臨床研究等提出・公開システム

Date of registration	Jan. 27, 2025
Last modified on	Mar. 31, 2026
Trial ID	jRCT2011240068

Scientific Title	A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of SR-0379 in Participants with Skin Ulcer (SR0379-JP-SU-02)
Public Title	A Phase 3 Study of SR-0379 in Participants with Skin Ulcer (SR0379-JP-SU-02)

Contact for Scientific Queries	Name	Tomioka Hideki
	Affiliation	FunPep Co., Ltd.
	Address	Office for University-Industry Collaboration Bldg. A, 5F No.509, Osaka University 2-1 Yamadaoka, Suita, Osaka
	Telephone	+81-6-6369-7957
	E-mail	htomioka@funpep.co.jp
Contact for Public Queries	Name	Kasahara Satoru
	Affiliation	FunPep Co., Ltd.
	Address	Office for University-Industry Collaboration Bldg. A, 5F No.509, Osaka University 2-1 Yamadaoka, Suita, Osaka
	Telephone	+81-6-6369-7957
	E-mail	skasahara@funpep.co.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Mar. 01, 2025
Actual date of first enrollment		Mar. 18, 2025
Target sample size		142
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Patients with a skin ulcer requiring wound bed preparation before surgical intervention (sutures, skin grafts or pedicle flaps)
	Exclusion Criteria	Patients with obvious infection at the ulcer site, such as redness or swelling around the ulcer, pus, foul odor, or fever
	Age Minimum	18age old over
	Age Maximum	85age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		skin ulcer
Intervention(s)		SR-0379 or placebo spray
Primary Outcome(s)		Days to minor surgical intervention (sutures, skin grafts or pedicle flaps)

Primary Sponsor	FunPep Co., Ltd.

Name of Certified Review Board	Hakodate Central General Hospital Institutional Review Board
Address	33-2, Hon-cho, Hakodate-city, Hokkaido, Hokkaido
Telephone	+81-138-52-1231
E-Mail	kubota-y@hakochu-hp.gr.jp
Approval Status	Approval
Date of approval	Jan. 14, 2025

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
5	Mar. 31, 2026	(this page)	Changes
4	Jan. 09, 2026	Detail	Changes
3	April. 10, 2025	Detail	Changes
2	Mar. 17, 2025	Detail	Changes
1	Jan. 27, 2025	Detail

List of change history