UMIN-CTR Clinical Trial

Public title

Research on women's skin and vulva environment through cohort health study

Acronym

Research on women's skin and vulva environment through cohort health study

Scientific Title

Research on women's skin and vulva environment through cohort health study

Scientific Title:Acronym

Research on women's skin and vulva environment through cohort health study

Region

Japan

Condition

Sexually Transmitted Infections

Classification by specialty

Obstetrics and Gynecology	Dermatology	Adult

Classification by malignancy

Others

Genomic information

YES

Narrative objectives1

The state of vaginal discharge (character, color, amount, odor, etc.) changes depending on a woman's age and sexual cycle, and even if a woman is aware that it is normal, there is a risk of contracting a sexually transmitted disease. Additionally, even if a diagnosis has not been made, the patient may still be at high risk of infection. Therefore, in this study, we will build a system that allows people to self-check their vaginal and vulvar environments by identifying factors associated with the risk of infectious diseases.

Basic objectives2

Others

Basic objectives -Others

The skin flora is said to change depending on lifestyle habits and constitution, and in women in particular, the skin flora is thought to be affected by changes in the component composition of the skin surface due to age and menstrual cycle. Therefore, in this study, we will perform amplicon sequence analysis of female skin flora and compare between research subjects.

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Biological data regarding vaginal discharge and vulva

Key secondary outcomes

Biological data regarding skin

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

20

years-old

<=

Age-upper limit

64

years-old

>=

Gender

Female

Key inclusion criteria

Women who fully understood and provided written consent to participate in the study after receiving an explanation about the study.

Key exclusion criteria

A. Vaginal and vulvar environment study
Those who are in their menstrual period on the day of the test

B. Skin Study
Those currently undergoing skin-related monitoring

Target sample size

250

Name of lead principal investigator

1st name	Ryuuichi
Middle name
Last name	Kiyoe

Organization

KOBAYASHI Pharmaceutical Co., Ltd.

Division name

Household Products Headquarters, Wellness Care Department, Wellness Care R&D Group

Zip code

567-0057

Address

1-30-3, Toyokawa, Ibaraki-shi, Osaka, Japan

TEL

080-3452-9751

Email

r.kiyoe@kobayashi.co.jp

Name of contact person

1st name	Moe
Middle name
Last name	Nishihara

Organization

KOBAYASHI Pharmaceutical Co., Ltd.

Division name

Household Products Headquarters, Wellness Care Department, Wellness Care R&D Group

Zip code

567-0057

Address

1-30-3, Toyokawa, Ibaraki-shi, Osaka, Japan

TEL

080-3009-6436

Homepage URL

Email

m.nishihara@kobayashi.co.jp

Institute

KOBAYASHI Pharmaceutical Co., Ltd.

Institute

Department

Personal name

Organization

KOBAYASHI Pharmaceutical Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Shiba Palace Clinic Ethics Review Committee

Address

DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, Japan

Tel

03-5408-1599

Email

shiba_palace@s-palace-clinic.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

名桜大学

Date of disclosure of the study information

2023

Year

11

Month

23

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

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

Recruitment status

Preinitiation

Date of protocol fixation

2023

Year

09

Month

28

Day

Date of IRB

2023

Year

10

Month

05

Day

Anticipated trial start date

2023

Year

11

Month

23

Day

Last follow-up date

2024

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

1. On the day of the health checkup, we will inform the women who came to the event that we are recruiting subjects for this study through verbal explanations, posters at the venue, and flyers, and those who show interest will be directed to a detailed explanation booth.
2. Explain implementation details and consent to research subjects.
3. We will provide the items necessary for data collection by hand.
4. Live as normal a life as possible without any particular control.
5. Before bathing, collect biological data from the skin of the vulva and vaginal discharge.
6. Collect biological data from skin after you wake up the next morning and before washing your face.
7. Respond to a questionnaire regarding women's health (optional for research subjects who have consented).
8. From the day after the above data collection, research subjects will enclose the kit and questionnaire in the designated return envelope and return it to the designated address.

Registered date

2023

Year

11

Month

13

Day

Last modified on

2023

Year

11

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060231