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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 | UMIN000038552 |
Receipt No. | R000043928 |
Scientific Title | Study to examine the effect of humidity and formulation membrane on skin properties (2) |
Date of disclosure of the study information | 2019/12/01 |
Last modified on | 2019/12/03 |
Basic information | ||
Public title | Study of humidity and membrane for skin properties | |
Acronym | Study of humidity and membrane for skin properties | |
Scientific Title | Study to examine the effect of humidity and formulation membrane on skin properties (2) | |
Scientific Title:Acronym | Study of humidity and membrane for skin properties | |
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 examine the effect for healthy skin properties by staying in the specified humidity environment and by covering the formulation membrane. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | water content, transepidermal water loss, skin color, surface texture and sebum composition |
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 | To stay 6 hours a day in each environments (low and middle humidity). To apply the formulation membrane on only the half face for 6 hours during stay in low humidity environment. | |
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 | 1.Subjects who has become pregnant and breast-feeding or have a possibility of pregnant during the study period.
2.Subjects with illnesses or diseases on their face, especially such as atopic dermatitis, or psoriasis, or severe acne. 3.Subjects who has serious suntan in their faces. 4.Subjects who performs outdoor sport periodically. 5.Subjects who take any OTC or prescription medications, especially anti-inflammation agents, anti-bacterial agents, analgesic agents, hormonal agents, laxative agents, intestinal agents, etc. 6.Subjects who attend the hospital (such as gastrointestinal disease, liver disease, kidney disease, cardiovascular heart disease, skin disease, or poor physical condition). And, panelists for less than one month after attend the hospital. 7.Subjects who has seen in a spa treatment (such as chemical peeling, or laser therapy). And, panelists who has seen in a cosmetic medicine (such as cosmetic surgery, or collagen infusion). 8.Subjects who cannot refrain from facial cleansing on the days of evaluation visits. 9.Subjects who cannot agree with not used mask on the days of evaluation visits. 10.Subjects who are participating or plan to participate in other intervention tests (cosmetics, foods) for facial skin during the test period. 11.Subjects deemed inappropriate to participate in this study by the principle investigator. |
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Target sample size | 50 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Kao Corporation | ||||||
Division name | Biological Science Research | ||||||
Zip code | 321-3497 | ||||||
Address | 2606 Akabane, Ichikai-Machi, Haga-Gun, TOCHIGI, 321-3497, JAPAN | ||||||
TEL | 0285-68-7888 | ||||||
ishikawa.junko1@kao.com |
Public contact | |||||||
Name of contact person |
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Organization | Kao Corporation | ||||||
Division name | Biological Science Research | ||||||
Zip code | 321-3497 | ||||||
Address | 2606 Akabane, Ichikai-Machi, Haga-Gun, TOCHIGI, 321-3497, JAPAN | ||||||
TEL | 0285-68-7888 | ||||||
Homepage URL | |||||||
kawamoto.akane@kao.com |
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 | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | Human Research Ethics Committee, Kao Corporation |
Address | 2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN |
Tel | +81-3-5630-7263 |
morisaki.naoko@kao.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 | 花王株式会社(栃木県) |
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 | No longer recruiting | ||||||
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=R000043928 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |