UMIN-CTR Clinical Trial

Basic information
Public title	Investigation of methods for collecting substances causing odor from axillae for patients with osmidrosis axillae and volunteers
Acronym	Investigation of methods for collecting substances causing odor from axillae
Scientific Title	Investigation of methods for collecting substances causing odor from axillae for patients with osmidrosis axillae and volunteers
Scientific Title:Acronym	Investigation of methods for collecting substances causing odor from axillae
Region	Japan

Condition
Condition	osmidrosis axillae
Classification by specialty	Dermatology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the usefulness of five methods for collecting substances causing odor from axillae both in terms of whether it can collect them and in terms of collection amount.
Basic objectives2	Others
Basic objectives -Others	To investigate the relationship between amount of substances causing odor from axillae and axillary odor score.
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	The collection amount of three substances causing odor from axillae. (3-Hydroxy-3-methylhexanoic acid(HMHA),3-Methyl-2-hexenoic acid (3M2H),3-Methyl-3-sulfanylhexan-1-ol(3M3SH)
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	1) Subject who has Japanese nationality and is from 20 to less than 65 years old at the time of informed consent 2) For patients, subjects who has axillary odor score 1 or more For volunteers, subjects who has axillary odor score 0
Key exclusion criteria	1)Subjects who has complications in axilla 2)Subjects who has any severe disease or medical history determined by investigator to be unsuitable for the study,e.g.liver, kidney,cardiac,digestive organ,circulatory organ,blood,respiratory,et cetera. 3)For volunteers, subjects who has complications or medical history of osmidrosis axillae and who has been told that axillary odor by somebody 4)Subjects who has sensitivities for alcohol 5)Subjects who have not completely disappered following symptoms within 14 days before visit;symptoms suspected or associated with COVID-19 infection such as fever, respiratory symptoms (cough, sore throat, nasal discharge, etc), malaise, taste/olfaction disorder ,etc. 6)Subjects who contacted directly with Covid-19 patients within 14 days before visit. 7)Subjects who are judged as ineligible for this study by the investigator
Target sample size	12

Research contact person
Name of lead principal investigator	1st name Takeshi Middle name Last name Ouchi
Organization	Shinanozaka Clinic
Division name	Medical office
Zip code	160-0017
Address	Yotsuya Medical Bidg.20,Samoncho,Shinjuku-ku,Tokyo
TEL	03-5366-3006
Email	takeshi-ouchi.z5@keio.jp

Public contact
Name of contact person	1st name Michiyo Middle name Last name Ito
Organization	Tokyo Research Center of Clinical Pharmacology
Division name	Clinical Research Promotion
Zip code	160-0017
Address	Yotsuya Medical Bidg.20,Samoncho,Shinjuku-ku,Tokyo
TEL	03-5366-3006
Homepage URL
Email	m-ito@trco.co.jp

Sponsor
Institute	Shinanozaka Clinic
Institute
Department

Funding Source
Organization	Maruho co.,Itd
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Shinanozaka Clinic
Address	Yotsuya Medical Bidg.20,Samoncho,Shinjuku-ku,Tokyo
Tel	03-5366-3006
Email	h-fuchii@shinanokai.com

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	医療法人社団信濃会信濃坂クリニック（東京都）

Other administrative information
Date of disclosure of the study information	2020 Year 07 Month 20 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2020 Year 06 Month 30 Day
Date of IRB	2020 Year 07 Month 15 Day
Anticipated trial start date	2020 Year 07 Month 26 Day
Last follow-up date	2021 Year 06 Month 30 Day
Date of closure to data entry	2022 Year 01 Month 05 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information	-

Management information
Registered date	2020 Year 07 Month 17 Day
Last modified on	2022 Year 01 Month 17 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000046982