UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019993
Receipt number R000023078
Scientific Title Usefulness of the barrier-free underwear for the dry skin
Date of disclosure of the study information 2015/11/30
Last modified on 2016/07/05 11:59:04

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Usefulness of the barrier-free underwear for the dry skin

Acronym

Efficacy of the barrier-free underwear

Scientific Title

Usefulness of the barrier-free underwear for the dry skin

Scientific Title:Acronym

Efficacy of the barrier-free underwear

Region

Japan


Condition

Condition

asteatotic dermatitis, atopic dermatitis, pruritus, psoriasis vulgaris, lichen planus

Classification by specialty

Dermatology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study is to wear the underwear without sewing for four weeks in a skin disease to be worsened by a dry skin disease and friction and stimulation. By analyzing QOL and the skin lesion before and after the wearing, we investigate the efficacy of skin barrier in the underwear.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

We analyze the severity of the skin lesion severity (erythema, nodule, drying, lichenification) from underwear wearing on day 0, day 14, and day 28.

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

duration of intervention :28 days. Wearing the underwear every day.

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


Not applicable

Gender

Male and Female

Key inclusion criteria

* The patients of skin diseases with a dry lesion
* Man and woman with the ability for judgment 20 years or older
* The patient who has an itch, a pain before wearing the underwear
* The patient diagnosed skin lesion such as drying, erythema, nodule, or lichenification before wearing the underwear

Key exclusion criteria

* The patients taken the oral administration of immunosuppressive drugs such as steroid , cyclosporine tacrolimus and injection of the biological preparation
* The patients with the injury
* The patients during Pregnancy or lactation
* The patients of alcoholism
* The patients who is connected with this study

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ichiro Katayama

Organization

Osaka University Graduate School of Medicine

Division name

Department of Dermatology

Zip code


Address

2-2 yamadaoka Suita city, Osaka

TEL

06-68779-3031

Email

katayama@derma.med.osaka-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Saori ochi

Organization

Osaka University Graduate School of Medicine

Division name

Department of Dermatology

Zip code


Address

2-2 yamadaoka Suita city, Osaka

TEL

06-6879-3031

Homepage URL


Email

102itoi@derma.med.osaka-u.ac.jp


Sponsor or person

Institute

Department of Dermatology, Osaka University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Gunze Company

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



Other administrative information

Date of disclosure of the study information

2015 Year 11 Month 30 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


Anticipated trial start date

2015 Year 12 Month 07 Day

Last follow-up date


Date of closure to data entry

2016 Year 07 Month 05 Day

Date trial data considered complete


Date analysis concluded

2016 Year 07 Month 05 Day


Other

Other related information



Management information

Registered date

2015 Year 11 Month 30 Day

Last modified on

2016 Year 07 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023078


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name