Healthy adults
Conditions
Interventions
None listed
Sponsors
Kao Corporation
SOUKEN Co., Ltd.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: <Group A: Subjects with incontinence> 1.Be a Japanese woman between 40 and 59 years of age when signing on the consent form 2.Have incontinence every day with about 3 ml of incontinence per time. 3.Have used on a daily basis one or more paper products from the designated products and brands below in the last one month or longer to take care the incontinence; Product list: incontinence pad, incontinence napkin, incontinence liner sanitary napkin, panty-liner <Group B: Subjects without incontinence> 1.Be a Japanese woman between 40 and 59 years of age when signing on the consent form 2.Do not have incontinence <Common inclusion criteria for both groups> 1.Meet either 1A or 1B criteria below 1A. Be 40 to 49 years old (hereinafter described as 40s), have consistent menstrual cycle lasting 26-30 days (+-3 days) with menstrual bleeding lasting for 3 days or more, and have 11 or more periods in the past year. In addition, she needs to receive doctor's examination 10 to 12 days after the period ends. She also has to be a daily (during the menstruation) user of one or more sanitary napkins of the designated brands. 1B:Be a post-menopausal woman between 50 to 59 years of age (hereinafter described as 50s), having no menstruation for more than 12 months since her last period, and within less than five years from menopause. 2.Agree to have skin examination in the delicate area. (There will be a medical examination of the delicate area by a female doctor. During the examination, the doctor may touch the test area.) The delicate area is defined as the pubic area where sanitary napkins contact with when worn. 3.Agreed in writing with their own free will after receiving sufficient explanation and fully understanding of the study.
Exclusion criteria
Exclusion criteria: 1.Systemic diseases(diabetes, heart disease, liver disease, kidney disease, congenital heart disease) 2.Have been infected with hepatitis B virus, hepatitis C virus, human immunodeficiency virus, and syphilis 3.Visit gynecological clinics regularly to take care of menopause-related symptoms or take menopause-related medications 4.Undergoing hormone replacement therapy 5.Take antifungal drugs on a daily basis 6.Topically apply antipruritic and/or antifungal drugs on the delicate area on a daily basis 7.Take antibiotics on a daily basis 8.Use tampons during normal menstrual periods 9.Have skin symptoms other than rash, such as atopic dermatitis or psoriasis in the delicate area 10.Pregnant or lactating or intend to become pregnant during the period of the study 11.Participating in other studies or surveys at the time of recruiting, or who have plans to do so 12.Subjects deemed inappropriate to participate in this study by the principle investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dermatological assessment of the delicate area | — |
Secondary
| Measure | Time frame |
|---|---|
| Understanding of light incontinence and related use of sanitary paper products via questionnaire. Understanding of self-perceived symptoms and awareness of skin troubles in the delicate area via questionnaire. | — |
Countries
Japan
Contacts
Public ContactAkemi Yuji
Kao Corporation Sanitary Products Research
Outcome results
None listed