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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000042982 |
Receipt No. | R000049070 |
Scientific Title | Skin condition and face line improvement effect by facial equipment"M18": single-blind |
Date of disclosure of the study information | 2021/01/14 |
Last modified on | 2021/01/12 |
Basic information | ||
Public title | Skin condition and face line improvement effect by facial equipment"M18" | |
Acronym | M18 trial | |
Scientific Title | Skin condition and face line improvement effect by facial equipment"M18": single-blind | |
Scientific Title:Acronym | Skin condition and face line improvement effect by facial equipment"M18" | |
Region |
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Condition | ||
Condition | Healthy adult woman | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | Comparison of changes in skin condition and face line angle due to use of test article |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | skin condition measurement(before use, immediately after use, 4 weeks later) |
Key secondary outcomes |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Open -but assessor(s) are 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 | Only one side of the face,Using test article for 4 consecutive weeks | ||
Interventions/Control_2 | The other side of the face, no using test article for 4 consecutive weeks | ||
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.Subjects who want to care for sagging face, sagging cheeks, and dry skin
2.Subjects whose wrinkle class in the outer corner of eye is 1 to 3 3.Subjects who cannot relax with getting tired |
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Key exclusion criteria | 1. Subjects with cosmetic allergy or metal allergy
2. Subjects who are pregnant or breastfeeding 3. Subjects who have inflammation or wound on their face 4. Subjects with sensitive skin 5. Subjects who are judged as unsuitable for the study by the investigator for the other reason |
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Target sample size | 16 |
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 | 0364574666 | ||||||
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 | 0364574666 | ||||||
Homepage URL | |||||||
info@yakujihou.org |
Sponsor | |
Institute | Japan Clinical Trial Association |
Institute | |
Department |
Funding Source | |
Organization | YA-MAN 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 | Preinitiation | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
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=R000049070 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |