UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059539 |
|---|---|
| Receipt number | R000067917 |
| Scientific Title | Improvement Effects of Intake of Resveratrol-containing Extracts from Pterocarpus marsupiumand and Red Wine Combined with Palmitoyl Vitamin C on Human Skin Blotch |
| Date of disclosure of the study information | 2025/12/01 |
| Last modified on | 2025/10/25 17:49:07 |
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Basic information
Public title
Improvement Effects of Intake of Resveratrol-containing Extracts from the Indian traditional medicine Pterocarpus marsupiumand and Red Wine Combined with Palmitoyl Vitamin C on Human Skin Blotch
Acronym
Effects of Resveratrol Combined with Vitamin C Derivative on Human Skin Blotch
Scientific Title
Improvement Effects of Intake of Resveratrol-containing Extracts from Pterocarpus marsupiumand and Red Wine Combined with Palmitoyl Vitamin C on Human Skin Blotch
Scientific Title:Acronym
Improvement Effects of Resveratrol-containing Extracts from Pterocarpus marsupiumand and Red Wine Combined with Palmitoyl Vitamin C on Human Skin Blotch
Region
| Japan |
Condition
Condition
Skin Blotch
Classification by specialty
| Aesthetic surgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It is clinically examined whether Improvement Effects of Intake of Resveratrol-containing Extracts from Pterocarpus marsupiumand and Red Wine Combined with Palmitoyl Vitamin C on Human Skin Blotch.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
It is examined whether skin blotch can be improved.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Placebo. Intervention by administration for 30 days at a dose of 500-550 mg per one subject, once for a day.
Interventions/Control_2
Vitamin C Palmitate. Intervention by administration for 30 days at a dose of 500-550 mg per one subject, once for a day.
Interventions/Control_3
Resveratrol plus Vitamin C Palmitate. Intervention by administration for 30 days at a dose of 500-550 mg per one subject, once for a day.
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
| 27 | years-old | <= |
Age-upper limit
| 63 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
No diseases, Japanese persons, normal blotch degrees in face and sun-exposed skin.
Key exclusion criteria
Persons with some serious disease. Underage and highly elder.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Nobuhiko |
| Middle name | |
| Last name | Miwa |
Organization
Specified Nonprofit Organization Japanese Center for Anti-Aging Medical Sciences
Division name
Division of Research Development
Zip code
727-0023
Address
Mineta Cho 1177, Shobara City, Hiroshima
TEL
072-320-2900
jpn.cntr.antiaging.medsci2002@leto.eonet.ne.jp
Public contact
Name of contact person
| 1st name | Nobuhiko |
| Middle name | |
| Last name | Miwa |
Organization
Specified Nonprofit Organization Japanese Center for Anti-Aging Medical Sciences
Division name
Division of Research Development
Zip code
593-8322
Address
Tsukuno3-29-25, Nishi-ku, Sakai City, Osaka
TEL
070-5679-7416
Homepage URL
vitamin2002rejuvenation@yahoo.co.jp
Sponsor or person
Institute
Specified Nonprofit Organization Japanese Center for Anti-Aging Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
Specified Nonprofit Organization Japanese Center for Anti-Aging Medical Sciences
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Specified Nonprofit Organization Japanese Center for Anti-Aging Medical Sciences
Address
Tsukuno 3-29-25, Nishi-ku, Sakai City, Osaka
Tel
070-5679-7416
vitamin2002rejuvenation@yahoo.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
| 2025 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
9
Results
Oral administration with 6-O-palmitoyl ascorbate [VcPlm] for C-group, VcPlm plus resveratrol for R-group, or placebo for P-group, for 30 days, respectively. Blotch degrees were not improved for P-group, partially significantly improved for C-group, and appreciably improved for R-group. The blotch degrees were indicated to reflect the densities and areas in photography to each blotch.
Results date posted
| 2025 | Year | 10 | Month | 25 | Day |
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 | 02 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 10 | Month | 25 | Day |
Last modified on
| 2025 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000067917
