UMIN-CTR Clinical Trial

Basic information
Public title	Observational study to elucidate the relationship between nutrients in the body and skin condition
Acronym	Observational study to elucidate the relationship between nutrients in the body and skin condition
Scientific Title	Observational study to elucidate the relationship between nutrients in the body and skin condition
Scientific Title:Acronym	Observational study to elucidate the relationship between nutrients in the body and skin condition
Region	Japan

Condition
Condition	N/A
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Identify relationship between nutrients and skin condition.
Basic objectives2	Others
Basic objectives -Others	Identify relationship between nutrients and skin condition.
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	skin measurements
Key secondary outcomes	image data biological components VAS questionnaire BDHQ

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	45 years-old >=
Gender	Female
Key inclusion criteria	Those who are willing to participate in the study. (1) Those who have expressed their willingness to participate in the study, have understood the explanation, and have given written consent to participate in the study. (2) Healthy Japanese women between the ages of 35 and 45 who do not violate the exclusion criteria. (2) Healthy Japanese females between the ages of 35 and 45 who do not violate the exclusion criteria (3) No significant skin irritation, scars, or sunburn on the cheeks or upper arms (4) Regular meals (3 meals a day) for 3 days prior to the test, including the day of the test. (5) Refrain from drinking alcohol the day before and the day of urine collection. (6) Refrain from using supplements (including nutritional drinks) and medicines for 3 months before the test. (7) Those who can consent to urine and blood collection. (8) Those who can consent to the collection of stratum corneum tape from the cheek and upper arm. (9) Those who are able to fill out the consent form, questionnaire, and daily log.
Key exclusion criteria	(1) Those who are currently using skin beautifying and dieting supplements, collagen supplements, and medicines (including hyrdids and zinc ointments). (2) Those who are undergoing hospital visits or medication. (3) Those who have chronic diseases such as cancer, high blood pressure, diabetes, kidney failure, etc. (4) Those who have food allergies (5) Those who smoke on a daily basis (6) Those who are pregnant or planning to become pregnant, and those who are breast-feeding (7) Those who are currently participating in a study in which other foods or drugs are ingested or cosmetics or drugs are applied. Those who have participated in beauty treatments within the past three months. (8) Those with a history of visiting a cosmetic dermatologist within the past three months (9) Those who are scheduled to receive a new coronavirus vaccine within one week prior to the study. (10) Others who are judged as inappropriate by the principal investigator or the physician in charge of the study.
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Osamu Middle name Last name Ueda
Organization	SHISEIDO CO., LTD.
Division name	MIRAI Technology InstituteFrontier Business R&D
Zip code	220-0011
Address	1-2-11, Takasima, Nishi-ku, YOKOHAMA
TEL	070-3763-2823
Email	osamu.ueda@shiseido.com

Public contact
Name of contact person	1st name Kanako Middle name Last name Sakurai
Organization	Inforward, Inc
Division name	Ebisu Skin Research Center
Zip code	150-0013
Address	1-11-2 Ebisu, Shibuya, Tokyo 1500013, Japan
TEL	03-5447-6411
Homepage URL
Email	sakurai@inforward.co.jp

Sponsor
Institute	SHISEIDO CO., LTD.
Institute
Department

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	General Incorporated Association Crinical Research Review Center
Address	2972-8-603, Ishikawa-machi Hachioji-shi,Tokyo,192-0032,JAPAN
Tel	090-3547-6398
Email	crrctakashima@kpd.biglobe.ne.jp

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 12 Month 31 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	2021 Year 09 Month 29 Day
Date of IRB	2021 Year 09 Month 29 Day
Anticipated trial start date	2021 Year 11 Month 08 Day
Last follow-up date	2021 Year 12 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Descriptive study. Recruitment from registered monitors for the recruitment period outsourced by the study contractor. After completion of recruitment, screening will be conducted to finalize eligibility, and a target number of eligible participants will be enrolled in the study.

Management information
Registered date	2021 Year 10 Month 29 Day
Last modified on	2021 Year 10 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052221