臨床研究等提出・公開システム

Scientific Title	he investigation of possible efficacy of topical anti-fungal agents to autoimmune vitiligo (he investigation of possible efficacy of topical anti-fungal agents to autoimmune vitiligo)
Public Title	The efficacy of topical anti-fungal agents to vitiligo (The efficacy of topical anti-fungal agents to vitiligo)

Completion date	Aug. 31, 2022
Result actual enrolment	14
Baseline Characteristics	Male 7 cases, female 7 cases (age 1-60 y.o, mean 27.2)
Participant flow	Total of 14 individuals were enrolled, no dropout was noted.
Adverse events	No adverse reaction was observed throughout the study.
Outcome measures	Perifollicular re-pigmentation was observed in one case, while no re-pigmentation was identified among 13 cases.
Brief summary	Topical anti-fungal agent was administered to total of 14 individuals with autoimmune vitiligo in this study. Perifollicular re-pigmentation was observed in one case, while no re-pigmentation was identified among 13 case.
Date of posting of results summaries	Jan. 01, 2023
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD	No
Plan description	None
URL link to protocol file(s) with version and date	https://jrct.mhlw.go.jp/latest-detail/jRCTs041180183

Contact for Scientific Queries	Name	Suzuki Tamio
	Affiliation	Yamagata University Faculty of Medicine
	Address	2-2-2 Iida-Nishi Yamagata, 990-9585 JAPAN
	Telephone	+81-23-628-5361
	E-mail	tamsuz@med.id.yamagata-u.ac.jp
Contact for Public Queries	Name	Suzuki Tamio
	Affiliation	Yamagata University Faculty of Medicine
	Address	2-2-2 Iida-Nishi Yamagata, 990-9585 JAPAN
	Telephone	+81-23-628-5361
	E-mail	tamsuz@med.id.yamagata-u.ac.jp

Recruitment status	Complete

Anticipated date of first enrollment		Feb. 05, 2018
Actual date of first enrollment		Mar. 27, 2018
Target sample size		30
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	no treatment control/standard of care control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Patients with vitiligo and concomitant seborrheic dermatitis or cutaneous fungal infection
	Exclusion Criteria	patients who did not agree to be registered in this project
	Age Minimum	1age old over
	Age Maximum	80age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Autoimmune vitiligo
Intervention(s)		apply topical anti-fungal agents to vitiligo lesion once or twice a day, its amount is equivalent to 0.1g to both palms lesion.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Re-pigmentation in vitiligo lesion
Secondary Outcome(s)		None

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Shizuoka cancer center
Address	1007 Shimonagakubo Chosen, Shizuoka 411-8777, Japan, Shizuoka
Telephone	+81-55-989-5222
E-Mail	rinsho_office@scchr.jp
Approval Status	Approval
Date of approval	Mar. 08, 2019

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	None

History of Changes

List of change history