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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000031842 |
Receipt No. | R000036362 |
Scientific Title | Effects of environmental changes on the skin. |
Date of disclosure of the study information | 2018/03/22 |
Last modified on | 2019/09/24 |
Basic information | ||
Public title | Effects of environmental changes on the skin. | |
Acronym | Effects of environmental changes on the skin. | |
Scientific Title | Effects of environmental changes on the skin. | |
Scientific Title:Acronym | Effects of environmental changes on the skin. | |
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 | Evaluation effects of environmental changes on the skin properties and its function. |
Basic objectives2 | Others |
Basic objectives -Others | Evaluation effects of environmental changes on the skin properties and its function. |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Evaluate to change and recovery in the forearm skin hydration with TEWL after 24-hour water exposure. |
Key secondary outcomes | Evaluate to change and recovery in the forearm skin hydration with methyl nicotinates permeability, with packing values, with water profiles, the skin surface water content and under the water profiles area under the curve, and with quantification on pools area within cirsta cuites after 24-hour water exposure. |
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 | Prevention | |
Type of intervention |
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Interventions/Control_1 | Water exposure/no treatment for 24 hours to the forearm skin | |
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 | Male and Female | |||
Key inclusion criteria | -20-59 years old healthy adults
-People who have non-troubled on their forearm skin. |
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Key exclusion criteria | -People who have dermatitis (atopic dermatitis etc.).
-People under-medication. -People who have experience of skin troubled with occlusion. -People who is judged as "not eligible" by investigator. For example, those of sunburned, pigmentation, lots of hairs and significant skin contour by his mascule and blood vessel. |
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Target sample size | 10 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Kao Corporation | ||||||
Division name | Biological Science Research | ||||||
Zip code | |||||||
Address | 2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN | ||||||
TEL | +81-285-68-7443 | ||||||
mori.shinobu@kao.com |
Public contact | |||||||
Name of contact person |
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Organization | Kao Corporation | ||||||
Division name | Biological Science Research | ||||||
Zip code | |||||||
Address | 2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN | ||||||
TEL | +81-285-68-7443 | ||||||
Homepage URL | |||||||
fuse.chie@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 | |
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 | 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 | 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=R000036362 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |