UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058172 |
|---|---|
| Receipt number | R000066502 |
| Scientific Title | Verification of the effect of the use of the test product on stress -Randomized crossover controlled trial- |
| Date of disclosure of the study information | 2026/03/31 |
| Last modified on | 2026/03/27 14:45:34 |
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Basic information
Public title
Verification of the effect of the use of the test product on stress -Randomized crossover controlled trial-
Acronym
Verification of the effect of the use of the test product on stress
Scientific Title
Verification of the effect of the use of the test product on stress -Randomized crossover controlled trial-
Scientific Title:Acronym
Verification of the effect of the use of the test product on stress
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The study will examine the effect of the test product on stress when used by women who suffer from acne.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in salivary stress markers/indicators due to the use of the test product.
Key secondary outcomes
Changes in psychological stress induced by the test product.
Changes in heart rate and brain waves due to the use of the test product.
Questionnaire regarding skin condition and stress level prior to measurement.
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
Treatment
Type of intervention
| Other |
Interventions/Control_1
Have participants smell the test product for 1 minute
Interventions/Control_2
Apply the test product to their face with their hands for 1 minute
Interventions/Control_3
Have participants wipe with the test product for 1 minute
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 university students aged 18 or older who suffer from acne
2) Non-smokers
3) Not receiving medical treatment for hypertension, diabetes, mental illness, sleep disorders, or serious illnesses
4) Participants who have received an explanation of the study, fully understood the contents, and provided their own informed consent
Key exclusion criteria
1) Heavy alcohol drinkers (average alcohol intake of 60g or more per day)
2) Individuals who have undergone hormone replacement therapy or are taking oral contraceptives within the past year
3) Individuals who are using drugs that affect the secretion of cortisol (steroids, phenytoin, phenobarbital)
4) Individuals with extremely irregular eating habits, or those with irregular lifestyles such as shift workers or night shift workers
5) Individuals taking foods for specified health uses, foods with functional claims, health foods (including supplements), etc. that take into consideration their effects on the autonomic nervous system and sleep
6) Individuals with blocked noses due to hay fever or other conditions that make it difficult to distinguish between different scents
7) Individuals who are allergic to the test products
8) Individuals who prefer fragrance-free products, or those who dislike the scent of the test product.
9) Individuals who are pregnant, wish to become pregnant, or are breastfeeding.
10) Individuals with irregular menstrual cycles (average menstrual cycle of 24 days or less, or 39 days or more).
11) Individuals who are regularly visiting a clinic for acne treatment.
12) Individuals with atopic skin.
13) Individuals who have previously experienced abnormal skin reactions such as redness, swelling, itching, irritation, discoloration (e.g., vitiligo), or hyperpigmentation after using cosmetic products containing ethanol, isopropylmethylphenol, or dipotassium glycyrrhizate.
Target sample size
7
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 | Shuu |
| Middle name | |
| Last name | Imai |
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
Homepage URL
sh.imai@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
Shiba Palace Clinic Ethics Review Committee
Address
6F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo
Tel
03-5408-1599
shiba_palace@s-palace-clinic.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
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
Completed
Date of protocol fixation
| 2025 | Year | 06 | Month | 12 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 12 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 13 | Day |
Last follow-up date
| 2025 | Year | 08 | 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 | 06 | Month | 13 | 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=R000066502
