UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057372 |
|---|---|
| Receipt number | R000062306 |
| Scientific Title | Confirmation of the safety and functionality of cosmetics containing royal jelly extract on Vulva |
| Date of disclosure of the study information | 2025/03/24 |
| Last modified on | 2025/03/24 11:54:06 |
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Basic information
Public title
Confirmation of the safety and functionality of cosmetics containing royal jelly extract on Vulva
Acronym
Confirmation of the safety and functionality of cosmetics containing royal jelly extract
Scientific Title
Confirmation of the safety and functionality of cosmetics containing royal jelly extract on Vulva
Scientific Title:Acronym
Confirmation of the safety and functionality of cosmetics containing royal jelly extract
Region
| Japan |
Condition
Condition
Itching and dryness of the pubic area
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of the safety of products containing royal jelly extract when used on the vulva and their functionality on the skin.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
After using a cleaning agent and moisturizer containing royal jelly extract for 2 weeks, the skin irritation is evaluated by a specialist and the subject's subjectivity.
Key secondary outcomes
Changes in vulvar water content, pH, and vulvar symptoms before and after the trial. Usability Questionnaire
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Divided into three groups: using a cleaning agent containing royal jelly extract, a moisturizer, or both. Use for 2 weeks each.
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Female
Key inclusion criteria
Applicants must meet all of the following criteria:
1) Able-bodied women living in Japan who are 18 years of age or older at the time of obtaining consent
2) Those who can understand and comply with management matters during the period of this research
3) Those who have fully understood the content of this study and obtained written consent of the subject of their own free will in order to participate in this study.
4) A person who has been recognized as eligible by the principal investigator, etc. in a comprehensive judgment
Key exclusion criteria
Patients with any of the following will not be included in this study:
1) Those who have used or are using vulva care products (special cleaning agents, special creams/gels, etc.) within the last 4 weeks
2) Those who have had allergic symptoms due to the application of cosmetics, those who are likely to have allergic symptoms, or those who have a weak positive (or more) in a patch test performed in advance.
3) Those who have atopic dermatitis, skin sensitivity, or severe rash caused by napkins
4) Those who have skin symptoms such as trauma or inflammation or infections (sexually transmitted diseases such as atrophic vaginitis and vulvar herpes, candidal vulvitis, contact dermatitis (excluding asymptomatic and very minor dermatitis), and other diseases that affect the evaluation of the vulva) at the measurement site (pubic area).
5) A person who has an abnormality in the vulva in the questionnaire and medical examination
6) Those who have applied or are applying the drug to the vulva within the last 4 weeks
7) Those who are pregnant or may be pregnant and those who are breastfeeding
8) Those who are receiving hormone replacement therapy (estrogen preparations (oral medicines, patches, ointments, etc.))
9) Those who cannot prohibit cosmetic care such as hair removal and esthetics in the test area from the time of obtaining consent until the end of the study.
10) Those who are unable to maintain a regular life (excluding those who work in shifts)
11) Those who have participated in other human studies (including food consumption tests) within the last 4 weeks
12) Those who work for health food companies, cosmetics companies, or pharmaceutical companies
13) Other persons who have been judged by the principal investigator to be inappropriate for participation in this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Miura |
Organization
Akita University Hospital
Division name
Department of Obstetrics and Gynecology
Zip code
010-8543
Address
Akita, Akita, Hiro-omote, Hasunuma 44-2
TEL
0188846163
miurah@doc.med.akita-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Miura |
Organization
Akita University Hospital
Division name
Department of Obstetrics and Gynecology
Zip code
010-8543
Address
Akita, Akita, Hiro-omote, Hasunuma 44-2
TEL
0188846163
Homepage URL
miurah@doc.med.akita-u.ac.jp
Sponsor or person
Institute
Akita University
Institute
Department
Personal name
Funding Source
Organization
Yamada Bee Farm
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
Ethics Committee of Akita University Graduate School of Medicine
Address
Akita, Akita, Hiro-omote, Hasunuma 44-2
Tel
0188341111
nintei@hos.akita-u.ac.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
| 2025 | Year | 03 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
30
Results
Main Evaluation Items
Evaluation by Physicians
<Clinical Symptom Assessment> (Before and After Use)
No clinical symptoms in all 25 participants (all scored 0). Five participants exhibited very mild skin dryness rated at "slight (0.5 points)."
<Comprehensive Tolerability Assessment> (Post-Use)
In 28 cases, the assessment was "1 Very Good." Only 2 cases were rated as "2 Good."
<Overall Summary Evaluation> (Post-Use)
Based on the above, most subjects showed very good tolerability.
Results date posted
| 2025 | Year | 03 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Healthy women aged 18 and over
[Selection Criteria]
1) Healthy women residing in Japan who are 18 years of age or older at the time of consent.
2) Those who can understand and comply with management matters during the study period.
3) Those who have obtained written consent based on their own free will after fully understanding the content of their participation in this study.
4) Those deemed eligible by the principal investigator based on comprehensive judgment.
Participant flow
1. RJ extract-containing cleansing agent
2. RJ extract-containing gel
3. Combination of 1 and 2
1. Use once a day during bathing. Dispense 3 pumps into your hand, gently apply to the delicate area, and rinse well with water.
2. Use once a day after bathing. After drying with a towel, dispense a length from the fingertip to the first joint (approximately 2.5 cm, about 0.4 g), and gently apply to the delicate area.
3. Use 1 during bathing, and then use 2 after bathing.
Adverse events
No adverse event
Outcome measures
1) Main evaluation items
Assessment of skin irritation by a specialist and the presence or absence of skin irritation based on the subject's subjective opinion.
[Doctor's Assessment] <Clinical Symptoms Evaluation> (Before and After Use)
Skin dryness, erythema, edema, desquamation, itching (asked verbally to the subject), scratching (visual assessment), burning sensation (asked verbally to the subject), tingling (asked verbally to the subject), and other clinical signs of irritation in the genital area. 0 = "none", 0.5 = "very mild", 1 = "mild", 2 = "moderate", 3 = "severe" on a 5-point scale.
<Comprehensive Evaluation of Tolerance> (After Use) *Assessment for each subject
Rated on a 5-point scale 1 = "very good", 2 = "good", 3 = "acceptable", 4 = "bad", 5 = "very bad"
<Overall Summary Evaluation> (After Use) *Evaluation for the entire trial.
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
| 2024 | Year | 01 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2025 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 03 | Month | 24 | Day |
Last modified on
| 2025 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062306
