UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028671
Receipt number R000032825
Scientific Title Study of the effective material on the trouble by napkin
Date of disclosure of the study information 2017/09/01
Last modified on 2017/08/15 16:19:03

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Basic information

Public title

Study of the effective material on the trouble by napkin

Acronym

Study of the trouble by napkin

Scientific Title

Study of the effective material on the trouble by napkin

Scientific Title:Acronym

Study of the trouble by napkin

Region

Japan


Condition

Condition

The trouble by the napkin in the women

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To improve the troublr by the napkin

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Phase I,II


Assessment

Primary outcomes

the status of the skin

Key secondary outcomes

PH


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

putting cosmetic material on the skin

Interventions/Control_2

putting no material on the skin

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

20 years-old <=

Age-upper limit

45 years-old >=

Gender

Female

Key inclusion criteria

the troublr by the napkin

Key exclusion criteria

senstive skin

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuo Sengoku

Organization

Asahikawa Medical University

Division name

Department of OBGY

Zip code


Address

Midorigaokahigashi2-1-1-1, Asahikawa, Hokkaido, Japan

TEL

0166-68-2562

Email

ksen@asahikawa-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Toshinobu Miyamoto

Organization

Asahikawa Medical University

Division name

Department of OBGY

Zip code


Address

Midorigaokahigashi2-1-1-1, Asahikawa, Hokkaido, Japan

TEL

0166-68-2562

Homepage URL


Email

toshim@asahikawa-med.ac.jp


Sponsor or person

Institute

Asahikawa Medical University

Institute

Department

Personal name



Funding Source

Organization

Self Funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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



Other administrative information

Date of disclosure of the study information

2017 Year 09 Month 01 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


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

Preinitiation

Date of protocol fixation

2017 Year 06 Month 01 Day

Date of IRB


Anticipated trial start date

2017 Year 09 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 08 Month 15 Day

Last modified on

2017 Year 08 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032825


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name