UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041136 |
|---|---|
| Receipt number | R000046982 |
| Scientific Title | Investigation of methods for collecting substances causing odor from axillae for patients with osmidrosis axillae and volunteers |
| Date of disclosure of the study information | 2020/07/20 |
| Last modified on | 2022/01/17 12:25:01 |
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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
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
m-ito@trco.co.jp
Sponsor or person
Institute
Shinanozaka Clinic
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046982
