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UMIN-CTR Clinical Trial |
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Name | UMIN ID |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000046645 |
Receipt No. | R000053186 |
Scientific Title | Study of the effect of improving wrinkles at the corners of the eyes by using skin care cosmetics |
Date of disclosure of the study information | 2022/01/15 |
Last modified on | 2022/07/08 |
Basic information | ||
Public title | Study of the effect of improving wrinkles at the corners of the eyes by using Asakado skin care cosmetics | |
Acronym | Study of the effect of improving wrinkles at the corners of the eyes by using Asakado skin care cosmetics | |
Scientific Title | Study of the effect of improving wrinkles at the corners of the eyes by using skin care cosmetics | |
Scientific Title:Acronym | Study of the effect of improving wrinkles at the corners of the eyes by using skin care cosmetics | |
Region |
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Condition | ||
Condition | Healthy volunteer | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To verify the effect of skin care cosmetics on improving wrinkles at the corners of the eyes |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | evaluation of wrinkles(JCSS) |
Key secondary outcomes | Skin elasticity evaluation, evaluation by questionnaire |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | No treatment |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | apply test cosmetics | |
Interventions/Control_2 | Do not apply test cosmetics | |
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 |
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Age-upper limit |
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Gender | Female | |||
Key inclusion criteria | [1]Japanese females aged 35-54 years
[2]Individuals who do not have chronic physical illnesses, including skin disorders [3]Individuals whose wrinkles at the corners of the eyes are judged to be wrinkle great 1-3 [4]Individuals who have wrinkles at the corners of the eyes that are almost symmetrical [5]Individuals whose written informed consent has been obtained [6]Individuals who can come to the designated examination date and receive the examination [7]Individuals judged appropriate for the study by the principal |
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Key exclusion criteria | Individuals (who)
[1]using medical products [2]under treatment or with history of mental disorders, sleep disorders, hypertension, diabetes, lipid metabolism abnormality, or other serious disorders [3]with history of serious diseases (hepatic, renal, cardiovascular, respiratory, hematologic, etc.) [4]have a history and/or contract digestive disease [5]with a history of cosmetic troubles or current medical history [6]with skin symptoms such as atopic dermatitis, perioral dermatitis, and rosacea-like dermatitis [7]with experience in cosmetology and aesthetic medicine that affect the measuring area [8]have performed or received the following acts within the past 3 months a.Hormone replacement therapy b.Use of cosmetics (eye cream, sealer, patch, etc.) that have strong moisturizing effect and wrinkle-related effect c.Regular use of medicines, quasi-drugs, foods and drinks for the purpose of improving the skin [9]have an inflammation or a scar on a measuring area [10]receiving/received medical drug treatment for the past 1 month except for temporary relief medication for headache, menstrual pain, common cold, etc. [11]drink more than 60g/day on average in terms of pure alcohol [12]with possible changes of life style during test periods [13]will develop seasonal allergy symptoms, such as pollinosis, use an anti-allergic drug [14]can't avoid direct sunlight exposure, such as sunburn, during test periods. [15]are or are possibly pregnant, or are breastfeeding [16]are participating and/or had participated in other clinical studies within the last 3 months [17]are judged as not appropriate to this study by a responsible doctor |
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Target sample size | 34 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Faculty of Life and Medical Sciences,Doshisha University | ||||||
Division name | Anti-Aging Medical Research Center | ||||||
Zip code | 6100394 | ||||||
Address | 1-3 Tatara Miyakodani,Kyotanabe City,Kyoto | ||||||
TEL | 0774-65-6394 | ||||||
yyonei@mail.doshisha.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | TES Holdings Co., Ltd. | ||||||
Division name | Department of Clinical Trial | ||||||
Zip code | 1100015 | ||||||
Address | 6F,Kairaku Bldg,2-7-5 Higashi-Ueno,Taitou-ku,Tokyo | ||||||
TEL | 03-6801-8400 | ||||||
Homepage URL | |||||||
info@tes-h.co.jp |
Sponsor | |
Institute | Anti-Aging Bank Co.,Ltd. |
Institute | |
Department |
Funding Source | |
Organization | NABOCULcosmetics.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 | Society of Glycative Stress Research |
Address | 5F-11,Musashino Bldg,2-13-10 Shinjuku,Shinjuku-ku,Tokyo |
Tel | 03-6709-8842 |
rinri-glycativestress@antiaging-bank.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 | うえのあさがおクリニック(東京都) |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | 34 |
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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
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=R000053186 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |