UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019425
Receipt number R000022466
Scientific Title Clinical Study of the Acceptability of Sanitary Napkin
Date of disclosure of the study information 2015/12/01
Last modified on 2019/05/09 17:49:23

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Basic information

Public title

Clinical Study of the Acceptability of Sanitary Napkin

Acronym

Clinical Study of the Acceptability of Sanitary Napkin

Scientific Title

Clinical Study of the Acceptability of Sanitary Napkin

Scientific Title:Acronym

Clinical Study of the Acceptability of Sanitary Napkin

Region

Asia(except Japan)


Condition

Condition

Healthy adult females

Classification by specialty

Dermatology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The objective of this study is to evaluate the acceptability of new sanitary napkin in subjects who experienced napkin dermatitis.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

This is an open, prospective study in order to evaluate the skin condition on genital area during the using of sanitary napkin and to evaluate skin's properties measurement (Skin hydration and skin pH)

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Usage test of new sanitary napkin in subjects who experienced napkin dermatitis after the using of their usual sanitary napkin during their last menstrual cycle.

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

20 years-old <=

Age-upper limit

50 years-old >

Gender

Female

Key inclusion criteria

-Healthy females
-Individuals who has experience of any symptoms of the itchiness or the offensive senses under the usage of feminine hygiene products during the last 3 menstrual period before screening.

Key exclusion criteria

-Use of systemic medications or any medicated anti-pruritic or anti-fungal topical products to the genital area within 2 weeks of baseline measurements.
-Individuals with the symptom that is apparently necessary of doctor's care.
-Pregnancy, nursing, or planning to become pregnant during the study as determined by the health questionnaire.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Dr. Danang Agung Yunaidi

Organization

PT Equilab International

Division name

Clinical research

Zip code


Address

JI. RS. Fatmawati Persil 33 Jakarta 12430 Indonesia

TEL

+62-21-7695513

Email

danang@equilab-int.com


Public contact

Name of contact person

1st name
Middle name
Last name Effi Setiawati, Pharm.

Organization

PT Equilab International

Division name

Office

Zip code


Address

JI. RS. Fatmawati Persil 33 Jakarta 12430 Indonesia

TEL

+62-21-7695513

Homepage URL


Email

effi@equilab-int.com


Sponsor or person

Institute

PT Equilab International

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


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

PT Equilab International


Other administrative information

Date of disclosure of the study information

2015 Year 12 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

Completed

Date of protocol fixation

2015 Year 11 Month 30 Day

Date of IRB

2015 Year 11 Month 30 Day

Anticipated trial start date

2015 Year 12 Month 02 Day

Last follow-up date

2016 Year 12 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 10 Month 20 Day

Last modified on

2019 Year 05 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022466


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name