UMIN-CTR Clinical Trial

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 adults
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluation of fibroid properties of hair, skin water content, transepidermal water loss, lipid content, analysis skin date by VISIA,lipid RNA, swelling measurment and analysis of microbiome.
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	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	5-aminolevulinic acid(5-ALA)suppliment, 3 months
Interventions/Control_2	suppliment contain 5-aminolevulinic acid(5-ALA) and other plant extracts, 3 months
Interventions/Control_3	Placebo, 3 months
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	59 years-old >
Gender	Male and Female
Key inclusion criteria	1.Healthy Japanese male and female aged 20-59 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	90

Research contact person
Name of lead principal investigator	1st name Len 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
Email	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
Email	yogawa@milbon.com

Sponsor
Institute	Milbon Co., Ltd.
Institute
Department

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
Email	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	2023 Year 06 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	90
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	2022 Year 05 Month 20 Day
Date of IRB	2022 Year 06 Month 10 Day
Anticipated trial start date	2022 Year 06 Month 22 Day
Last follow-up date	2022 Year 10 Month 14 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 11 Month 18 Day
Last modified on	2022 Year 11 Month 18 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056375