UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046489 |
|---|---|
| Receipt number | R000052880 |
| Scientific Title | Study for the Effects of a Test Food on Skin Function. |
| Date of disclosure of the study information | 2022/01/10 |
| Last modified on | 2022/11/04 15:22:19 |
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Basic information
Public title
Study for the Effects of a Test Food on Skin Function.
Acronym
Study for the Effects of a Test Food on Skin Function.
Scientific Title
Study for the Effects of a Test Food on Skin Function.
Scientific Title:Acronym
Study for the Effects of a Test Food on Skin Function.
Region
| Japan |
Condition
Condition
N/A(healthy adults)
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study examines effects of a test food on skin function.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
[1]Transepidermal water loss (Screening, Week 0, Week 6, Week 12).
Key secondary outcomes
*Secondary indexes
[1]Skin moisture content (Screening, Week 0, Week 6, Week 12).
[2]Skin viscoelasticity (Screening, Week 0, Week 6, Week 12).
[3]Collagen Score (Screening, Week 0, Week 6, Week 12).
[4]Observation for skin condition by dermatologists (Screening, Week 0, Week 6, Week 12).
[5]Visual Analogue Scale (Week 0, Week 6, Week 12).
*Safety
[1]Doctor's questions (Screening, Week 0, Week 6, Week 12).
[2]Subject's diary (From the first day of ingestion of a test material to the last day of the test).
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
Oral intake of the test food (1 capsule in a day; 12 weeks).
Interventions/Control_2
Oral intake of the placebo food (1 capsule in a day; 12 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
| 30 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Female
Key inclusion criteria
[1]Healthy Japanese females aged 30-59 years.
[2]Individuals who are healthy and have no chronic physical disease including skin disease.
[3]Individuals who are aware of skin dryness.
[4]Individuals whose written informed consent has been obtained after explanation of this study.
[5]Individuals who can have an examination on a designated check day.
[6]Individuals judged appropriate for the study by the principal.
Key exclusion criteria
[1]Individuals using medical products.
[2]Individuals with skin disease, such as atopic dermatitis.
[3]Individuals with strange skin conditions at measurement points.
[4]Individuals who used a drug to treat a disease in the past 1 month (except temporal usage for pollenosis).
[5]Individuals who have a history of serious hepatopathy, kidney damage, heart disease, hematological and blood disease.
[6]Individuals who contract or have a history of serious gastrointestinal disease.
[7]Individuals with serious anemia.
[8]Individuals whose BMI is over 30 kg/m2.
[9]Individuals who are sensitive to test product or other foods, and medical products.
[10]Individuals who had a habit to ingest health-promoting foods, or supplements containing similar composition with a test food in the past 3 months or will ingest those foods during the test period.
[11]Individuals who have a habit to ingest health-promoting foods, or supplements containing similar composition with a test food in the past 3 months or will ingest those foods during the test period.
[12]Individuals who have a habit to use drug claiming to improve skin condition in the past 3 months.
[13]Individuals who are or are possibly pregnant, or are lactating.
[14]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60mg/day).
[15]Individuals who are patient or have a history of psychiatric disease.
[16]Individuals who are a smoker.
[17]Individuals with possible changes of life style during the test period.
[18]Individuals who will develop seasonal allergy symptoms like hay fever and use a drug.
[19]individuals who neglect skin care.
[20]Individuals who will get sunburned during the test period.
[21]Individuals who had been conducted an operation or beauty treatment on the test spot.
[22]Individuals who participated in other clinical studies in the past 3 months.
[23]Individuals judged inappropriate for the study by the principal.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Ono |
Organization
Ueno-Asagao Clinic
Division name
Head
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
+81-3-6240-1162
info@ueno-asagao.clinc
Public contact
Name of contact person
| 1st name | Ryoma |
| Middle name | |
| Last name | Shimizu |
Organization
TES Holdings Co., Ltd.
Division name
Administrative Department of Clinical Trials
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
+81-3-6801-8480
Homepage URL
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
TES Holdings Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Maruzen Pharmaceuticals Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ueno-Asagao Clinic Ethical Review Committee
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel
+81-3-6240-1162
jimukyoku@tes-h.co.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
| 2022 | Year | 01 | Month | 10 | 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
Completed
Date of protocol fixation
| 2021 | Year | 12 | Month | 07 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 09 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 23 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 12 | Month | 27 | Day |
Last modified on
| 2022 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052880
