UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049756 |
|---|---|
| Receipt number | R000056671 |
| Scientific Title | Research on skin conditions, body odor, and bacterial flora in elderly people with different degrees of independence in daily life |
| Date of disclosure of the study information | 2022/12/12 |
| Last modified on | 2023/06/13 11:19:33 |
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Basic information
Public title
Research on skin conditions, body odor, and bacterial flora in elderly people with different degrees of independence in daily life
Acronym
Research on skin conditions, body odor, and bacterial flora in elderly people with different degrees of independence in daily life
Scientific Title
Research on skin conditions, body odor, and bacterial flora in elderly people with different degrees of independence in daily life
Scientific Title:Acronym
Research on skin conditions, body odor, and bacterial flora in elderly people with different degrees of independence in daily life
Region
| Japan |
Condition
Condition
older adults
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of skin condition, resident bacteria and body odor in the elderly to clarify the relationship between physical changes and health.
Basic objectives2
Others
Basic objectives -Others
Observational study.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Dorsal body odor evaluation
Key secondary outcomes
Skin moisture content of the back and the inner part of the forearm of one arm, blood flow, skin imaging, skin color, Assessing Differences.
Bacterial flora analysis of vulva and oral cavity.
Questionnaire on the presence or absence of subjective and objective symptoms for skin symptoms and body odor conditions linked to primary and secondary endpoints.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Restrictions on activities in terms of bathing and eating due to body odor evaluation.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Women who live or commute to a long-term care facility for the elderly and fall under the rank of J, A, or B in the degree of independence in daily life of elderly people with disabilities stipulated by the Ministry of Health, Labour and Welfare.
Key exclusion criteria
(1) Those who are undergoing antimicrobial treatment
(2) Those who have participated in other studies within one week before the start of the study, or those who plan to participate in other studies within the test period after agreeing to this study.
(3) Those who are judged to be ineligible by the person in charge of the research, or who are judged by the principal investigator to be inappropriate as research subjects.
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Sachiko |
| Middle name | |
| Last name | Noyori |
Organization
ROHTO PHARMACEUTICAL CO.,LTD.
Division name
Pharmaceutical&Device Development Division
Zip code
5448666
Address
1-8-1,Tatsumi-nishi,Ikuno-ku,Osaka
TEL
0667588213
pd3_gaiyou@rohto.co.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Kaneko |
Organization
ROHTO PHARMACEUTICAL CO.,LTD.
Division name
Pharmaceutical&Device Development Division
Zip code
5448666
Address
1-8-1,Tatsumi-nishi,Ikuno-ku,Osaka
TEL
0667588213
Homepage URL
pd3_gaiyou@rohto.co.jp
Sponsor or person
Institute
ROHTO PHARMACEUTICAL CO.,LTD.
Institute
Department
Personal name
Funding Source
Organization
ROHTO PHARMACEUTICAL CO.,LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
ROHTO PHARMACEUTICAL CO.,LTD.
Address
1-8-1,Tatsumi-nishi,Ikuno-ku,Osaka
Tel
06-6758-6925
rohtoirb@rohto.co.jp
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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 12 | Month | 12 | 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
36
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
| 2022 | Year | 11 | Month | 21 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 12 | Day |
Last follow-up date
| 2023 | Year | 02 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 12 | Month | 12 | Day |
Last modified on
| 2023 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056671
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
