UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060329 |
|---|---|
| Receipt number | R000069010 |
| Scientific Title | Clinical Verification of the Skin Tear Preventive Effects of GGT Inhibitor Based Cosmetics in Older Adults |
| Date of disclosure of the study information | 2026/01/19 |
| Last modified on | 2026/01/12 16:08:10 |
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Basic information
Public title
A Study on the Efficacy of Cosmetics Containing GGT Inhibitors for Preventing Skin Tears in the Elderly
Acronym
A Study on the Efficacy of Cosmetics for Preventing Skin Tears in the Elderly
Scientific Title
Clinical Verification of the Skin Tear Preventive Effects of GGT Inhibitor Based Cosmetics in Older Adults
Scientific Title:Acronym
Clinical Verification of the Skin Tear Preventive Effects of Cosmetics in Older Adults
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate whether application of a cosmetic product containing a GGT inhibitor improves skin barrier function and tissue durability in older adults and contributes to the prevention of skin tears
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
New occurrence of skin tears 8 weeks after application initiation
Key secondary outcomes
Dermal thickness and collagen density
Stratum corneum hydration
Skin viscoelastic properties
Skin biomarkers
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
The GGT inhibitor-containing cosmetic (intervention group) will be applied to either dorsum and forearm of he subject for 8 weeks.
Interventions/Control_2
The GGT inhibitor-not containing cosmetic (control group) will be applied to either dorsum and forearm of he subject for 8 weeks.
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
Participants will be adults aged 65 years or older who are hospitalized or residing in long-term care facilities and who have a history of skin tears or meet at least one criterion on the forearm skin tear risk assessment tool, including senile purpura, dry skin, pseudocarps, or joint contractures.
Key exclusion criteria
Exclusion criteria include existing skin tears on the forearm or dorsal hand, cast immobilization, difficulty in observation due to contractures, skin diseases affecting evaluation, and systemic conditions that may interfere with the study.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Chizuko |
| Middle name | |
| Last name | Konya |
Organization
Ishikawa Prefectural Nursing
University
Division name
Department of Adult and Geriatric Nursing
Zip code
929-1210
Address
1-1 Gakuen-dai, Kahoku City, Ishikawa, JAPAN
TEL
076-281-8333
ckonya@ishikawa-nu.ac.jp
Public contact
Name of contact person
| 1st name | Hidemi |
| Middle name | |
| Last name | Ishii |
Organization
Graduate School of Nursing Science, Ishikawa Prefectural University of Nursing
Division name
Doctoral Programme in Nursing Science
Zip code
929-1210
Address
1-1 Gakuen-dai, Kahoku City, Ishikawa JAPAN
TEL
076-281-8333
Homepage URL
hideminemoto627@gmail.com
Sponsor or person
Institute
Ishikawa Prefectural Nursing
University
Institute
Department
Personal name
Funding Source
Organization
Ishikawa Prefectural Nursing
University
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ishikawa Prefectural University of Nursing Ethics Committee
Address
1-1 Gakuen-dai, Kahoku City, Ishikawa JAPAN
Tel
076-281-8300
rinri@ishikawa-nu.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
医療法人三星会 介護老人保健施設 レストア横浜 （神奈川県 ）
医療法人社団浅ノ川 千木病院（石川県）
医療法人社団 湘南会亀有中央病院 （東京都）
医療法人社団輝生会 初台リハビリテーション病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 19 | 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 | 12 | Month | 15 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 15 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 13 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2028 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2028 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2030 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2026 | Year | 01 | Month | 12 | Day |
Last modified on
| 2026 | Year | 01 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069010
