UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050245 |
|---|---|
| Receipt number | R000056650 |
| Scientific Title | Effects of a Test Food for Improvement of Skin Function |
| Date of disclosure of the study information | 2023/02/07 |
| Last modified on | 2023/08/10 17:26:23 |
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Basic information
Public title
Effects of a Test Food for Improvement of Skin Function
Acronym
Effects of a Test Food for Improvement of Skin Function
Scientific Title
Effects of a Test Food for Improvement of Skin Function
Scientific Title:Acronym
Effects of a Test Food for Improvement of Skin Function
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to examine effects of a test food on improvement of skin function.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
*Skin measurements
[1] Skin moisture content (Week 0, Week 2, Week 4)
[2] Transepidermal water loss (Week 0, Week 4)
[3] Colour difference (Week 0, Week 4)
[4] Image analysis by VISIA (Week 0, Week 2, Week 4)
[5] Collagen Score (Week 0, Week 4)
[6] Observation for skin condition by dermatologists (Week 0, Week 2, Week 4)
Key secondary outcomes
[1] Capillary evaluation by capillary scope (Week 0, Week 4)
[2] Visual Analogue Scale(Week 0, Week 2, Week 4)
[3] Questionnaires at the end of the study (Week 4)
*Safety
[1] Blood pressure, pulsation (Week 0, Week 2, Week 4)
[2] Doctor's questions (Week 0, Week 2, Week 4)
[3] Adverse events: number of cases and expression rate of adverse events (Week 2, Week 4)
[4] 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
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Test product (2 times in a day; 4 weeks).
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
| 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 concerned about dryness and dullness of the skin.
[4] Individuals who suffer from coldness of the body or limbs.
[5] Individuals who have a stable menstrual cycle and few complaints due to menstruation, or who have undergone menopause (more than 6 months since the last menstrual period) and are in a stable health condition.
[6] Individuals whose written informed consent has been obtained after explanation of this study.
[7] Individuals who can have an examination on a designated check day.
[8] Individuals judged appropriate for the study by the principal.
Key exclusion criteria
[1] Individuals using medical products.
[2] Individuals with skin disease symptoms such as atopic dermatitis.
[3] Individuals who have wounds or inflammation in the evaluation site and have experience of aesthetic medicine.
[4] Individuals who received aesthetic medicine other than the measurement site or hormone replacement therapy within one year before the preliminary examination.
[5] Individuals who used a drug to treat a disease in the past 1 month.
[6] Individuals who have a history of serious hepatopathy, kidney damage, heart disease, hematological and blood disease.
[7] Individuals who contract or have a history of serious gastrointestinal disease.
[8] Individuals with anemia.
[9] Individuals whose BMI is over 30 kg/m2.
[10] Individuals with irregular bowel habits (constipation, loose stools, and diarrhea).
[11] Individuals who currently or within the past 3 months have a habit of taking foods for specified health uses, foods with function claims, health foods, and supplements, or plan to take them during the test period.
[12] Individuals who use cosmetics that have strong moisturizing effects, wrinkles, and whitening effects (such as serum sealer patches).
[13] Individuals who are or are possibly pregnant, or are lactating.
[14] Individuals who excessively take alcohol (expressed in an amount of alcohol: over 30g/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 are likely to develop seasonal or perennial allergic symptoms during the study period and who may use pharmaceuticals (eye drops and nasal drops are acceptable).
[19] Individuals who neglect skin care.
[20] Individuals who participated in other clinical studies in the past 3 months.
[21]Individuals judged inappropriate for the study by the principal.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Kazutake |
| Middle name | |
| Last name | Fukada |
Organization
ROHTO Pharmaceutical Co., Ltd.
Division name
Internal Medicine & Food Development Dept.
Zip code
544-8666
Address
1-8-1 Tatsumi Nishi, Ikuno-ku, Osaka City, Osaka 544-8666, JAPAN
TEL
+81-6-6758-9848
fukada@rohto.co.jp
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
ROHTO Pharmaceutical 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
Clinical Research Ethics Review Board, Rohto Pharmaceutical Co., Ltd.
Address
1-8-1 Tatsumi Nishi, Ikuno-ku, Osaka City, Osaka 544-8666, JAPAN
Tel
+81-6-6758-6925
rohtoirb@rohto.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
| 2023 | Year | 02 | Month | 07 | 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
| 2022 | Year | 11 | Month | 18 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 16 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 02 | Month | 06 | Day |
Last modified on
| 2023 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056650
