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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | No longer recruiting |
Unique ID issued by UMIN | UMIN000046490 |
Receipt No. | R000052881 |
Scientific Title | Study for the Effects of a Test Food on Skin Function. |
Date of disclosure of the study information | 2022/01/22 |
Last modified on | 2022/01/31 |
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 |
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Condition | ||
Condition | N/A(healthy adults) | |
Classification by specialty |
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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]Skin viscoelasticity (Week 0, Week 8). |
Key secondary outcomes | *Secondary outcomes
[1]Transepidermal water loss (Week 0, Week 8). [2]Skin moisture content (Week 0, Week 8). [3]Collagen Score (Week 0, Week 8). [4]Observation for skin condition by dermatologists (Week 0, Week 8). [5]Visual Analogue Scale (Week 0, Week 8). *Safety [1]Doctor's questions (Week 0, Week 8). [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 | 3 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | Oral intake of the test food A (2 tablets per day; 8 weeks). | |
Interventions/Control_2 | Oral intake of the test food B (2 tablets per day; 8 weeks). | |
Interventions/Control_3 | Oral intake of the placebo (2 tablets per day; 8 weeks). | |
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 |
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Age-upper limit |
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Gender | Female | |||
Key inclusion criteria | [1]Healthy Japanese females aged 40-49 years.
[2]Individuals who are healthy and have no chronic physical disease including skin disease. [3]Individuals who are aware of skin dryness and sagging. [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. |
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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 take 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 use drug claiming to improve skin condition in the past 3 months. [12]Individuals who are or are possibly pregnant, or are lactating. [13]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60mg/day). [14]Individuals who are patient or have a history of psychiatric disease. [15]Individuals who are a smoker. [16]Individuals with possible changes of life style during the test period. [17]Individuals who will develop seasonal allergy symptoms like hay fever and use a drug. [18]individuals who neglect skin care. [19]Individuals who will get sunburned during the test period. [20]Individuals who had been conducted an operation or beauty treatment on the test spot. [21]Individuals who participated in other clinical studies in the past 3 months. [22]Individuals judged inappropriate for the study by the principal. |
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Target sample size | 33 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | TES Holdings Co., Ltd. |
Institute | |
Department |
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 |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Number of participants that the trial has enrolled | |
Results | |
Results date posted | |
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Baseline Characteristics | |
Participant flow | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | No longer recruiting | ||||||
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Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052881 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |