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Confirmation of the safety and functionality of cosmetics containing royal jelly extract on Vulva

Confirmation of the safety and functionality of cosmetics containing royal jelly extract on Vulva - Confirmation of the safety and functionality of cosmetics containing royal jelly extract

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000057372
Enrollment
30
Registered
2025-03-24
Start date
2024-01-10
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Itching and dryness of the pubic area

Interventions

Divided into three groups: using a cleaning agent containing royal jelly extract, a moisturizer, or both. Use for 2 weeks each.

Sponsors

Akita University
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
Changes in vulvar water content, pH, and vulvar symptoms before and after the trial. Usability Questionnaire

Countries

Japan

Contacts

Public ContactHiroshi Miura

Akita University Hospital Department of Obstetrics and Gynecology

miurah@doc.med.akita-u.ac.jp0188846163

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026