UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052271 |
|---|---|
| Receipt number | R000059639 |
| Scientific Title | A cross-sectional study to investigate the association between the Skin condition and Advanced Glycation Endproducts. |
| Date of disclosure of the study information | 2023/10/01 |
| Last modified on | 2025/07/22 10:16:50 |
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Basic information
Public title
A cross-sectional study to investigate the association between the Skin condition and Advanced Glycation Endproducts.
Acronym
Clinical trial to investigate the association between the Skin condition and Advanced Glycation Endproducts.
Scientific Title
A cross-sectional study to investigate the association between the Skin condition and Advanced Glycation Endproducts.
Scientific Title:Acronym
Clinical trial to investigate the association between the Skin condition and Advanced Glycation Endproducts.
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the association between the skin condition and Advanced Glycation Endproducts.
Basic objectives2
Others
Basic objectives -Others
To investigate the association between the transepidermal water loss and Advanced Glycation Endproducts or skin viscoelasticity and Advanced Glycation Endproducts.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between Stratum corneum water content and Advanced Glycation Endproducts.
Key secondary outcomes
1. Correlation between transepidermal water loss and AGEs.
2. Correlation between skin viscoelasticity and AGEs.
3. Adverse events.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Subjects who are judged as healthy by self-reported health questionnaire.
2. Subjects who agree to participate in this study with a written informed consent after receiving sufficient explanation relating to this study.
Key exclusion criteria
1. Subjects who answered in the self-reported health questionnaire that they currently have a skin disease that requires treatment.
2. Subjects who answered in the self-reported health questionnaire that they have had or are currently suffering from respiratory, gastrointestinal,hepatic/gallbladder/pancreatic, hematologic, renal, endocrine, cardiovascular and/or mental disease that requires hospital treatment.
3. Subjects who had a serious injury or surgical history within 12 weeks prior to this study.
4. Heavy smokers (more than 21 cigarettes per day), alcohol addicts (more than 80g per day alcohol), subjects who are alcohol or drug dependence, subjects who are suspected of alcohol or drug dependence.
5. Subjects who are undergoing special facial care (e.g. facial appliances, aesthetic treatments, peels, laser treatments, etc.) which would affect this study.
6. Subjects who are pregnant or lactating, or subjects who expect to be pregnant during this study.
7. Subjects who have cognitive disorder or who have possibility of the disorder.
8. Subjects who participated and took the study drug in other clinical trials within twelve weeks prior to this study.
9. Subjects who are judges as unsuitable for this study by the principal investigator or subinvestigators.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yasuji |
| Middle name | |
| Last name | Arimura |
Organization
University of Miyazaki
Division name
Department of Health-Care Research, University of Miyazaki Hospital, Organization for Promotion of Research and Industry-Academic Regional Collaboration, University of Miyazaki(Kiyotake Branch)
Zip code
889-1692
Address
Kihara5200,Kiyotake,Miyazaki889-1692,Japan
TEL
0985-85-9577
yasuji_arimura@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Miho |
| Middle name | |
| Last name | Kuroki |
Organization
University of Miyazaki
Division name
Department of Health-Care Research, University of Miyazaki(Kiyotake Branch)
Zip code
889-1692
Address
Kihara5200,Kiyotake,Miyazaki889-1692,Japan
TEL
0985-85-9577
Homepage URL
m-kuroki@med.miyazaki-u.ac.jp
Sponsor or person
Institute
University of Miyazaki
Institute
Department
Personal name
Funding Source
Organization
University of Miyazaki
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of University of Miyazaki
Address
Kihara 5200, Kiyotake, Miyazaki 889-1692, Japan
Tel
0985-85-9010
igakubu_kenkyu@med.miyazaki-u.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
| 2023 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000059639
Publication of results
Unpublished
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000059639
Number of participants that the trial has enrolled
42
Results
No significant associations were observed between fingertip skin AGEs levels measured by the AGEs sensor and stratum corneum hydration, transepidermal water loss (TEWL), or skin viscoelasticity.
Results date posted
| 2025 | Year | 07 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 40 healthy adults were enrolled as eligible participants. The mean age was 39.3 +- 11.1 years. The study population included 11 men (27.5%) and 29 women (72.5%), indicating a predominance of female participants. Based on BMI, three participants (7.5%) were classified as obese. Nine participants (22.5%) showed abnormal lipid profiles in blood tests, while none exhibited glycemic patterns indicative of diabetes.
Participant flow
Fifty-eight individuals applied to participate in the study. Sixteen were excluded due to eligibility criteria or scheduling conflicts, leaving 42 potential participants. After obtaining informed consent from all 42 individuals, two were subsequently excluded upon identification of exclusion criteria: one was undergoing treatment for dyslipidemia, and the other for a skin condition. As a result, 40 participants were included in the final analysis.
Adverse events
No study-related adverse events occurred during the study period.
Outcome measures
No significant correlations were found between the primary outcome-stratum corneum hydration-and fingertip skin AGEs levels. Similarly, no significant associations were observed for the secondary outcomes, including TEWL and fingertip AGEs levels. However, a weak negative correlation was found only between cheek R6 (a parameter of skin viscoelasticity) and fingertip AGEs levels. Multivariate analyses adjusting for age, sex, blood test results, and nutrient intake revealed no significant associations between any of the skin measurements and fingertip AGEs levels.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 15 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 15 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 21 | Day |
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
-Cross-sectional study.
-Items to be measured: Basic information of the subjects (gender, occupational history, etc), Measurement of skin (Stratum corneum water content, transepidermal water loss, skin viscoelasticity), Vital signs (Blood Pressure, Heart Rate), Blood test((Hematological tests: peripheral blood, hemogram)( biochemical examination of blood: Total protein, Albumin, AST, ALT, Glu, Insulin, HbA1c(NGSP), LDL-cho, HDL-cho, TG, etc)), questionnaire (dietary intake(BDHQ), Living situation, physical condition, Fitzpatrick Skin Type, body measurements (height, weight, BMI, abdominal circumference), body composition (muscle mass, extremity skeletal muscle mass, skeletal muscle mass index, fat mass, body fat percentage), visceral fat area, AGEs.
Management information
Registered date
| 2023 | Year | 09 | Month | 21 | Day |
Last modified on
| 2025 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059639
