UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060683 |
|---|---|
| Receipt number | R000069383 |
| Scientific Title | Questionnaire survey on the usability of intimate care products. |
| Date of disclosure of the study information | 2026/03/01 |
| Last modified on | 2026/02/16 16:44:18 |
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Basic information
Public title
Questionnaire survey on the usability of intimate care products.
Acronym
Questionnaire survey on the usability of intimate care products.
Scientific Title
Questionnaire survey on the usability of intimate care products.
Scientific Title:Acronym
Questionnaire survey on the usability of intimate care products.
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the usability of the test product when applied to the intimate area.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Usability questionnaire
Key secondary outcomes
Intimate care questionnaire
Product concept survey
Adverse events
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Apply the cleanser and moisturizer A to the intimate area for 5 days.
Interventions/Control_2
Apply the cleanser and moisturizer B to the intimate area for 5 days.
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 female adults.
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 who have used or are using intimate care products (specialized cleansers, creams/gels, etc.) within the last 4 weeks.
2. Participants who have a history of allergic reactions from applying cosmetics, or who are at risk of developing allergic reactions.
3. Participants with atopic dermatitis, skin hypersensitivity, or a history of severe contact dermatitis from sanitary napkins.
4. Participants with skin conditions such as trauma or inflammation, or infections (atrophic vaginitis, sexually transmitted infections like vulvar herpes, candidal vulvitis, contact dermatitis (excluding asymptomatic or very mild dermatitis), or other conditions that may affect the evaluation of the vulva) at the test area.
5. Participants who have applied or are applying topical medication to the intimate area within the last 4 weeks.
6. Participants who are pregnant, possibly pregnant, or are breastfeeding.
7. Participants receiving topical hormone replacement therapy (topical medication).
8. Participants who cannot refrain from hair removal or beauty treatments such as esthetics in the test area from the time of obtaining consent until the end of the study.
9. Participants who cannot maintain a regular lifestyle (excluding shift workers).
10. Participants who participated in other clinical trials within the last 4 weeks.
11. Participants who employed by health food, cosmetics, or pharmaceutical companies.
12. Participants who are judged to be inappropriate for participation in this study by the principal investigator.
Target sample size
120
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
| 2026 | Year | 03 | Month | 01 | 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
| 2026 | Year | 02 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 06 | 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
| 2026 | Year | 02 | Month | 16 | Day |
Last modified on
| 2026 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069383
