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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025920
Receipt No. R000029781
Scientific Title 8-week study of supplement
Date of disclosure of the study information 2017/01/31
Last modified on 2018/12/05

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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
Email 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
Email h-uchida-ji@morinaga.co.jp

Sponsor
Institute MORINAGA & CO., LTD.
Institute
Department

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
Email

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
URL(English) https://upload.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
Registered date File name


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