UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031842 |
|---|---|
| Receipt number | 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 12:40:22 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Dermatology | Adult |
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
| Other |
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
| 20 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
-20-59 years old healthy adults
-People who have non-troubled on their forearm skin.
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.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinobu Mori |
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
| 1st name | |
| Middle name | |
| Last name | Chie Fuse |
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 or person
Institute
Kao Corporation
Institute
Department
Personal name
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
| 2018 | Year | 03 | Month | 22 | Day |
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
| 2018 | Year | 03 | Month | 07 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 07 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 23 | Day |
Last follow-up date
| 2018 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 22 | Day |
Last modified on
| 2019 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036362
