UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024478 |
|---|---|
| Receipt number | R000028173 |
| Scientific Title | The exploratory study of plant polyphenols for the effect to skin. |
| Date of disclosure of the study information | 2016/10/26 |
| Last modified on | 2016/10/19 11:44:37 |
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Basic information
Public title
The exploratory study of plant polyphenols for the effect to skin.
Acronym
The exploratory study of plant polyphenols for the effect to skin.
Scientific Title
The exploratory study of plant polyphenols for the effect to skin.
Scientific Title:Acronym
The exploratory study of plant polyphenols for the effect to skin.
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the effect to skin of plant polyphenols.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skin condition score 4, 8, 12 weeks after intervention
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Subjects will take the food containing plant polyphenols for 12 weeks.
Interventions/Control_2
Subjects will take the food not containing plant polyphenols 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
Female
Key inclusion criteria
1) 30 years of age or older, and less than 60 years of age.
2) Subjects who care about skin.
Key exclusion criteria
1)Use of medicines for skin treatment.
2)Subjects with atopic dermatitis
3)Subjects with abnormality on the face skin.
4)Subjects with serious disease
5)Subjects in pregnancy, lactation and scheduled pregnancy period.
6)Investigator's judgment for other reason
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuhiro Zeida |
Organization
Suntory Global Innovation Center LTD.
Division name
Research Institute
Zip code
Address
8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto 619-0284
TEL
050-3182-0464
Mitsuhiro_Zeida@suntory.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuko Fukui |
Organization
Suntory Global Innovation Center LTD.
Division name
Research Institute
Zip code
Address
8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto 619-0284
TEL
050-3182-0456
Homepage URL
Yuko_Fukui@suntory.co.jp
Sponsor or person
Institute
Suntory Global Innovation Center LTD.
Institute
Department
Personal name
Funding Source
Organization
None
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
Address
Tel
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 | 10 | Month | 26 | 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
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
Preinitiation
Date of protocol fixation
| 2016 | Year | 09 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 10 | Month | 26 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 10 | Month | 19 | Day |
Last modified on
| 2016 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028173
