臨床研究等提出・公開システム

Date of registration	Aug. 30, 2017
Last modified on	Nov. 22, 2021
Trial ID	jRCT2080223634

Scientific Title	-
Public Title	-

Completion Date or Terminated date	Nov. 27, 2017
Actual Enrolled Number	32
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results	Oct. 27, 2019
URL hyperlink(s) related to results and publications	https://doi.org/10.1111/1346-8138.15123

Plan to share IPD	No
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	-
	Address	-
	Phone Number
	E-mail Address	clinical-trials@pfizer.com

Contact for Public Queries	Name
	Contact Name for Public Queries	-
	Address	-
	Phone Number
	E-mail Address	clinical-trials@pfizer.com

Recruitment Status	completed

Date of First Enrolment		Sept. 13, 2017
Target Sample Size		32
Study Type		Interventional
Study Design	Study Design	-
Study Design	Objective	other
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	-
	Exclusion Criteria	-
	Minimum Age	20age old over
	Maximum Age	55age old under
	Gender	Both
Health Condition or Problem Studied		-
Intervention(s)		investigational material(s) Generic name etc : - INN of investigational material : crisaborole Therapeutic category code : 269 Other agents for epidermis Dosage and Administration for Investigational material : - control material(s) Generic name etc : - INN of investigational material : - Therapeutic category code : --- Other Dosage and Administration for Investigational material : -
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		safety -
Secondary Outcome		pharmacokinetics -

Primary Sponsor	-
Secondary Sponsor	-

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB	-
Address of IRB	-
Phone Number of IRB	-
E-mail Address of IRB	-
Status of IRB Review	approved
Date of Approval by IRB	Aug. 03, 2017

Secondary ID No.	NCT03260595
Name of Other Registries	ClinicalTrials.gov

Secondary ID No.	JapicCTI-173690
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
4	Nov. 22, 2021	(this page)	Changes
3	Feb. 02, 2018	Detail	Changes
2	Nov. 07, 2017	Detail	Changes
1	Aug. 30, 2017	Detail

List of change history