UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050595 |
|---|---|
| Receipt number | R000057627 |
| Scientific Title | Stimulation evaluation test for people with sensitive skin of CBN serum |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2023/03/15 15:13:39 |
* 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
Home use test of serum
Acronym
Home use test of serum
Scientific Title
Stimulation evaluation test for people with sensitive skin of CBN serum
Scientific Title:Acronym
Stimulation evaluation test for people with sensitive skin of CBN serum
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of cosmetic ingredients on sensory stimulation.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Skin feelings of stimuli.
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
Prevention
Type of intervention
| Other |
Interventions/Control_1
Stinging test:
Apply aqueous solution A to one cheek and wipe off after 3 minutes. Then apply an aqueous solution B to the opposite cheek and wipe off after 3 minutes. Aqueous solutions C and D and aqueous solutions E and F are applied and wiped in the same manner.
HUT:
Apply Serum A twice a day to all faces> Apply Serum B to all faces twice a day> Apply Serum C to all faces twice a day> Apply Serum D to all faces twice a day, and repeat this procedure three times.
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
| 60 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Healthy female aged 20-60
2. Person who are aware of sensitive skin
3. Person who fall under one or more of the following a or b:
a. Choose and use products that seem to be cosmetics for sensitive skin
b. Have felt irritation with a product used on the face within the last 5 years
4. Person who fall under any two or more of the following A-E:
A. Person who are aware that their facial skin is dry
B. Person who have experienced redness, dryness, or irritation from products used on the face so far
C. Person who feel skin problems during certain seasons or changes of seasons
D. Person who are aware that changes in their physical condition (lack of sleep, fatigue, stress, etc.) are likely to lead to skin problems.
E. Person who are prone to allergic symptoms (seating, sneezing, rhinitis, etc.)
5. Person who use face wash more than 5 days a week
Key exclusion criteria
1. Person who are pregnant, breastfeeding, or may become pregnant in the near future.
2. Person who have an underlying disease.
3. Person who have skin symptoms that may interfere with the ability to accurately judge discomfort such as strong sunburn, wounds, and acne at the test site by visual observation of the test investigator.
4. Person who are currently undergoing outpatient treatment for atopic dermatitis.
5. Person who currently have allergic symptoms (hay fever, allergic rhinitis, etc.).
6. Person who are currently undergoing facial skin treatment.
7. Person who have participated in other exams.
8. Person who have had fever or respiratory symptoms in themselves or a family member living with them during the two weeks before the start date of the measurement, or those who have been in close contact with a person infected with the new coronavirus.
9. Person who plan or wish to be vaccinated against the new coronavirus infection from 2 weeks before the study participation to the end of the study.
10. Person who are wearing pacemakers and implantable spinal cord stimulators.
11. Person who are judged by the principal investigator or the person in charge of conducting the study to be inappropriate.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takafumi |
| Middle name | |
| Last name | Nishijima |
Organization
Kao Corporation
Division name
Safety Scinence Research Lab.
Zip code
250-0002
Address
5-3-28, Kotobukicho, Odawara, Kanagawa, 250-0002, JAPAN
TEL
+81-465-34-8944
nishijima.takafumi@kao.com
Public contact
Name of contact person
| 1st name | Rie |
| Middle name | |
| Last name | Ninomiya |
Organization
Kao Corporation
Division name
Safety Scinence Research Lab.
Zip code
250-0002
Address
5-3-28, Kotobukicho, Odawara, Kanagawa, 250-0002, JAPAN
TEL
+81-465-34-8944
Homepage URL
ninomiya.rie@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
+81-3-5630-9064
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
| 2023 | Year | 04 | 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
60
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 12 | Month | 27 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 27 | Day |
Last follow-up date
| 2023 | Year | 07 | 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
| 2023 | Year | 03 | Month | 15 | Day |
Last modified on
| 2023 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057627
