UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042097 |
|---|---|
| Receipt number | 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 09:16:23 |
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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
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
k_masuda@mail.souken-r.com
Sponsor or person
Institute
Shiba Palace Clinic
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048002
