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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000042097
Receipt No. R000048002
Scientific Title Evaluation study for intake of test food containing Proteoglycan on effect in skin moisture
Date of disclosure of the study information 2021/10/14
Last modified on 2021/10/14

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Basic information
Public title Evaluation study for intake of test food containing Proteoglycan on effect in skin moisture
Acronym Evaluation study for intake of test food containing Proteoglycan on effect in skin moisture
Scientific Title Evaluation study for intake of test food containing Proteoglycan on effect in skin moisture
Scientific Title:Acronym Evaluation study for intake of test food containing Proteoglycan on effect in skin moisture
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect in skin moisture by taking the test food containing Proteoglycan
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Water content of stratum corneum, Transepidermal water loss (0-3-6w)
Key secondary outcomes questionnaire (0-3-6w)

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 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Intake the active food for 6 weeks
Interventions/Control_2 Intake the placebo food for 6 weeks
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
20 years-old <=
Age-upper limit
59 years-old >=
Gender Male and Female
Key inclusion criteria 1) Japanese males and females aged 20 to 59 years old
2) Subjects who are concerned about their dry skin due to air conditioning in their office
Key exclusion criteria 1) Subjects who have sensitive skin or possibility of allergy to the test product
2) Subjects who are currently attending the hospital, taking medical treatments or having dose of medicines
3) Subjects who are pregnant, breast-feeding or have possibility (hope) of pregnancy
4) Subjects who are participating in other clinical trials
5) Subjects with significant abnormality in skin conditions on their test sites (face, neck or shin)
6) Subjects who have possibility of allergy to the ingredient of the test product (salmon)
7) Subjects who are participating in other clinical trials or have participated in them within 3 months before the test
8) Subjects who are using cosmetics containing hyaluronic acid, collagen, ceramide or vitamins or have used them within 1 month before the test
9) Subjects who are taking or plan to take medicines due to hay fever
10) Subjects judged inappropriate for the study by the principal
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Takashi
Middle name
Last name Koikeda
Organization Shiba Palace Clinic
Division name Chair
Zip code 105-0013
Address DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
TEL 03-5408-1590
Email jimukyoku@mail.souken-r.com

Public contact
Name of contact person
1st name Ko
Middle name
Last name Masuda
Organization SOUKEN Co., Ltd
Division name Management Division
Zip code 1050013
Address DaiwaA Hamamatsucho Bldg. 3F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
TEL 0354081555
Homepage URL
Email k_masuda@mail.souken-r.com

Sponsor
Institute Shiba Palace Clinic
Institute
Department

Funding Source
Organization ICHIMARU PHARCOS 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 Shiba Palace Clinic Ethics Review Committee
Address DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
Tel 03-5408-1599
Email shiba_palace@s-palace-clinic.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
2021 Year 10 Month 14 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 50
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
2019 Year 12 Month 25 Day
Date of IRB
2020 Year 01 Month 09 Day
Anticipated trial start date
2020 Year 01 Month 16 Day
Last follow-up date
2020 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 10 Month 13 Day
Last modified on
2021 Year 10 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048002

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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