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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000039612
Receipt No. 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

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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
Email 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
Email toshihiko.shoji@asahibeer.co.jp

Sponsor
Institute Others/Dermis Research Center
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045158

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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