UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053463 |
|---|---|
| Receipt number | R000060958 |
| Scientific Title | Verification of the effect of bathing solutions and emulsions on skin flares in the elderly. |
| Date of disclosure of the study information | 2024/01/29 |
| Last modified on | 2024/02/28 08:57:23 |
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Basic information
Public title
Verification of the effect of bathing solutions and emulsions on skin flares in the elderly.
Acronym
Verification of the effect of bathing solutions and emulsions on skin flares in the elderly.
Scientific Title
Verification of the effect of bathing solutions and emulsions on skin flares in the elderly.
Scientific Title:Acronym
Verification of the effect of bathing solutions and emulsions on skin flares in the elderly.
Region
| Japan |
Condition
Condition
old people
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to examine the effects of the combined use of a medicated bath solution and a medicated full-body moisturising emulsion on skin flares in the elderly and to contribute to the prevention of skin flares.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
moisyuer content elasticity textuer
2 weeks before the start of the study, on the day the study starts, 2 weeks after the intervention, 4 weeks after the intervention and 2 weeks after the study is discontinued.
Key secondary outcomes
scaling, redness, roughness, cracks
sleep and wakefulness rhythms
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Period of using nothing (2 weeks), period of using medicated bath solution and medicated full-body moisturising emulsion (4 weeks), period of using nothing (2 weeks)
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Elderly people aged 65 and over who are in care homes and are able to bathe independently or with the assistance of care staff.
Key exclusion criteria
People with wounds on the skin that are undergoing treatment.
People who have difficulty bathing.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Iiyama |
Organization
Kumamoto Health Science University
Division name
Career Education And Training Center
Zip code
8615598
Address
325 Izumi-machi, Kita-ku, Kumamoto City 861-5598, Japan
TEL
096-275-2111
iiyama-yu@kumamoto-hsu.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Iiyama |
Organization
Kumamoto Health Science University
Division name
Career Education And Training Center
Zip code
8615598
Address
325 Izumi-machi, Kita-ku, Kumamoto City 861-5598, Japan
TEL
096-275-2111
Homepage URL
iiyama-yu@kumamoto-hsu.ac.jp
Sponsor or person
Institute
Kumamoto Health Science University
Institute
Department
Personal name
Funding Source
Organization
BATHCLIN
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
Kumamoto Health Science University
Address
325 Izumi-machi, Kita-ku, Kumamoto City 861-5598, Japan
Tel
096-275-2112
kikaku@kumamoto-hsu.ac.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
| 2024 | Year | 01 | Month | 29 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 01 | Month | 29 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 30 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 01 | Month | 28 | Day |
Last modified on
| 2024 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060958
| 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 |
