UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049095 |
|---|---|
| Receipt number | R000055915 |
| Scientific Title | Study to verify the effect of continuous intake of test foods on skin condition: single group open study |
| Date of disclosure of the study information | 2022/10/05 |
| Last modified on | 2023/01/06 13:22:34 |
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Basic information
Public title
Study to verify the effect of continuous consumption of the test food on improving skin condition
Acronym
Skin condition improvement efficacy verification tests
Scientific Title
Study to verify the effect of continuous intake of test foods on skin condition: single group open study
Scientific Title:Acronym
Skin condition improvement efficacy validation study: single group open study
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the study is to examine the effect of the test food on the skin condition after 6 weeks of continuous consumption.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skin lightness, hue, saturation
Key secondary outcomes
Dark circles status score, skin condition questionnaire, stratum corneum moisture content, skin viscoelasticity (R2, R5, R7), skin texture
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
Consume the test food once a day after dinner with water or lukewarm water for 6 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
| 40 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Japanese nationals
2. healthy women over 40 and under 65 years of age
3. who are concerned about dark circles under the eyes
Key exclusion criteria
1. Persons with skin diseases such as atopic dermatitis, contact dermatitis or skin hypersensitivity
2. Persons taking medication or applying medication externally to the study site that is thought to affect the study within 2 weeks of the start of the study
3. Persons with scars or sunburn at the test site that would interfere with the determination
4. Persons with a history of treatment for malignancy, heart failure or myocardial infarction
5. Persons under treatment for the following chronic diseases
Atrial fibrillation, arrhythmia, liver disorders, renal disorders, cerebrovascular disorders, rheumatism, diabetes, dyslipidaemia, hypertension and other chronic diseases
6. Persons who regularly use pharmaceuticals (including herbal medicines), foods for specified health uses, functional foods, health foods and supplements
7. Persons with allergies (to medicines and test food related foods)
8. Persons who are pregnant, lactating or intend to become pregnant during the study period
9. Persons who are participating in a human trial at the start of the study or who are expected to participate in another human trial during the planned duration of the study
10. Any other person who is deemed by the investigator to be unsuitable for the study
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Igari |
Organization
Daiwa Pharmaceutical Co., Ltd.
Division name
Research and Development Department
Zip code
154-0024
Address
1-16-19 Sangenjaya, Setagaya-ku, Tokyo, Japan
TEL
03-5430-4050
igari@daiwa-pharm.com
Public contact
Name of contact person
| 1st name | Masao |
| Middle name | |
| Last name | Matsuoka |
Organization
M&I Science CORP.
Division name
Clinical Development Department
Zip code
531-0071
Address
NAKATSUGRAND Bld.10F, 1-17-26, Nakatsu, Kita-ku, Osaka-Shi, Osaka, Japan
TEL
06-7878-6780
Homepage URL
m.matsuoka@mis21.co.jp
Sponsor or person
Institute
M&I Science CORP.
Institute
Department
Personal name
Funding Source
Organization
Daiwa 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
NISHI-UMEDA Clinic for Asian Medical Collaboration Clinical Research Institutional Review Board
Address
West Umeda Building 3F 3-3-45 Umeda Kita-ku Osaka Japan, 530-0001
Tel
06-4797-5660
jimukyoku@amc-clinc.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 | 10 | Month | 05 | 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 | 08 | Month | 19 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 22 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 06 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 17 | Day |
Date of closure to data entry
| 2022 | Year | 12 | Month | 16 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 20 | Day |
Date analysis concluded
| 2023 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 10 | Month | 03 | Day |
Last modified on
| 2023 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055915
