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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000026571 |
Receipt No. | R000030509 |
Scientific Title | Efficacy test of the moisturizer SIR |
Date of disclosure of the study information | 2017/03/28 |
Last modified on | 2019/03/25 |
Basic information | ||
Public title | Efficacy test of the moisturizer SIR | |
Acronym | Efficacy test of the moisturizer SIR | |
Scientific Title | Efficacy test of the moisturizer SIR | |
Scientific Title:Acronym | Efficacy test of the moisturizer SIR | |
Region |
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Condition | |||
Condition | Healthy adults | ||
Classification by specialty |
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Classification by malignancy | Others | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To confirm the moisturizing activity and the mechanism of the active ingredient for healthy skin |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Change of water content, transepidermal water loss, visual score and texture before and after the topical application for 2, 4 and 5weeks |
Key secondary outcomes | Change of cell morphology and the composition of stratum corneum before and after the topical application for 2, 4 and 5weeks |
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 | Apply the formulation including an active ingredient to the one lower leg and the placebo to other lower leg twice daily for 4 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 | Healthy females | |||
Key exclusion criteria | -Subjects with allergy for the skin care product
-Subjects who are pregnant, planning a pregnancy, or breastfeeding - Subjects with a history of skin cancer, having active skin cancer, or who are receiving anti-cancer immunosuppressive treatments or medications -Subjects with a history of immunosuppression/immune deficiency disorders (including (HIV infection or AIDS) or currently using immunosuppressive medications and/or radiation as determined by study documentation One with the plan to receive a medical act during study period -Subjects currently participating in, or scheduled to participate in, any medical trial, consumer study, or any other clinical study on the body during the study period. -Subjects who has caused abnormalities in the test site in a past similar study -Subjects who takes hormone replacement therapy, or are on hormonal birth control -Subjects who takes medical supplies (insulin, steroid, immunosuppressive drug) which may have an influence on the results -Subjects deemed inappropriate to participate in this study by the principle investigator |
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Target sample size | 25 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Kao Corporation | ||||||
Division name | R&D -Core Technology-Biological Science Research | ||||||
Zip code | |||||||
Address | 2606 Akabane, Ichikai-Machi, Haga-Gun, TOCHIGI, 321-3497, JAPAN | ||||||
TEL | 0285-68-2963 | ||||||
murase.takatoshi@kao.co.jp |
Public contact | |||||||
Name of contact person |
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Organization | Kao Corporation | ||||||
Division name | R&D -Core Technology-Biological Science Research | ||||||
Zip code | |||||||
Address | 2606 Akabane, Ichikai-Machi, Haga-Gun, TOCHIGI, 321-3497, JAPAN | ||||||
TEL | 0285-68-2963 | ||||||
Homepage URL | |||||||
murase.takatoshi@kao.co.jp |
Sponsor | |
Institute | Kao Corporation |
Institute | |
Department |
Funding Source | |
Organization | Kao Corporation |
Organization | |
Division | |
Category of Funding Organization | Profit organization |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | Comprehensive Research Group |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
Address | |
Tel | |
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 | Comprehensive Research Group(USA) |
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=R000030509 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |