臨床研究等提出・公開システム

Date of registration	Aug. 06, 2024
Last modified on	Aug. 06, 2024
Trial ID	jRCT1030240253

Scientific Title	Stratum corneum sampling study for validation of analytical method for drug concentration in human stratum corneum
Public Title	Stratum corneum sampling study for validation of analytical method for drug concentration in human stratum corneum

Contact for Scientific Queries	Name	Takazawa Kenji
	Affiliation	Medical Corporation Shinanokai Shinanozaka Clinic
	Address	3F Yotsuya Medical Building, 20 Samoncho, Shinjuku-ku, Tokyo
	Telephone	+81-3-5366-3006
	E-mail	m-kinomoto@trcp.co.jp
Contact for Public Queries	Name	Kinomoto Mikito
	Affiliation	Tokyo Research Center of Clinical Pharmacology Co., Ltd.
	Address	Yotsuya Medical Building, 20 Samoncho, Shinjuku-ku, Tokyo
	Telephone	+81-3-5366-3006
	E-mail	m-kinomoto@trcp.co.jp

Recruitment status	Pending

Anticipated date of first enrollment		July. 29, 2024
Target sample size		6
Study Type		Observational
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	(1) Age: 20 to 40 years old (at the time of obtaining consent) (2) Persons whose BMI [Body Mass Index: weight (kg) / height (mm)2] is 18.5 kg/m2 or more and less than 25 kg/m2 (numbers are not rounded).
	Exclusion Criteria	Persons with have skin wounds at the site of stratum corneum collection, and those who have skin symptoms such as eczema, contact dermatitis, psoriasis, seborrheic dermatitis, dyschromatosis, and excessive sunburn at the site of stratum corneum collection.
	Age Minimum	20age old over
	Age Maximum	40age old under
	Gender	Male
Health Condition(s) or Problem(s) Studied		Pain relief and anti-inflammation
Primary Outcome(s)		Stratum corneum sampling TEWL measurement value
Secondary Outcome(s)		none

Primary Sponsor	Lead Chemical Co., Ltd.

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Medical Corporation Shinanokai Shinanozaka Clinic Ethics Committee
Address	Yotsuya Medical Building, 20 Samoncho, Shinjuku-ku, Tokyo, Tokyo
Telephone	+81-3-5366-3006
E-Mail	scl-irb@shinanokai.com
Approval Status	Approval
Date of approval	July. 23, 2024

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none