZIP/Postal Code
066-0021
Country
Japan
Facility Name
Takagi Dermatological Clinic
City
Obihiro
State/Province
Hokkaido
ZIP/Postal Code
080-0013
Country
Japan
Facility Name
Yoshimura Child Clinic
City
Akashi-City
State/Province
Hyōgo
ZIP/Postal Code
674-0068
Country
Japan
Facility Name
Iryouhoujinshadan Yamayurikai Tsujino. Kodomo Clinic
City
Kobe-City
State/Province
Hyōgo
ZIP/Postal Code
658-0082
Country
Japan
Facility Name
Noguchi Dermatology Clinic
City
Kamimashiki-gun
State/Province
Kumamoto
ZIP/Postal Code
861-3101
Country
Japan
Facility Name
Yoshioka Dermatology Clinic
City
Neyagawa
State/Province
Osaka
ZIP/Postal Code
572-0838
Country
Japan
Facility Name
Mildix Skin Clinic
City
Adachi-ku
State/Province
Tokyo
ZIP/Postal Code
120-0034
Country
Japan
Facility Name
Yoga Allergy Clinic
City
Setagaya-ku
State/Province
Tokyo
ZIP/Postal Code
158-0097
Country
Japan
Facility Name
Sugamo Kobayashi Derma Clinic
City
Toshima-Ku
State/Province
Tokyo
ZIP/Postal Code
170-0002
Country
Japan
Facility Name
Hoshikuma Dermatology・Allergy Clinic
City
Fukuoka
ZIP/Postal Code
814-0171
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=C3291027
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

A Study of the Long-Term Safety of Crisaborole Ointment, 2% in Japanese Pediatric and Adult Participants With Mild to Moderate Atopic Dermatitis

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