臨床研究等提出・公開システム

Date of registration	Mar. 20, 2024
Last modified on	April. 03, 2024
Trial ID	jRCT1041230174

Scientific Title	Axillary hyperhidrosis in Children (AICHI) study
Public Title	Axillary hyperhidrosis in Children (AICHI) study

Contact for Scientific Queries	Name	Oshima Yuichiro
	Affiliation	Aichi Medical University School of Medicine
	Address	1-1, Yazakokarimata, Nagakute, Aichi
	Telephone	+81-561-62-3311
	E-mail	y45123@aichi-med-u.ac.jp
Contact for Public Queries	Name	Oshima Yuichiro
	Affiliation	Aichi Medical University School of Medicine
	Address	1-1, Yazakokarimata, Nagakute, Aichi
	Telephone	+81-561-62-3311
	E-mail	y45123@aichi-med-u.ac.jp

Recruitment status	Not Recruiting

Anticipated date of first enrollment		Mar. 20, 2024
Target sample size		100
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	Pediatric patients with severe axillary hyperhidrosis who scheduled to prescribe sofpironium, who understand the purpose of the study and give their consent.
	Exclusion Criteria	The relevant therapy included herbal medicines for reducing symptoms of hyperhidrosis. Systemic and topical anticholinergics, oral cholinergic agonists, oral cholinergic agonists, serotonin agonsts, dopamine partial agonists, tricyclic antidepressants, aluminum chloride, medications for hyperhidrosis approved outside Japan, and tap water iontophoresis (within 30 days) Botulinum toxin (within 9 months). In addition, patients with angle-closure glaucoma, patients with dysuria due to benign prostatic hyperplasia, or patients with a history of hypersensitivity to any of the ingredients of sofpironium (active ingredient: sofpironium bromide; additives: hydroxypropyl cellulose, hexylene glycol, isopropyl myristate, anhydrous citric acid, anhydrous ethanol)
	Age Minimum	6age old over
	Age Maximum	14age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Primary axillary hyperhidrosis
Health Condition(s) Keyword		Primary axillary hyperhidrosis
Primary Outcome(s)		The primary endpoint for the effectiveness was change in the proportion of patients with an HDSS score of 1 or 2 during the 2,4-week study period.
Secondary Outcome(s)		Change in the mean HDSS score from baseline to Week 2,4. Change in the mean CDLQI score from baseline to Week 4. Change in the mean VAS for Sweating from baseline to Week 2,4

Primary Sponsor	Kaken Pharmaceutical Co., Ltd

Secondary Sponsor	Not applicable

Name of Certified Review Board	Ethics Committee , Aichi Medical University school of Medicine
Address	1-1, Yazakokarimata, Nagakute, Aichi, Aichi
Telephone	+81-561-62-3311
E-Mail	amu_ethics@aichi-med-u.ac.jp
Approval Status	Approval
Date of approval	Mar. 27, 2023

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	April. 03, 2024	(this page)	Changes
1	Mar. 20, 2024	Detail

List of change history