UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056990 |
|---|---|
| Receipt number | R000065126 |
| Scientific Title | Observation of changes in skin condition and evaluation of sensory and usability after use of body wash and body lotion in elderly dialysis patients |
| Date of disclosure of the study information | 2025/02/10 |
| Last modified on | 2025/02/10 11:22:07 |
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Basic information
Public title
Observation of changes in skin condition and evaluation of sensory and usability after use of body wash and body lotion in elderly dialysis patients
Acronym
Observation of changes in skin condition and evaluation of sensory and usability after use of body wash and body lotion in elderly dialysis patients
Scientific Title
Observation of changes in skin condition and evaluation of sensory and usability after use of body wash and body lotion in elderly dialysis patients
Scientific Title:Acronym
Observation of changes in skin condition and evaluation of sensory and usability after use of body wash and body lotion in elderly dialysis patients
Region
| Japan |
Condition
Condition
Chronic Kidney Disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
By observing changes in skin condition of maintenance hemodialysis patients before and after application of the test product, we will evaluate whether the risk of skin frailty can be improved.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Before and after 4 weeks of continuous use of the test product, skin frailty checklist scoring for forearm
Key secondary outcomes
1. Before and after 4 weeks of continuous use of the test product, photographing the appearance, measuring the stratum corneum moisture content, skin viscoelasticity, dermal thickness, and SRRC scoring for forearm
2. Before and after 4 weeks of continuous use of the test product, skin frailty checklist scoring, photographing the appearance, measuring the stratum corneum moisture content, skin viscoelasticity, dermal thickness, and SRRC scoring for front shin
3. Questionnaire regarding subjective or objective symptoms of skin conditions linked to the primary and secondary endpoints, and questionnaire regarding sensory and usability
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
| Other |
Interventions/Control_1
Apply body soap and lotion
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
<Geriatric research subjects>
1. Men and women aged 65 or older
2. Maintenance hemodialysis patients with dry skin and no skin diseases
3. Outpatients or hospitalized patients who fall under the rank of J, A, B,or C in the degree of independence in daily life of elderly people with disabilities stipulated by the Ministry of Health, Labour and Welfare.
4. Those who can replace their usual body wash and body lotion with the test product
<Nurse research subjects>
Nurses working in hospitals who daily apply cleansers and lotions to elderly subjects.
Key exclusion criteria
1. Those who have participated in other studies within one week prior to the start of the study, or those who plan to participate in other studies during the study period after consenting to this study.
2. Those who are judged ineligible by the study staff, or those who are judged inappropriate as study subjects by the joint study organization or the study principal physician.
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | Akiyori |
| Middle name | |
| Last name | Fujiwara |
Organization
ROHTO PHARMACEUTICAL CO.,LTD.
Division name
Skincare Products Development Division
Zip code
544-8666
Address
1-8-1,Tatsumi-nishi,Ikuno-ku,Osaka
TEL
06-6758-8214
skincare@rohto.co.jp
Public contact
Name of contact person
| 1st name | Yuka |
| Middle name | |
| Last name | Matsuura |
Organization
ROHTO PHARMACEUTICAL CO.,LTD.
Division name
Skincare Products Development Division
Zip code
544-8666
Address
1-8-1,Tatsumi-nishi,Ikuno-ku,Osaka
TEL
06-6758-8214
Homepage URL
skincare@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
Hasuda Isshinnkai Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
ROHTO PHARMACEUTICAL CO.,LTD. Clinical Research Ethics Committee
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
蓮田一心会病院（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 02 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 02 | Month | 03 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 03 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 10 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 02 | Month | 10 | Day |
Last modified on
| 2025 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065126
