臨床研究等提出・公開システム

Date of registration	Nov. 19, 2021
Last modified on	Feb. 03, 2022
Trial ID	jRCT2031210434

Scientific Title	Skin Irritation and Phototoxicity Study of KX01 Ointment 1% in Japanese healthy male subjects
Public Title	Phase 1 study of KX01 Ointment 1% in Japanese healthy male subjects

Contact for Scientific Queries	Name	Kawase Hiroaki
	Affiliation	PharmaEssentia Japan KK
	Address	1-3-13 Motoakasaka, Minato-ku, Tokyo
	Telephone	+81-3-6910-5103
	E-mail	hiroaki_kawase@pharmaessentia.com
Contact for Public Queries	Name	Kawase Hiroaki
	Affiliation	PharmaEssentia Japan KK
	Address	1-3-13 Motoakasaka, Minato-ku, Tokyo
	Telephone	+81-3-6910-5103
	E-mail	hiroaki_kawase@pharmaessentia.com

Recruitment status	Complete

Anticipated date of first enrollment		Nov. 16, 2021
Actual date of first enrollment		Nov. 16, 2021
Target sample size		20
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	Healthy Japanese male adult, whose age 20-65 years old
	Exclusion Criteria	History of photosensitivity or photoallergy
	Age Minimum	20age old over
	Age Maximum	65age old under
	Gender	Male
Health Condition(s) or Problem(s) Studied		Actinic keratosis
Intervention(s)		Apply KX01 ointment 1%
Primary Outcome(s)		Safety, e.g. AE, evaluation

Primary Sponsor	PharmaEssentia Japan KK

Name of Certified Review Board	IRB of HOUEIKAI
Address	3-28-3 Ikebukuro, Toshima-ku, Tokyo
Telephone	+81-3-5396-4530
E-Mail	kanai_shinichiro@seri.co.jp
Approval Status	Approval
Date of approval	Oct. 14, 2021

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
3	Feb. 03, 2022	(this page)	Changes
2	Dec. 23, 2021	Detail	Changes
1	Nov. 19, 2021	Detail

List of change history