UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038297 |
|---|---|
| Receipt number | R000043653 |
| Scientific Title | Survey of skin conditions in the delicate areas |
| Date of disclosure of the study information | 2019/10/16 |
| Last modified on | 2020/01/14 16:41:23 |
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Basic information
Public title
Survey of skin conditions in the delicate areas
Acronym
Survey of skin conditions in the delicate areas
Scientific Title
Survey of skin conditions in the delicate areas
Scientific Title:Acronym
Survey of skin conditions in the delicate areas
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of skin condition in the delicate areas by dermatologist
Basic objectives2
Others
Basic objectives -Others
Obtaining knowledge about skin conditions of the delicate area of individuals with incontinence.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Dermatological assessment of the delicate area
Key secondary outcomes
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.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 40 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Female
Key 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.
Key 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
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yuko |
| Middle name | |
| Last name | Fukuda |
Organization
Kao Corporation
Division name
Sanitary Products Research
Zip code
321-3497
Address
2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL
+81-285-68-7561
fukuda.yuko@kao.com
Public contact
Name of contact person
| 1st name | Akemi |
| Middle name | |
| Last name | Yuji |
Organization
Kao Corporation
Division name
Sanitary Products Research
Zip code
321-3497
Address
2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL
+81-285-68-7781
Homepage URL
yuji.aekmi@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
SOUKEN Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Human Research Ethics Committee, Kao Corporation
Address
2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel
+81-3-5630-7263
morisaki.naoko@kao.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
マノメディカルクリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 10 | Month | 16 | 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
111
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 07 | Month | 23 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 23 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 03 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Obtaining knowledge about skin conditions of the delicate area of individuals with incontinence.
Management information
Registered date
| 2019 | Year | 10 | Month | 15 | Day |
Last modified on
| 2020 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043653
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| Registered date | File name |
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