UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053888 |
|---|---|
| Receipt number | R000061390 |
| Scientific Title | Effectiveness test on hair and skin ingesting health foods |
| Date of disclosure of the study information | 2024/09/01 |
| Last modified on | 2024/03/18 14:50:29 |
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Basic information
Public title
Effectiveness test on hair and skin ingesting health foods
Acronym
Effectiveness test on hair and skin ingesting health foods
Scientific Title
Effectiveness test on hair and skin ingesting health foods
Scientific Title:Acronym
Effectiveness test on hair and skin ingesting health foods
Region
| Japan |
Condition
Condition
Healthy Japanese subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigating the effects of health foods on skin and hair
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluation of fibroid properties of hair, skin water content, transepidermal water loss, lipid content, analysis skin date by VISIA,lipid RNA, blood flow measurement and analysis of microbiome(4w,8w,12w).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
5
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
suppliment contain plant extracts, 12 weeks
Interventions/Control_2
suppliment contain plant extracts, 12 weeks
Interventions/Control_3
suppliment contain plant extracts, 12 weeks
Interventions/Control_4
suppliment contain plant extracts, 12 weeks
Interventions/Control_5
Placebo, 12 weeks
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
| 55 | years-old | > |
Gender
Female
Key inclusion criteria
1.Healthy Japanese female aged 20-55 years at the time of giving informed consent
2. Individuals who has freely given consent and has understood the purpose of study
Key exclusion criteria
-Subjects with skin diseases such as atopic dermatitis, psoriasis and severe acne
-Subjects seemed inappropriate to participate in this study by the principle investigator
-Subjects who have medical treatment or take some medicine for their scalp or facial skin
-Subjects who are pregnant, breast-feeding, and planning to become pregnant
- Subjects who are currently taking medications and supplements
-Subject who work night shifts or day and night shifts
-Subjects who are judged as ineligible to participate in the study by the physician
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Ren |
| Middle name | |
| Last name | Ito |
Organization
Milbon Co., Ltd.
Division name
Development Headquarters
Zip code
534-0015
Address
2-3-35, Zengenji-cho, Miyakojima-ku, Osaka-city, Osaka, 534-0015, JAPAN
TEL
+81-6-6925-8010
lito@milbon.com
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Ogawa |
Organization
Milbon Co., Ltd.
Division name
Development Headquarters
Zip code
534-0015
Address
2-3-35, Zengenji-cho, Miyakojima-ku, Osaka-city, Osaka, 534-0015, JAPAN
TEL
+81-6-6925-8010
Homepage URL
yogawa@milbon.com
Sponsor or person
Institute
Milbon Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Milbon Co., Ltd.
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
Milbon Co., Ltd.
Address
2-3-35, Zengenji-cho, Miyakojima-ku, Osaka-city, Osaka, JAPAN
Tel
+81-6-6925-8010
yogawa@milbon.com
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
| 2024 | Year | 09 | Month | 01 | 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
108
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
| 2023 | Year | 10 | Month | 17 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 26 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 26 | Day |
Last follow-up date
| 2024 | Year | 01 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 03 | Month | 18 | Day |
Last modified on
| 2024 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061390
