UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039612 |
|---|---|
| Receipt number | R000045158 |
| Scientific Title | Effects of Apple polyphenol administration on the skin parameters induced by UV-irradiation |
| Date of disclosure of the study information | 2020/12/31 |
| Last modified on | 2020/02/26 19:19:56 |
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Basic information
Public title
Effects of Applephenon administration on the skin whitening and moisture condition
Acronym
Effects of Applephenon administration on the skin whitening and moisture condition
Scientific Title
Effects of Apple polyphenol administration on the skin parameters induced by UV-irradiation
Scientific Title:Acronym
Effects of Apple polyphenol administration on the skin parameters induced by UV-irradiation
Region
| Japan |
Condition
Condition
Skin pigmentation induced by UV-irradiation
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigated whether orally administrated apple polyphenols (Applephenon) could inhibit the pigmentation in the skin induced by UV irradiation in human clinical trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
erythema value, L value, melanin value, transepidermal water loss, moisture, questionnaire
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
12 weeks chronic administration of placebo tablets
Interventions/Control_2
12 weeks AP low-dose group (apple polyphenol 300 mg) per day
Interventions/Control_3
12 weeks AP high-dose group (apple polyphenol 600 mg) per 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
| 20 | years-old | <= |
Age-upper limit
| 39 | years-old | >= |
Gender
Female
Key inclusion criteria
20 and 39 years, and with skin phototype-II and -III
Key exclusion criteria
1)anti-oxidative products and supplements including vitamin c, CoQ10, polyphenol extracts such as grape seeds and green tea
2)subjects with skin trouble including atopic dermatitis and foods allergy
3)subjects with serious diseases such as diabetes, liver disease, kidney disease, heart disease
4)subjects with a medical condition requiring active management
5)subjects who wish to become pregnant during lactation, pregnancy or during the study period
6)subjects with irregular menstruation, those whose skin condition changes dramatically due to menstruation
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Otake |
| Middle name | |
| Last name | Yasuyuki |
Organization
Asahi Breweries Co Ltd
Division name
Fundamental Research Laboratory
Zip code
302-0106
Address
1-21 Midori 1-chome, Moriya, Ibaraki
TEL
0297-46-1504
yasuyuki.otake@asahibeer.co.jp
Public contact
Name of contact person
| 1st name | Shoji |
| Middle name | |
| Last name | Toshihiko |
Organization
Asahi Breweries Co Ltd
Division name
Fundamental Research Laboratory
Zip code
302-0106
Address
1-21 Midori 1-chome, Moriya, Ibaraki
TEL
0297-46-1504
Homepage URL
toshihiko.shoji@asahibeer.co.jp
Sponsor or person
Institute
Others/Dermis Research Center
Institute
Department
Personal name
Funding Source
Organization
Asahi Breweries 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
Asahi Breweries Co Ltd
Address
1-21 Midori 1-chome, Moriya, Ibaraki
Tel
0297-46-1504
toshihiko.shoji@asahibeer.co.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
18372
Org. issuing International ID_1
Dermis Research Center
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 12 | Month | 31 | Day |
Related information
URL releasing protocol
https://rd.asahigroup-holdings.com/research/report/23.html
Publication of results
Unpublished
Result
URL related to results and publications
https://rd.asahigroup-holdings.com/research/report/23.html
Number of participants that the trial has enrolled
65
Results
After UV-irradiation with 1.5 MED, changes in melanin value, L value, and erythema value over time were investigated. In each group, the erythema value, melanin value, and L value significantly increased after UV irradiation, but no difference was observed between the groups.
Results date posted
| 2020 | Year | 02 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
AP Low-dose group (n=21)
Age 34.2 4.29 y
MED 5323.7 478.0 mJ/cm2
AP high-dose group (n=20)
Age 35.2 3.89 y
MED 5471.1 499.7 mJ/cm2
Placebo group (n=18)
Age 34.1 4.08 y
MED 5247.0 531.7 mJ/cm2
Participant flow
Three subjects dropped out for personal reasons and three subjects failed to attend study visit for the measurement.
Adverse events
not detect
Outcome measures
melanin value, L value, erythema value
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2007 | Year | 01 | Month | 27 | Day |
Date of IRB
| 2007 | Year | 01 | Month | 26 | Day |
Anticipated trial start date
| 2007 | Year | 01 | Month | 29 | Day |
Last follow-up date
| 2007 | Year | 04 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 02 | Month | 26 | Day |
Last modified on
| 2020 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045158
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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