UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059455 |
|---|---|
| Receipt number | R000067988 |
| Scientific Title | A Study on the Effects and Perceived Efficacy of Continuous Use of the Test Product in Humans |
| Date of disclosure of the study information | 2026/03/31 |
| Last modified on | 2026/03/27 14:48:45 |
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Basic information
Public title
A Study on the Effects and Perceived Efficacy of Continuous Use of the Test Product in Humans
Acronym
A Study on the Effects and Perceived Efficacy of Continuous Use of the Test Product in Humans
Scientific Title
A Study on the Effects and Perceived Efficacy of Continuous Use of the Test Product in Humans
Scientific Title:Acronym
A Study on the Effects and Perceived Efficacy of Continuous Use of the Test Product in Humans
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of continuous use of test products with different fragrances and application methods on psychological stress and skin condition in women concerned about acne.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in psychological stress indicators during the study period
Key secondary outcomes
Changes in heart rate, estimated hemoglobin value, stress hormones, and sex hormones during the study period
Changes in skin condition during the study period
Changes in the questionnaire on skin condition, skincare habits, sleep, and mood during the study period
Questionnaire on the feeling of use of the test product
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
The investigational product is applied using a cotton wipe.
Interventions/Control_2
The investigational product is applied by patting with the hands.
Interventions/Control_3
The control product is applied using a cotton wipe.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1) Healthy female students aged 18 years or older who are concerned about acne.
2) Non-smokers.
3) Individuals who are not currently undergoing treatment or receiving medical care for hypertension, diabetes, mental illness, sleep disorders, or other serious medical conditions.
4) Individuals who are able to use the investigational product (a wipe-off toner) before their currently used lotion during the study period.
5) Individuals who have provided written informed consent after receiving a full explanation of the study and demonstrating a sufficient understanding of its contents.
Key exclusion criteria
1) Individuals with heavy alcohol consumption (average daily intake of 60g or more).
2) Individuals who have received hormone replacement therapy within the past year or are currently taking oral contraceptives.
3) Individuals using medications that affect cortisol secretion (e.g., steroids, phenytoin, phenobarbital).
4) Individuals with extremely irregular dietary habits or an irregular life rhythm, such as shift workers or night workers.
5) Individuals consuming Foods for Specified Health Uses (FOSHU), Foods with Function Claims, or other health foods (including supplements) that may affect the autonomic nervous system or sleep.
6) Individuals unable to distinguish fragrances due to nasal congestion from hay fever or other reasons.
7) Individuals with an allergy to the test product.
8) Individuals who prefer fragrance-free products or dislike the fragrance of the test product.
9) Individuals who are pregnant, planning to become pregnant, or breastfeeding.
10) Individuals with an irregular menstrual cycle (average cycle length of 24 days or less, or 39 days or more).
11) Individuals continuously receiving medical treatment for acne.
12) Individuals receiving aesthetic treatments, chemical peels, or laser therapy at specialized institutions.
13) Individuals with atopic dermatitis.
14) Individuals who have previously experienced skin abnormalities such as redness, swelling, itching, irritation, color loss (e.g., vitiligo), or darkening after using cosmetics containing ethanol, isopropyl methylphenol, or dipotassium glycyrrhizate.
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Machiko |
| Middle name | |
| Last name | Nishioka |
Organization
KOBAYASHI Pharmaceutical Co., Ltd.
Division name
Life Science Research Department R&D Headquarters
Zip code
567-0057
Address
1-30-3, Toyokawa, Ibaraki-city, Osaka 567-0057 Japan
TEL
072-640-0121
m.nishioka@kobayashi.co.jp
Public contact
Name of contact person
| 1st name | Yukino |
| Middle name | |
| Last name | Koshinaka |
Organization
KOBAYASHI Pharmaceutical Co., Ltd.
Division name
Life Science Research Department R&D Headquarters
Zip code
567-0057
Address
1-30-3, Toyokawa, Ibaraki-city, Osaka 567-0057 Japan
TEL
07055828538
Homepage URL
y.koshinaka@kobayashi.co.jp
Sponsor or person
Institute
KOBAYASHI Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
KOBAYASHI Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Otemon Gakuin Educational Foundation
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Team Care Society Ethics Review Committee
Address
7-4-12 Ginza, Chuo-ku, Tokyo
Tel
03-6274-6421
junko-komatsu@naebafukushikai.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
大阪府
Institutions
Institutions
追手門学院大学 安威キャンパス（大阪府）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 31 | 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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 09 | Month | 03 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 03 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 01 | 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
| 2025 | Year | 10 | Month | 19 | Day |
Last modified on
| 2026 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067988
