UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052297 |
|---|---|
| Receipt number | R000059651 |
| Scientific Title | Exploratory Trial on the Psychological and Physiological Evaluation, as well as the Manifestation of Awareness through Associating Scents with Visual Images, Induced by Smell the scent of the Test Product |
| Date of disclosure of the study information | 2024/09/26 |
| Last modified on | 2024/10/08 11:15:23 |
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Basic information
Public title
Exploratory Trial on the Psychological and Physiological Evaluation, as well as the Manifestation of Awareness through Associating Scents with Visual Images, Induced by Smell the scent of the Test Product
Acronym
Exploratory Trial on the Psychological and Physiological Evaluation, as well as the Manifestation of Awareness through Associating Scents with Visual Images, Induced by Smell the scent of the Test Product
Scientific Title
Exploratory Trial on the Psychological and Physiological Evaluation, as well as the Manifestation of Awareness through Associating Scents with Visual Images, Induced by Smell the scent of the Test Product
Scientific Title:Acronym
Exploratory Trial on the Psychological and Physiological Evaluation, as well as the Manifestation of Awareness through Associating Scents with Visual Images, Induced by Smell the scent of the Test Product
Region
| Japan |
Condition
Condition
Adult female
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the study is to understand the physiological and psychological effects as well as the emotional aspects of human olfactory perception and sensitivity by conducting physiological measurements, psychological assessments, and investigating the words and images associated with the smelled scent.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Autonomic nervous system evaluation (pupil diameter measurement, skin temperature measurement)
Central nervous system evaluation (cerebral blood flow measurement)
Key secondary outcomes
Psychological questionnaire (SCL30, POMS2, VAS)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Smell the aroma by placing your nose close to a container filled with the test product.
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
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
1. Females aged 20 to 49 years old.
2. Subjects who use skincare products containing fragrances.
3. Subjects who have experience with esthetic treatments or similar procedures.
4. Subjects who will be without makeup on the day of the trial or are willing to remove their makeup upon arrival.
5. Subjects who can give informed consent to partake in this research, after being provided with an explanation of the protocol detail.
Key exclusion criteria
1. Subjects who are continuously taking prescription medication as advised by a physician (over-the-counter medication is excluded).
2. Subjects with previous and/or current medical history of serious diseases in heart, liver, kidney and/or digestive organs.
3. Females who are pregnant or lactating, and females who could become pregnant or lactating during test period.
4. Subjects undergoing hormone replacement therapy.
5. Subjects who are experiencing menopausal symptoms (e.g., hot flashes, flushing, sweating).
6. Subjects who are sensitive to cold (including those who are aware of their sensitivity)
7. Subjects with dry eye syndrome.
8. Subjects with eye conditions such as exotropia, esotropia, or ptosis.
9. Subjects currently experiencing nasal congestion due to allergic rhinitis or similar conditions.
10. Subjects who have difficulty perceiving or judging scents.
11. Smokers or Subjects who have quit smoking within the last six months.
12. Subjects with a history or current diagnosis of mental illness.
13. Subjects who regularly consume large amounts of alcohol.
14. Subjects with injuries on their forehead or fingertips (first and second joints).
15. Subjects diagnosed with atopic dermatitis or exhibiting symptoms of skin disorders.
16. Subjects who feel unwell or intoxicated when smelling perfumes or fragrances.
17. Subjects who have been determined ineligible by principal investigator.
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | Ayumi |
| Middle name | |
| Last name | Yamaguchi |
Organization
Mandom Corporation
Division name
Advanced Technology Institute
Zip code
540-0015
Address
5-12, Junikencho, Chuo-ku, Osaka, Japan
TEL
06-7710-1628
ayumi.yamaguchi@mandom.com
Public contact
Name of contact person
| 1st name | Ayumi |
| Middle name | |
| Last name | Yamaguchi |
Organization
Mandom Corporation
Division name
Advanced Technology Institute
Zip code
540-0015
Address
5-12, Junikencho, Chuo-ku, Osaka, Japan
TEL
06-7710-1628
Homepage URL
https://www.mandom.co.jp/
ayumi.yamaguchi@mandom.com
Sponsor or person
Institute
Mandom Corporation
Institute
Department
Personal name
Funding Source
Organization
Mandom Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
Tel
03-6225-9005
IRB@cpcc.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 | 09 | Month | 26 | 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
| 2023 | Year | 09 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 22 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 26 | Day |
Last follow-up date
| 2023 | Year | 10 | 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
| 2023 | Year | 09 | Month | 25 | Day |
Last modified on
| 2024 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059651
