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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000034040 |
Receipt No. | R000038807 |
Scientific Title | Effect of prevent wrinkles by cosmetic gel cream use |
Date of disclosure of the study information | 2018/09/11 |
Last modified on | 2020/03/26 |
Basic information | ||
Public title | Effect of prevent wrinkles by cosmetic gel cream use | |
Acronym | Effect of prevent wrinkles by cosmetic gel cream use | |
Scientific Title | Effect of prevent wrinkles by cosmetic gel cream use | |
Scientific Title:Acronym | Effect of prevent wrinkles by cosmetic gel cream use | |
Region |
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Condition | ||
Condition | Healthy adult female | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | Influence to the wrinkles when an adult female used cosmetic gel cream for 4 weeks, is estimated |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Comparison of wrinkles condition before starting use of test article and 4 weeks after use |
Key secondary outcomes |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Self control |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 1 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | Using test cosmetic gel cream for 4 consecutive 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 |
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Age-upper limit |
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Gender | Female | |||
Key inclusion criteria | Subjects whose wrinkle class in the outer corner is 1 to 3 | |||
Key exclusion criteria | 1. Subjects with cosmetic allergies
2. Subjects who are pregnant or lactating 3. Subjects with inflamed or scraped skin on face 4. Subjects who are judged as unsuitable for the study by the investigator for the other reason |
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Target sample size | 12 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Japan Clinical Trial Association | ||||||
Division name | N.A. | ||||||
Zip code | 1600022 | ||||||
Address | 5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo | ||||||
TEL | 0363020593 | ||||||
info@yakujihou.org |
Public contact | |||||||
Name of contact person |
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Organization | Japan Clinical Trial Association | ||||||
Division name | N.A. | ||||||
Zip code | 1600022 | ||||||
Address | 5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo | ||||||
TEL | 0363020593 | ||||||
Homepage URL | |||||||
info@yakujihou.org |
Sponsor | |
Institute | Japan Clinical Trial Association |
Institute | |
Department |
Funding Source | |
Organization | Madre:X 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 | Institutional Review Board of Pharmaceutical Law Wisdoms |
Address | 5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo |
Tel | 0364574911 |
master@yakujihou.net |
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 | |
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 |
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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://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038807 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |