臨床研究等提出・公開システム

Date of registration	Feb. 08, 2024
Last modified on	July. 30, 2024
Trial ID	jRCT2031230626

Scientific Title	A Phase I, skin safety study with SKE-18 1% cream in healthy Japanese participants
Public Title	A Phase I, skin safety study with SKE-18 1% cream in healthy Japanese participants

Contact for Scientific Queries	Name	Kasumi Sanpei
	Affiliation	Sato Pharmaceutical Co., Ltd.
	Address	1-5-27, Motoakasaka, Minato-Ku, Tokyo
	Telephone	+81-3-5412-7329
	E-mail	clinicaltrials-info@sato-seiyaku.co.jp
Contact for Public Queries	Name	Clinical Trials Information Desk
	Affiliation	Sato Pharmaceutical Co., Ltd.
	Address	1-5-27, Motoakasaka, Minato-Ku, Tokyo
	Telephone	+81-3-5412-7329
	E-mail	clinicaltrials-info@sato-seiyaku.co.jp

Recruitment status	Complete

Anticipated date of first enrollment		April. 01, 2024
Actual date of first enrollment		Mar. 28, 2024
Target sample size		25
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	single blind
	control	placebo control
	assignment	parallel assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	1. Healthy Japanese adult males aged 18 to 40 years at the time of signing the Informed Consent Form 2. Subjects with BMI (body mass index) of >= 18.5 to < 25.0 at screening 3. Subjects who are considered by the investigator as acceptable for inclusion in the study as judged from the results of observation and inspection upon screening and admission 4. Subjects who received full explanations regarding the objective of the study, details of the study and the study drug and provided voluntary written informed consent
	Exclusion Criteria	1. Subject with a medical history of drug allergy 2. Subjects with a medical history of food allergy 3. Subjects with a medical history (heart, liver, kidney, lung, blood diseases, etc.) that is considered ineligible for the study 4. Subjects with a medical history of contact dermatitis, such as adhesive tape dermatitis, or mechanical urticaria 5. Subjects with a medical history of photosensitivity 6. Subjects considered ineligible for the study by the investigator
	Age Minimum	18age old over
	Age Maximum	40age old under
	Gender	Male
Health Condition(s) or Problem(s) Studied		Rosacea
Intervention(s)		SKE-18, vehicle, and white petrolatum are applied.
Primary Outcome(s)		Safety

Primary Sponsor	Sato Pharmaceutical Co., Ltd.

Name of Certified Review Board	Medical Corporation Shinanokai Shinanozaka Clinic Institutional Review Board
Address	Yotsuya Medical-building, 20 Samoncho, Shinjuku-Ku, Tokyo
Telephone	+81-3-5366-3006
E-Mail	scl-irb@shinanokai.com
Approval Status	Approval
Date of approval	Mar. 12, 2024

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
4	July. 30, 2024	(this page)	Changes
3	May. 07, 2024	Detail	Changes
2	April. 03, 2024	Detail	Changes
1	Feb. 08, 2024	Detail

List of change history