UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060337 |
|---|---|
| Receipt number | R000069021 |
| Scientific Title | Comparative study on the efficacy of skincare ingredients by skin type |
| Date of disclosure of the study information | 2026/01/13 |
| Last modified on | 2026/01/13 15:27:55 |
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Basic information
Public title
Efficacy study of the skincare product
Acronym
Efficacy study of the skincare product
Scientific Title
Comparative study on the efficacy of skincare ingredients by skin type
Scientific Title:Acronym
Comparative study on the efficacy of skincare ingredients by skin type
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparing the efficacy of skincare products between SSL-RNA clusters.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in skin surface roughness before and after 4 week use of skincare products
Key secondary outcomes
Skin color
Stratum corneum moisture content
TEWL value
Skin surface roughness
Wrinkle score
Melanin index
Hemoglobin index, etc.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
The test product (1) (a commercially available skincare cosmetic) will be applied to the entire face twice daily for four weeks.
Interventions/Control_2
The test product (2) (a commercially available skincare cosmetic) will be applied to the entire face twice daily for four weeks.
Interventions/Control_3
The test product (3) (a commercially available skincare cosmetic) will be applied to the entire face twice daily for four weeks.
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
| 35 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Female
Key inclusion criteria
1.Female participants aged 35 to 59 years.
2.Individuals who have previously experienced discomfort or adverse skin reactions to skincare cosmetics (*) and consequently discontinued their use.
*Examples include skin redness, stinging or tingling sensations, or acne formation.
3.Individuals who are concerned about wrinkles around the outer corners of the
eyes (crow's feet).
4. Individuals who are not currently using any facial serum (beauty essence).
Key exclusion criteria
1.Individuals who have skin conditions such as atopic dermatitis or other dermatological symptoms on the test area (face).
2.Individuals who are pregnant or may be pregnant at the time of obtaining nformed
consent.
3.Individuals who are breastfeeding or plan to breastfeed during the study period.
4.Individuals who are currently visiting a medical institution due to poor hysical
condition or skin disease at the time of recruitment.
5.Individuals who have severe allergies (e.g., hay fever or rhinitis) that may affect the study results.
6.Individuals who regularly take prescription or over-the-counter medications including antibiotics, anti-inflammatory drugs, anti-allergy drugs, sleeping pills, analgesics, hormonal agents, laxatives, or intestinal regulators). Occasional use, about once or twice a month, is acceptable.
7.Individuals who have received cosmetic medical treatments such as peeling or
laser therapy on the face or body within the past six months.
8.Individuals who themselves, or whose family members living in the same
household, are employed in advertising agencies, market research or consulting
firms, mass media, distribution, or in the manufacture of pharmaceuticals,
cosmetics, toiletries, or hygiene products.
9.Individuals who are currently participating, or plan to participate during
this study, in another interventional study (e.g., involving cosmetics or foods)
targeting the facial skin.
10.Individuals who are deemed unsuitable for study participation by the principal investigator for any other reason.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Shou |
| Middle name | |
| Last name | Kikuchi |
Organization
Kao Corporation
Division name
Skin Beauty Products Research Lab.
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-70-3296-8432
kikuchi.shou@kao.com
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Yanagisawa |
Organization
Kao Corporation
Division name
Skin Beauty Products Research Lab.
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-70-3300-8734
Homepage URL
yanaagisawa.hiroki@kao.com
Sponsor or person
Institute
DRC Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
Organization
Division
Category of Funding Organization
Self funding
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
| 2026 | Year | 01 | Month | 13 | 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
120
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
| 2025 | Year | 09 | Month | 17 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 17 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 28 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 01 | Month | 13 | Day |
Last modified on
| 2026 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069021
