UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022700 |
|---|---|
| Receipt number | R000026019 |
| Scientific Title | The relationship of skin aging and KLK7 |
| Date of disclosure of the study information | 2016/06/11 |
| Last modified on | 2021/09/04 17:22:14 |
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Basic information
Public title
The relationship of skin aging and KLK7
Acronym
Skin aging and KLK7
Scientific Title
The relationship of skin aging and KLK7
Scientific Title:Acronym
Skin aging and KLK7
Region
| Japan |
Condition
Condition
normal subject
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the relationship of skin aging and KLK7.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Evaluation of the disruption of KLK7 in skin using immunohistochemistry.
2.Evaluation of expressed level of KLK7 in stratum corneum.
3.Evaluation of expressed level of KLK7 in blood.
Key secondary outcomes
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
Skin biopsy,blood collection,stratum corneum collection
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
Female
Key inclusion criteria
1.Japanese females over 20 years old at the informed consent.
2.Patients who understand in detail and have written consent for the study protocol.
Key exclusion criteria
1.Patients suffering from atopic dermatitis, psoriasis or netherton syndrome.
2.Patients having a severe sunburn within 2 weeks before the test.
3.Patients taking hormonal replacement therapy.
4.Patients taking chemical peeling and laser therapy, and using drugs such as hydroquinone, vitamin C, retinoic acid which were prescribed by a doctor within 3 month before the test.
5.Women who are pregnant, may be pregnant or breastfeeding.
6.Patients who are judged inappropriate to participate by investigators.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Akemi |
| Middle name | |
| Last name | Ishida-Yamamoto |
Organization
Asahikawa Medical University
Division name
Dermatology
Zip code
0788510
Address
Midorigaoka-Higashi 2-1-1-1, Asahikawa, Hokkaido, Japan
TEL
0166-68-2523
akemi@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | Satomi |
| Middle name | |
| Last name | Igawa |
Organization
Asahikawa Medical University
Division name
Dermatology
Zip code
0788510
Address
Midorigaoka-Higashi 2-1-1-1, Asahikawa, Hokkaido, Japan
TEL
0166-68-2523
Homepage URL
igasato@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa Medical University
Institute
Department
Personal name
Funding Source
Organization
Fancl corporation
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
Asahikawa Medical University
Address
Midorigaoka-Higashi, 2-1-1-1, Asahikawa, Hokkaido
Tel
0166-68-2297
rs-kk.g@asahikawa-med.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
| 2016 | Year | 06 | Month | 11 | Day |
Related information
URL releasing protocol
None
Publication of results
Unpublished
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
10
Results
KLK7 was found to be involved in the synthesis of laminin332, a basement membrane component, and elastin, a dermal component.
This suggests that KLK7 may be involved in the maintenance of skin elasticity.
Results date posted
| 2021 | Year | 09 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Five young adults (in their 20s and 30s) and five elderly adults (in their 50s or older) agreed to use the remaining normal tissue after surgical removal of skin tissue
Participant flow
Participants who were briefed on the test and gave consent before surgery were included in the study.
Adverse events
None
Outcome measures
Age-related changes in the localization and expression of KLK7, p21, elastin and other proteins in tissues
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 05 | Month | 23 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 23 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 13 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 11 | Day |
Last modified on
| 2021 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026019
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| Registered date | File name |
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