UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035367 |
|---|---|
| Receipt number | R000040305 |
| Scientific Title | Study of the effect of occlusion on the skin. |
| Date of disclosure of the study information | 2019/01/07 |
| Last modified on | 2019/11/21 08:44:46 |
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Basic information
Public title
Study of the effect of occlusion on the skin.
Acronym
Study of the effect of occlusion on the skin.
Scientific Title
Study of the effect of occlusion on the skin.
Scientific Title:Acronym
Study of the effect of occlusion on the skin.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of occlusion on the recovery of the damaged stratum corneum(SC).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Daily changes in trans-epidermal water loss value from after the SC damage to recovery.
Key secondary outcomes
Changes in skin surface conditions (structure, color), Changes in the structure of skin blood capillaries, and the skin blood flow.
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
After the SC damage production, put several films with different characteristics on it until damage recovery.
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
Key inclusion criteria
1) Healthy males.
2) Persons who can understand the reason, the method of operation, and the risk of SC damage.
3) Persons who can keep the restrictions during the test period, and follow the investigators' directions.
Key exclusion criteria
1) Persons with skin disease history (e.g. atopic dermatitis, contact dermatitis), or with cutaneous hypersensitivity.
2) Persons whose test sites are not left in both volar forearms for some reason.
3) Persons who participated in the clinical test within one month.
4) Persons deemed inappropriate to participate in this study by the principle investigator.
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Azumi |
| Middle name | |
| Last name | Nagasawa |
Organization
Kao Corporation
Division name
Personal Healthcare Research
Zip code
131-8501
Address
2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
TEL
+81-3-5630-9089
nagasawa.azumi@kao.com
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Taguchi |
Organization
Kao Corporation
Division name
Personal Healthcare Research
Zip code
131-8501
Address
2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
TEL
+81-3-5630-9089
Homepage URL
taguchi.hiroyuki@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
+81-3-5630-9220
uesaka.toshio@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（東京都）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 01 | Month | 07 | 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
12
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
Terminated
Date of protocol fixation
| 2018 | Year | 12 | Month | 26 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 26 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2019 | Year | 05 | Month | 01 | 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 | 12 | Month | 26 | Day |
Last modified on
| 2019 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040305
