UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042177 |
|---|---|
| Receipt number | R000048138 |
| Scientific Title | Confirmation of suppression effect of UV erythema by dressing material |
| Date of disclosure of the study information | 2020/10/20 |
| Last modified on | 2020/10/22 10:40:37 |
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Basic information
Public title
Evaluation of dressing material
Acronym
Evaluation of dressing material
Scientific Title
Confirmation of suppression effect of UV erythema by dressing material
Scientific Title:Acronym
Evaluation of dressing material
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To Confirm the suppression effect of UV erythema by dressing material
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in skin color
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
After inducing ultraviolet erythema on the inside of the upper arm, the dressing materials are used for one week.
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
1.Healty adults, aged 20-59
2.Persons who understand the contents and the schedule of the test and can follow the test instructions.
Key exclusion criteria
1.Persons who have the history of atopic dermatitis, contact dermatitis, or have sensitive skin.
2. Persons who have the history of photodermatosis.
3. Persons who have some wound or damages at test site.
4. Persons who have excessive sunburns at test site.
5. Persons who regularly do outdoor activities with sunburns.
6. Persons who use medicines or cosmetics at test site.
7. Persons who take any medicine regularly.
8. Persons deemed inappropriate to participate in this test by the principle investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kouichi |
| Middle name | |
| Last name | Misawa |
Organization
Kao Corporation
Division name
Biological Science Research
Zip code
131-8501
Address
2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
TEL
+81-3-5630-7268
misawa.koichi@kao.com
Public contact
Name of contact person
| 1st name | Yoshie |
| Middle name | |
| Last name | Shimotoyodome |
Organization
Kao Corporation
Division name
Biological Science Research
Zip code
131-8501
Address
2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
TEL
+81-3-5630-7266
Homepage URL
shimotoyodome.yoshie@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
Yaesu Nihonbashi Skin Clinic
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
| 2020 | Year | 10 | Month | 20 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 10 | Month | 14 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 14 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2020 | Year | 12 | 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 | 10 | Month | 20 | Day |
Last modified on
| 2020 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048138
