UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045911 |
|---|---|
| Receipt number | R000052221 |
| Scientific Title | Observational study to elucidate the relationship between nutrients in the body and skin condition |
| Date of disclosure of the study information | 2023/12/31 |
| Last modified on | 2021/10/29 08:39:11 |
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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
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
sakurai@inforward.co.jp
Sponsor or person
Institute
SHISEIDO CO., LTD.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052221
