UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053008 |
|---|---|
| Receipt number | R000060402 |
| Scientific Title | Actual research on skin flora and skin condition, and effectiveness test of developed moisturizing cream |
| Date of disclosure of the study information | 2023/12/14 |
| Last modified on | 2023/11/29 09:40:02 |
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Basic information
Public title
Research on skin flora and skin conditions and efficacy test of moisturizer
Acronym
Research on skin flora and skin conditions and efficacy test of moisturizer
Scientific Title
Actual research on skin flora and skin condition, and effectiveness test of developed moisturizing cream
Scientific Title:Acronym
Research on skin flora and skin conditions and efficacy test of moisturizer
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To preliminarily examine the effectiveness of the developed moisturizing cream in improving redness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Cheek redness improvement effect before and after using the developed moisturizing cream for 2 and 4 weeks
Key secondary outcomes
-TEWL value
- Stratum corneum moisture content value
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
Central registration
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Apply the developed moisturizing cream to half the face twice a day for 4 weeks.
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
| 40 | years-old | >= |
Gender
Female
Key inclusion criteria
1.Japanese women between 20 and 40 years old at the time of obtaining consent
2.Those who select score 3 or score 4 from the 4-level redness scale for their cheeks
3.Those who select "I feel a lot" or "I feel it" about the amount of sebum, oiliness, and shine on their own facial skin.
4.Those who regularly use lotions and emulsions 5 days or more a week
Key exclusion criteria
1.Those who are pregnant or may be pregnant, breastfeeding, or less than 6 months postpartum
2.Those who have participated in other studies (all studies using cosmetics, food, pharmaceuticals, quasi-drugs, medical devices, etc.) within the past 4 weeks, or those who have participated in other human studies during the scheduled implementation period of this study. Those who are planning to participate.
3.Those with skin symptoms such as atopic dermatitis or contact dermatitis.
4.Those with a history of allergies or rashes to cosmetics, adhesive tapes, medical tapes, etc.
5.Those with facial skin abnormalities (rash, eczema, wounds,bruises, etc.).
6.Those who have had severe sunburn on their face within the past month
7.Those who are visiting a medical institution due to poor physical condition or skin disease.
8.Those using cosmetics, quasi-drugs, or pharmaceuticals that may affect the test (peels, steroids, anti-inflammatory drugs, topical drugs, antibacterial drugs,etc.).
9.Those with seasonal allergies such as severe hay fever.
10.Those who have received cosmetic treatment for the face (laser treatment, collagen injection, etc.).
11.Those who have had aesthetic treatment on their face within the past month
12.Those who use home facial beauty devices or beauty equipment
13.Those who have a habit of smoking.
14.Persons involved in this study (employed by the test sponsor or the test contract organization)
15.Those who are engaged in a related industry (the person or a family member is in a related industry such as the pharmaceutical industry, cosmetics industry, advertising magazine, etc.)
16.Those who are deemed unsuitable for research participation by the research director due to violation of compliance obligations,etc.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Kaori |
| Middle name | |
| Last name | Tojo |
Organization
Kao Corporation
Division name
Skin Care Research Lab.
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-3-5630-7286
tojo.kaori@kao.com
Public contact
Name of contact person
| 1st name | Masafumi |
| Middle name | |
| Last name | Takata |
Organization
Kao Corporation
Division name
Skin Care Research Lab.
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-3-5630-7286
Homepage URL
takata.masafumi@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
Market Development Research company
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 | 12 | Month | 14 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 11 | Month | 14 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 14 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 14 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 11 | 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 | 12 | Month | 05 | Day |
Last modified on
| 2023 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060402
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
