臨床研究等提出・公開システム

Scientific Title	Exploratory analyses of biomarkers in blood and stratum corneum in patients with atopic dermatitis
Public Title	Exploratory analyses of biomarkers in blood and stratum corneum in patients with atopic dermatitis

Contact for Scientific Queries	Name	Tamagawa-Mineoka Risa
	Affiliation	Kyoto Prefectural University of Medicine
	Address	465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto
	Telephone	+81-75-251-5586
	E-mail	risat@koto.kpu-m.ac.jp
Contact for Public Queries	Name	Tamagawa-Mineoka Risa
	Affiliation	Kyoto Prefectural University of Medicine
	Address	465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto
	Telephone	+81-75-251-5586
	E-mail	risat@koto.kpu-m.ac.jp

Recruitment status	Complete

Anticipated date of first enrollment		Feb. 11, 2022
Actual date of first enrollment		Feb. 21, 2022
Target sample size		15
Study Type		Observational
Study Design	allocation
	masking
	control
	assignment
	purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1) Patients who were diagnosed as atopic dermatitis following the criteria of the Japanese Dermatological Association by dermatologists, Persons who is generally judged as healthy. 2) Persons who can give voluntary written consent to participate in the present trial
	Exclusion Criteria	1) Patients with skin infection. 2) Patients who were orally administered immunosuppressant within 4 weeks prior to the study.
	Age Minimum	20age old over
	Age Maximum	80age old under
	Gender	Male
Health Condition(s) or Problem(s) Studied		Atopic dermatitis
Intervention(s)
Health Condition(s) Keyword		Atopic dermatitis
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		To identify biomarkers associated with disease severity and activity of atopic dermatitis.
Secondary Outcome(s)		To quantify the candidates of biomarkers in protein level.

Primary Sponsor	Kyoto Prefectural University of Medicine

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support	Maruho Co., Ltd.
Secondary Sponsor	Not applicable

Name of Certified Review Board	Kyoto Prefectural University of Medicine, Ethical Review Board
Address	465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, Kyoto
Telephone	+81-75-251-5337
E-Mail	rinri@koto.kpu-m.ac.jp
Approval Status	Approval
Date of approval	Oct. 04, 2021

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

List of change history