UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056309 |
|---|---|
| Receipt number | R000064341 |
| Scientific Title | Efficacy Verification of hypersensitivity suppression ingredients |
| Date of disclosure of the study information | 2024/12/09 |
| Last modified on | 2025/12/04 10:26:55 |
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Basic information
Public title
Lotion Efficacy Verification Test
Acronym
Lotion Efficacy Verification Test
Scientific Title
Efficacy Verification of hypersensitivity suppression ingredients
Scientific Title:Acronym
Efficacy Verification of hypersensitivity suppression ingredients
Region
| Japan |
Condition
Condition
Sensitive skin
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of the effect of continuous use of the test product on suppression of hypersensitivity and improvement of sensitive skin symptoms
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in skin sensitivity before and after 4 weeks of continuous use of the test product
Key secondary outcomes
Improvement of skin condition by subjective and objective evaluation before and after 4 weeks of continuous use of the test product
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Apply each test product twice a day for 4 weeks.
Right side: Test product A
Left side: Test product A control
Interventions/Control_2
Apply each test product twice a day for 4 weeks.
Right side: Test product A control
Left side: Test product A
Interventions/Control_3
Apply each test product twice a day for 4 weeks.
Right side: Test product B
Left side: Test product B control
Interventions/Control_4
Apply each test product twice a day for 4 weeks.
Right side: Test product B control
Left side: Test product B
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
| 49 | years-old | >= |
Gender
Female
Key inclusion criteria
(1) Japanese women in their 20s to 40s
(2) Individuals who have given their free and voluntary consent to participate in the study
(3) Those who feel that they have sensitive skin on their faces.
(4) Residents of Tokyo, Saitama, Chiba, and Kanagawa prefectures.
Key exclusion criteria
(1) Currently undergoing dermatological treatment for a skin disorder
(2) Currently participating or scheduled to participate in a study of skin care products for use on the face.
(3) Who have not yet completed at least 2 weeks after the completion of the study of skin care products for use on the face.
(4) Persons with chronic inflammatory diseases
(5) Those with a current allergic skin disease such as atopic dermatitis
(6) Persons with skin diseases or injuries on the skin of the test site that may affect the test
(7) Persons who have allergic symptoms or peculiar constitution to drugs (including citric acid) or cosmetics.
(8) Have a history of serious skin problems (requiring a visit to a dermatologist) due to the use of cosmetics in the past.
(9) Those who have been exposed to significant sunlight (e.g., went to a tanning salon or went swimming) within the past 4 weeks or are scheduled to do so by the end of the examination.
(10) Those who have undergone facial peeling, laser or other cosmetic medical treatment on the face, cosmetic procedures on the face at esthetic clinics, spas, etc., or art make-up within one month.
(11) Any applicant who has undergone cosmetic medical treatment on the examination site
(12) Those who have undergone any special skin care treatment (beauty salon, esthetic salon, etc.) to the test area within the past 4 weeks.
(13) Those who smoke excessively (more than one pack of cigarettes per day, including e-cigarettes) and have an extremely irregular diet
(14) Those who drink excessively (more than 20g/day of alcohol) for more than 6 days a week.
(15) Pregnant, lactating, or planning to become pregnant by the end of the study
(16) Those who cannot read, write, or communicate in Japanese
(17) Those who work irregular hours on a daily basis, such as night shift work or shift work
(18) Those that did not meet certain criteria at screening
(19) Other subjects deemed unsuitable at the discretion of the principal investigator.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yujiro |
| Middle name | |
| Last name | Endo |
Organization
Lion Corporation
Division name
Beauty Care Research Laboratories
Zip code
132-0035
Address
7-2-1 Hirai, Edogawa-ku, Tokyo, Japan
TEL
080-2268-1602
endo_yu@lion.co.jp
Public contact
Name of contact person
| 1st name | Masayuki |
| Middle name | |
| Last name | Nakagawa |
Organization
Lion Corporation
Division name
Beauty Care Research Laboratories
Zip code
132-0035
Address
7-2-1 Hirai, Edogawa-ku, Tokyo, Japan
TEL
070-1078-7985
Homepage URL
n-masa@lion.co.jp
Sponsor or person
Institute
Lion Corporation
Institute
Department
Personal name
Funding Source
Organization
Lion Corporation
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Macromill, Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Lion Corporation Clinical Review Committee
Address
7-2-1 Hirai, Edogawa-ku, Tokyo, Japan,132-0035
Tel
03-6739-3711
mukkaz@lion.co.jp
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
| 2024 | Year | 12 | Month | 09 | 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
66
Results
This study evaluated a 1% candidate ingredient in a toner used by women with self-reported sensitive skin. Overall, stinging improvement was not statistically confirmed, but a trend toward benefit appeared in the high-sensitivity subgroup. No changes were found in skin physiological parameters or inflammatory cytokines, suggesting possible effects via neuro-related pathways such as TRPV1 or delayed reflection in the stratum corneum.
Results date posted
| 2025 | Year | 12 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Consent Acquisition
Continuous Use of Washout Toner (2 weeks)
Initial Assessment of Skin Condition
Continuous Use of Test Agent (4 weeks)
Assessment of Skin Condition After Continuous Use
Adverse events
The trial was immediately discontinued after confirming five cases of mild skin irritation or peeling. All cases were non-serious and resolved by washing with water or reverting to the skincare products used prior to the trial. The association with the intervention was judged as possible in all cases.
Outcome measures
Skin hypersensitivity
Subjective sensation
Peripheral nerve hypersensitivity
Skin physiological parameters
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 11 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 09 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 11 | Month | 29 | Day |
Last modified on
| 2025 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064341
