UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055967 |
|---|---|
| Receipt number | R000063957 |
| Scientific Title | Study of the effects and influence of mitochondrial biogenesis inducing extract on skin parameters |
| Date of disclosure of the study information | 2024/10/31 |
| Last modified on | 2025/02/28 17:35:18 |
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Basic information
Public title
Study of the effects and influence of mitochondrial biogenesis inducing extract on skin parameters
Acronym
Study of the effects and influence of mitochondrial biogenesis inducing extract on skin parameters
Scientific Title
Study of the effects and influence of mitochondrial biogenesis inducing extract on skin parameters
Scientific Title:Acronym
Study of the effects and influence of mitochondrial biogenesis inducing extract on skin parameters
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Exploratory evaluation of effect on the skin of applying mitochondrial biogenesis inducing extract twice a day (morning and evening) to the face on adults (30 to 59 years old) for 12 weeks
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skin image analysis
(at before, 4 weeks after, 8 weeks after and 12 weeks after ingestion.)
Key secondary outcomes
Skin viscoelasticity (left and right of upper cheek and lower cheek)
(at before, 2weeks after, 8 weeks after and 12 weeks after ingestion.)
Skin wrinkles, skin color (corner of the eye, eye area, and mouth area), questionnaire (skin, feel of use, etc.) and visual evaluation of images (wrinkle grade)
(at before, 4weeks after, 8 weeks after and 12 weeks after ingestion.)
Visual evaluation of images (sagging score)
(at before, 8 weeks after and 12 weeks after ingestion.)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Apply mitochondrial biogenesis inducing extract to face twice a day (morning and evening) for 12 weeks
Interventions/Control_2
Apply placebo to face twice a day (morning and evening) for 12 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
| 30 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male
Key inclusion criteria
1.Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate
2.Adults who are 30 years old or more and under 60 years old
Key exclusion criteria
1.Persons who have chronic illness, receiving medication, have a serious disease history
2.Persons who are allergic to the test food
3.Persons who usually take a large amount of basic skincare products
4.Persons who regularly use basic skincare products, medicines, foods for specified health use, health foods, etc. that may affect anti-aging or skin function
5.Persons who have participated in other tests within the first month before the start of the test, or those who intend to participate in another exam after consenting to this exam
6.Persons who were judged as inappropriate for study participants by the principal investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Oshium |
Organization
Saishunkan Pharmaceutical co.,ltd
Division name
Research and development department
Zip code
861-2201
Address
1363-1 Jichu Mashiki-machi, Kamimashiki-gun, Kumamoto-ken, Japan
TEL
096-289-4444
h.oshiumi@saishunkan.co.jp
Public contact
Name of contact person
| 1st name | Chisato |
| Middle name | |
| Last name | Furusawa |
Organization
Saishunkan Pharmaceutical co.,ltd
Division name
Research and development department
Zip code
861-2201
Address
1363-1 Jichu Mashiki-machi, Kamimashiki-gun, Kumamoto-ken, Japan
TEL
080-9458-5381
Homepage URL
c.furusawa@saishunkan.co.jp
Sponsor or person
Institute
Saishunkan Pharmaceutical co.,ltd
Institute
Department
Personal name
Funding Source
Organization
Saishunkan Pharmaceutical co.,ltd
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
The Ethics Committee of Healthcare Systems Co., Ltd.
Address
1-14-18, Shirakane, Showa-ku, Nagoya, Aichi, JAPAN
Tel
03-6809-2722
soumu@hc-sys.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 | 10 | Month | 31 | 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
20
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
Completed
Date of protocol fixation
| 2024 | Year | 10 | Month | 21 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 21 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 28 | 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
Management information
Registered date
| 2024 | Year | 10 | Month | 28 | Day |
Last modified on
| 2025 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063957
