UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038552 |
|---|---|
| Receipt number | 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 | 2021/01/21 14:39:43 |
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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
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Dermatology | Adult |
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
| Other |
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
| 20 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
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.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Daiki |
| Middle name | |
| Last name | Murase |
Organization
Kao Corporation
Division name
Biological Science Research
Zip code
321-3497
Address
2606 Akabane, Ichikai-Machi, Haga-Gun, TOCHIGI, 321-3497, JAPAN
TEL
0285-68-7231
murase.daiki@kao.com
Public contact
Name of contact person
| 1st name | Naoto |
| Middle name | |
| Last name | Takada |
Organization
Kao Corporation
Division name
Biological Science Research
Zip code
321-3497
Address
2606 Akabane, Ichikai-Machi, Haga-Gun, TOCHIGI, 321-3497, JAPAN
TEL
0285-68-7231
Homepage URL
takada.naoto@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
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
| 2019 | Year | 12 | Month | 01 | 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
50
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
| 2019 | Year | 11 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 29 | Day |
Date of closure to data entry
| 2020 | Year | 10 | Month | 30 | Day |
Date trial data considered complete
| 2020 | Year | 12 | Month | 25 | Day |
Date analysis concluded
| 2020 | Year | 12 | Month | 25 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 11 | Month | 12 | Day |
Last modified on
| 2021 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043928
