UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039060 |
|---|---|
| Receipt number | R000044545 |
| Scientific Title | Study to elucidate the effect of humidity environment on the rough skin condition. |
| Date of disclosure of the study information | 2020/01/06 |
| Last modified on | 2020/01/06 11:57:28 |
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Basic information
Public title
Study of humidity environment on the rough skin condition.
Acronym
Study of humidity environment on the rough skin condition.
Scientific Title
Study to elucidate the effect of humidity environment on the rough skin condition.
Scientific Title:Acronym
Study of humidity environment on the rough skin condition.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine the influence of humidity on the rough skin feature.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
water content, transepidermal water loss, surface texture, stratum corneum composition and sebum composition
Key secondary outcomes
sweat volume, sweat components, skin surface pH and skin surface temperature
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
We perform acetone ether and water treatment on the inner part of the forearm to create rough skin. Then, we create a few closed environments, then its inside is conditioning humidity for 3 hours.
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
Healthy males and females
Key exclusion criteria
1.Subjects with skin troubles or diseases on their face, especially such as atopic dermatitis, or psoriasis, or severe acne.
2.Subjects who have severe suntan in their faces.
3.Subjects who performs outdoor sport periodically.
4.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.
5.Subjects who have taken a spa treatment (such as chemical peeling, or laser therapy) in the inner forearm region.
6.Subjects who are participating or plan to participate in other intervention tests (cosmetics, foods) in the inner forearm region during the test period.
7.Subjects who have experienced skin abnormalities (obvious erythema, edema, papules, blisters, etc.) by the tape striping and/or acetone ether and water treatment.
8.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 | Junko |
| Middle name | |
| Last name | Ishikawa |
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
| 1st name | Hiroki |
| Middle name | |
| Last name | Taoka |
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
taoka.hiroki@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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 01 | Month | 06 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 31 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 01 | Month | 06 | Day |
Last modified on
| 2020 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044545
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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