臨床研究等提出・公開システム

Japanese

Date of registration	Feb. 22, 2023
Last modified on	April. 10, 2025
Trial ID	jRCT2031220654

Scientific Title	Clinical Evaluation of Metal Panel Allergens: Safety and Efficacy Study
Public Title	Metal Panel Patch Test Study

Contact for Scientific Queries	Name	Oobuchi Tomoko
	Affiliation	SmartPractice Japan,Inc.
	Address	2-2-13, Asahi Yamto BLD. 2F, Yamatohigashi, Yamato, Kanagawa
	Telephone	+81-46-200-5620
	E-mail	toobuchi@smarthealth.com
Contact for Public Queries	Name	Oobuchi Tomoko
	Affiliation	SmartPrtactice Japan, Inc.
	Address	2-2-13, Asahi Yamato Building 2F Yamato Higashi, Yamato City,
	Telephone	+81-46-200-5617
	E-mail	toobuchi@smarthealth.com

Recruitment status	Recruiting

Anticipated date of first enrollment		Feb. 22, 2023
Actual date of first enrollment		Feb. 07, 2023
Target sample size		300
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	active control
	assignment	parallel assignment
	purpose	diagnostic purpose
Key inclusion & exclusion criteria	Inclusion Criteria	The study population will consist of two groups of subjects. Group 1 will include the intended population, individuals with suspected allergic contact dermatitis to one or more of the investigational metal allergens. Subjects may have active dermatitis attributable to metal allergy at the time of enrollment or a recent history (within the past 5 years) of dermatitis that is suspected to be due to metal allergy that resolved prior to enrollment due to treatment or elimination of exposure to the suspected metal trigger. Group 2 will include patients without history or symptoms of metal-induced allergic contact dermatitis and without chronic exposure
	Exclusion Criteria	Participation in SmartPractice dose response study Breastfeeding or pregnant Topical treatment with corticosteroids or immunosuppressive agents on or near the test area Systemic treatment with corticosteroids or immunosuppressive agents Treatment with UV light Dermatitis on or near the test area on the back Known or suspected infection of the skin, joints or other site(s) associated with metal exposure Fibromyalgia, chronic fatigue, depression, cognitive impairment, flu-like symptoms, diarrhea and/or headache without at least one of the symptoms related to metal exposure Psoriasis, dermatitis herpetiformis, mycosis fungoides or cutaneous T-cell lymphoma Inability to comply with patch test study requirements Participation in an investigational clinical trial 3 weeks prior to inclusion in this study. An opinion of the Investigator that deems the potential subject is unsuitable
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Skin rash, Eczema
Intervention(s)		Diagnostic skin test for contact allergy Apply patchtest panel 1 time
Health Condition(s) Keyword		Skin rash, Eczema
Intervention(s) Keyword		Eczema
Health Condition(s) Code		D000066491
Intervention(s) Code		D003877
Primary Outcome(s)		Elicitation of allergic reaction.
Secondary Outcome(s)		Allergen safety

Primary Sponsor	SmartPractice

Name of Certified Review Board	Institutional Review Board Medical Corporation Shinwakai Adachi Mutual Aid Hospital
Address	1-358 Yanagihara Adachi-ku, Tokyo, Tokyo
Approval Status	Approval
Date of approval	Dec. 05, 2022

Name of Certified Review Board	Institutional Review Board Non-profic Organization Clinical Research
Address	2-2-1 Kyobashi Chuo-ku Tokyo, Tokyo
Approval Status	Approval
Date of approval	Dec. 05, 2022

Name of Certified Review Board	Showa Medical University Fujigaoka Hospital Institutional Review Board
Address	1-30, Fujigaoka, Aoba-ku Yokohama, Kanagawa Japan 2278501, Tokyo
Approval Status	Approval
Date of approval	Dec. 05, 2022

Name of Certified Review Board	Clinical Trial Center for Developmental Therapeutics Tokushima University Hospital
Address	2-50-1 Kuramoto-cho 770-8503 Tokushima, Japan, Tokyo
Approval Status	Approval
Date of approval	Dec. 05, 2022

Name of Certified Review Board	The Central Institutional Review Board for the Fujita Health University Hospitals
Address	1-98, Dengakugakubo, Kutsukake-cho, Toyoake-city, Aichi, Japan, Tokyo
Approval Status	Approval
Date of approval	Dec. 05, 2022

Name of Certified Review Board	Institute of Science Tokyo Hospital Review Board
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan, Tokyo
Telephone	+81-3-5803-4575
E-Mail	tiken.crc@tmd.ac.jp
Approval Status	Approval
Date of approval	Dec. 05, 2022

Plan to share IPD	Yes
Plan description	Data sharing is the practice of making data available to other investigators. At the conclusion of the study, the data will be made available to other investigators on clinicaltrials.gov. All investigators involved in the study will receive a copy of the final report.

Secondary ID(s)	NCT04500834
Issuing Authority	Clinicaltrials.gov

Countries of Recruitment（Except Japan）	USA/Germany/Italy/Netherland

History of Changes

No	Publication date
4	April. 10, 2025	(this page)	Changes
3	Oct. 02, 2024	Detail	Changes
2	Mar. 03, 2023	Detail	Changes
1	Feb. 22, 2023	Detail

List of change history