Tokyo, March 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060683) titled 'Questionnaire survey on the usability of intimate care products' on March 1.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Active
Primary Sponsor:
Institute - Yamada Bee Company, Inc.
Condition:
Condition - Adult
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the usability of the test product when applied to the intimate area.
Basic objectives2 - Safety,Efficacy
Intervention:
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.
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 Size - 120
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 02 Month 16 Day
Anticipated trial start date - 2026 Year 04 Month 01 Day
Last follow-up date - 2026 Year 06 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069383
Disclaimer: Curated by HT Syndication.
