臨床研究等提出・公開システム

Scientific Title	Phase I Clinical Study of JTE-052 new drug product - Dermal Safety Study -
Public Title	Dermal Safety Study of JTE-052

Completion date	May. 15, 2024
Result actual enrolment	22
Baseline Characteristics	The mean age (SD) was 25.40 (+-6.6) years.
Participant flow	The individual investigational products (JTE-052 new drug product and its placebo) and the negative control (non-application) were applied to 22 subjects. All subjects completed the study.
Adverse events	Three adverse events (AEs) were reported in 2 subjects (9.1%).
Outcome measures	The skin irritation index was 0.0 for investigational products (JTE-052 new drug product and its placebo) and the negative control (non-application).
Brief summary	There were no significant safety concerns of JTE-052 new drug product for skin.
Date of posting of results summaries
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD	No
Plan description
URL link to protocol file(s) with version and date	https://jrct.mhlw.go.jp/latest-detail/jRCT2031230570

Contact for Scientific Queries	Name	Koretomo Ryosuke
	Affiliation	Shionogi & Co.,Ltd.
	Address	3-4-1, Nihonbashi-Honcho, Chuo-ku, Tokyo, Japan
	Telephone	+81-3-6635-3505
	E-mail	clinicaltrials-info@shionogi.co.jp
Contact for Public Queries	Name	clinical trials information
	Affiliation	Shionogi & Co.,Ltd.
	Address	3-4-1, Nihonbashi-Honcho , Chuo-ku, Tokyo, Japan
	Telephone	+81-3-6635-3505
	E-mail	clinicaltrials-info@shionogi.co.jp

Recruitment status	Complete

Anticipated date of first enrollment		Feb. 14, 2024
Actual date of first enrollment		Feb. 19, 2024
Target sample size		22
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	single blind
	control	placebo control
	assignment	single assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	1.Healthy Japanese males aged from 20 to 45 years 2.Those with a body mass index (BMI) of 18.5 to less than 25.0
	Exclusion Criteria	1.Those who have skin conditions that may affect the evaluation in the study, e.g., eczema, dermatitis, pigmentation abnormality, inflammation caused by sunburn, injury, scar, and excessive hair growth, at the prospective application site 2.Those who have a history of contact dermatitis caused by dermatological drugs, adhesive plaster, tape, etc. mechanical urticaria, dermal hypersensitivity, or atopic dermatitis 3.Those to whom JTE-052 has been administered in the past 4.Those for whom the investigator judged it problematic to participate in the study
	Age Minimum	20age old over
	Age Maximum	45age old under
	Gender	Male
Health Condition(s) or Problem(s) Studied		atopic dermatitis
Intervention(s)		Single application of JTE-052 0.5%
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Potential for skin irritation
Secondary Outcome(s)

Primary Sponsor	Japan Tobacco Inc.

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

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

Name of Certified Review Board	Medical Corporation Shinanokai Shinanozaka Clinic Institutional Review Board
Address	20 Samoncho, Shinjuku-ku, Tokyo
Telephone	+81-3-5366-3006
E-Mail	scl-irb@shinanokai.com
Approval Status	Approval
Date of approval	Feb. 13, 2024

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

List of change history