UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056405 |
|---|---|
| Receipt number | R000064408 |
| Scientific Title | Research to elucidate the mechanism of sensitive skin with skin diseases |
| Date of disclosure of the study information | 2024/12/10 |
| Last modified on | 2025/10/21 17:03:57 |
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Basic information
Public title
Research to elucidate the mechanism of sensitive skin with skin diseases
Acronym
Research to elucidate the mechanism of sensitive skin with skin diseases
Scientific Title
Research to elucidate the mechanism of sensitive skin with skin diseases
Scientific Title:Acronym
Research to elucidate the mechanism of sensitive skin with skin diseases
Region
| Japan |
Condition
Condition
Atopic dermatitis, rosacea (erythematotelangiectatic rosacea), acne
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the mechanism of sensitive skin associated with skin diseases, we will conduct skin sampling and gene expression analysis using microbiopsy on research subjects with sensitive skin associated with skin diseases such as AD, ETR, and acne. In addition, we will measure skin properties and conduct a questionnaire survey on triggering factors in order to elucidate the involvement of gene expression changes in sensitive skin symptoms and triggering factors.
Basic objectives2
Others
Basic objectives -Others
Elucidation of the mechanism of sensitive skin associated with skin diseases
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Gene expression in skin samples
Key secondary outcomes
Age, gender, information on skin diseases, allergic predisposition (obtained by blood test), facial image, skin property measurements (obtained by spectrophotometer, MPA), stratum corneum (obtained by tape stripping), presence of sensory irritation (obtained by lactic acid sting test), menstrual cycle, history of allergy/related diseases, lifestyle habits information (obtained by questionnaire).
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
| 30 | years-old | <= |
Age-upper limit
| 49 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Persons who have received an explanation of this study, understand it, and agree to participate in the study of their own free will (persons who have indicated informed consent).
2. Those who have subjective symptoms of sensitive skin and have a history of various skin diseases (AD, ETR, acne), or have self-recognition of such diseases. (iii) Persons who have completed the consent form and other documents.
3. Those who are able to fill out the consent form and other documents.
4. who are able to come to the designated facility on the day of the examination.
Key exclusion criteria
1. those with trauma scars or surgical scars on the cheek area (including under the eyes)
2. who have undergone cosmetic medical procedures (laser, photofacial, injection therapy, HIFU, etc.) or cosmetic surgical procedures (incision, thread lift, etc.) that affect the shape of the face
3. who have excessive suntanning on the face
4. who regularly visits tanning salons
5. who have been exposed to significant sun exposure before the day of this examination (e.g., sports activities during the daytime over a series of days)
6. who is expected to suffer from severe hay fever* by the day of the main examination (*level that requires a hospital visit)
7. those who drink alcohol excessively on a regular basis
8. who use corticosteroids (steroids) or immunomodulators (e.g., tacrolimus) on the face before the study date 8. is expected to use corticosteroids (steroids) or immunomodulators (e.g., tacrolimus) on the face before the study date
9. who are receiving hormone replacement therapy
10. taking oral contraceptives
11. who are allergic to rubbing alcohol or rubber
12. pregnant or lactating
13. who is currently participating in another clinical research study 14. who is currently participating in another clinical research study
14. who have symptoms of the common cold or a fever of 37.5 degrees Celsius or higher
15. who have a history of serious hepatic disorder, renal disorder, or myocardial infarction
16. those with severe anemia
Persons who have experienced sickness during blood collection. 18.
18. who have keloids (scars that are red, swollen, and difficult to heal)
19. who suffer from diabetes mellitus 20. who use antithrombotic drugs
20. who are using antithrombotic drugs
21. any other person deemed inappropriate by the principal investigator involved in the study.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Kenshi |
| Middle name | |
| Last name | Yamasaki |
Organization
ALOOP CLINIC & LAB
Division name
ALOOP CLINIC & LAB
Zip code
104-0061
Address
POLA Ginza Bldg. 4F, 1-7-7 Ginza, Chuo-ku, Tokyo
TEL
0120-506-182
k-yamasaki@aloop.clinic
Public contact
Name of contact person
| 1st name | Taku |
| Middle name | |
| Last name | Nishijo |
Organization
POLA Chemical Industries, Inc.
Division name
FRONTIER RESEARCH CENTER
Zip code
244-0812
Address
560 Kashio-cho, Totsuka-ku, Yokohama 244-0812 JAPAN
TEL
045-826-7232
Homepage URL
t-nishijo@pola.co.jp
Sponsor or person
Institute
POLA Chemical Industries, Inc.
Institute
Department
Personal name
Funding Source
Organization
POLA Chemical Industries, Inc.
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
Yamauchi Clinic IRB
Address
1-15-19, Jiyugaoka, Meguro-Ku, Tokyo, Japan
Tel
03-5575-5862
c-irb_ug@neues.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
| 2024 | Year | 12 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 11 | Month | 11 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 22 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 10 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Association of gene expression and various measurements with associated skin diseases in sensitive skin
Management information
Registered date
| 2024 | Year | 12 | Month | 09 | Day |
Last modified on
| 2025 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064408
