UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059029 |
|---|---|
| Receipt number | R000067482 |
| Scientific Title | A study on the safety and user experience of continuous use of warming cosmetic products. |
| Date of disclosure of the study information | 2025/09/12 |
| Last modified on | 2025/09/08 14:05:06 |
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Basic information
Public title
A study on the safety and user experience of continuous use of warming cosmetic products.
Acronym
A study on the safety and user experience of continuous use of warming cosmetic products.
Scientific Title
A study on the safety and user experience of continuous use of warming cosmetic products.
Scientific Title:Acronym
A study on the safety and user experience of continuous use of warming cosmetic products.
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the safety and user experience of the test product after application to the body.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adverse events
Key secondary outcomes
User experience questionnaire
Perceived efficacy questionnaire
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Apply the test product (warming cosmetics) to the specified body parts for 4 weeks.
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
| Not applicable |
Gender
Female
Key inclusion criteria
1) Healthy Japanese adult women.
2) Participants who understand and can comply with the rules and guidelines throughout the study period.
3) Participants who have provided written informed consent of their own free will after fully understanding the study details.
Key exclusion criteria
1. Participants with pain due to gout or rheumatism.
2. Participants with neuropathic or traumatic shoulder, knee, or elbow pain.
3. Participants who have undergone or are currently in need of surgery on their shoulder, lower back, or knee.
4. Participants who regularly use cosmetics or quasi-drugs for body care.
5. Participants who are continuously using pharmaceuticals or quasi-drugs on the test area.
6. Participants who are currently receiving, or planning to receive, treatment from a medical institution for the treatment or prevention of a disease on the test area during the study period (e.g., drug therapy, exercise therapy, diet therapy, acupuncture, massage, physical therapy, and other treatments).
7. Participants with a history of alcohol or drug dependence.
8. Participants who have previously experienced allergic symptoms, such as itching, from cosmetics.
9. Participants who have previously experienced skin problems from warming/cooling products (cosmetics, quasi-drugs, or pharmaceuticals).
10. Participants who are pregnant, breastfeeding, or planning to become pregnant during the study period.
11. Participants who have participated in another clinical study (e.g., using cosmetics, foods, drugs, quasi-drugs, or medical devices) within the last 4 weeks prior to informed consent, or who plan to participate in another clinical study during the scheduled period of this study.
12. Participants who are judged to be inappropriate for participation in this study by the principal investigator.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takato |
| Middle name | |
| Last name | Nikaido |
Organization
Yamada Bee Company, Inc.
Division name
Yamada Bee Company group Institute for Beauty Science, R&D department
Zip code
708-0393
Address
194 Ichiba, Kagamino-cho, Tomata-gun, Okayama 708-0393 Japan
TEL
0868-54-3825
tn2381@yamada-bee.com
Public contact
Name of contact person
| 1st name | Chizuru |
| Middle name | |
| Last name | Fujikura |
Organization
Yamada Bee Company, Inc.
Division name
Yamada Bee Company group Institute for Beauty Science, R&D department
Zip code
708-0393
Address
194 Ichiba, Kagamino-cho, Tomata-gun, Okayama 708-0393 Japan
TEL
03-6424-8434
Homepage URL
ch1644@yamada-bee.com
Sponsor or person
Institute
Yamada Bee Company, Inc.
Institute
Department
Personal name
Funding Source
Organization
Yamada Bee Company, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Research Center for Immunological Analysis, Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yamada Bee Company Ethics Committee
Address
194 Ichiba, Kagamino-cho, Tomata-gun, Okayama
Tel
0868-54-1199
irb@yamada-bee.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
| 2025 | Year | 09 | Month | 12 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 09 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 30 | 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 | 09 | Month | 08 | Day |
Last modified on
| 2025 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067482
