UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025920 |
|---|---|
| Receipt number | R000029781 |
| Scientific Title | 8-week study of supplement |
| Date of disclosure of the study information | 2017/01/31 |
| Last modified on | 2018/12/05 17:37:01 |
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Basic information
Public title
8-week study of supplement
Acronym
Effect of piceatannol on skin: a randomized controlled trial
Scientific Title
8-week study of supplement
Scientific Title:Acronym
Effect of piceatannol on skin: a randomized controlled trial
Region
| Japan |
Condition
Condition
Dry skin
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the effects of piceatannol supplementation on skin
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measurement of skin condition (measurement time: 0,4,8 weeks after ingestion of supplement)
Key secondary outcomes
Visual analog scale (measurement time: 0,4,8 weeks after ingestion of supplement)
SF-36v2 score (measurement time: 0,4,8 weeks after ingestion of supplement)
Measurement of microflora (measurement time: 0,4 weeks after ingestion of supplement)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Piceatannol group:
Duration: 8 weeks
Test material:supplement containing piceatannol (capsules)
2 capsules per day
Interventions/Control_2
Placebo group:
Duration: 8 weeks
Test material: placebo(capsules)
2 capsules per day
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
| 35 | years-old | <= |
Age-upper limit
| 55 | years-old | > |
Gender
Female
Key inclusion criteria
Healthy female from 35 to 55 years old who is troubled by dry skin
Key exclusion criteria
1. Subjects who take medicine with chronic diseases.
2. Subjects with atopic dermatitis or chronic dermatitis.
3. Subjects who have possibilities for excessive sunburn.
4. Subjects who have severe allergy to foods and medicine.
5. Subjects who are pregnant or lactating, or planned to become pregnant in the near future.
6. Subjects who have a history of serious disorder.
7. Subjects who are under treatment by physician.
8. Subjects with severe anemia.
9. Subjects who have possibilities for lifestyle change during this study.
10. Subjects who have allergy to cosmetics and ingredients.
11. Subjects who are participating in other clinical studies.
12. Subjects who are judged as unsuitable for this study by the investigator.
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiko Sai |
Organization
MORINAGA & CO., LTD.
Division name
Health and Wellness Headquarters
Zip code
Address
2-1-1, SHIMOSUEYOSHI, TSURUMI-KU, YOKOHAMA
TEL
045-571-2982
m-sai-ia@morinaga.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroko Uchida |
Organization
MORINAGA & CO., LTD.
Division name
Health and Wellness Headquarters
Zip code
Address
2-1-1, SHIMOSUEYOSHI, TSURUMI-KU, YOKOHAMA
TEL
045-571-2982
Homepage URL
h-uchida-ji@morinaga.co.jp
Sponsor or person
Institute
MORINAGA & CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
MORINAGA & 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
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
| 2017 | Year | 01 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2017 | Year | 01 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 31 | 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
| 2017 | Year | 01 | Month | 31 | Day |
Last modified on
| 2018 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029781
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
