UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009381
Receipt number R000011026
Scientific Title The use testing of moisturizing bath additive (quasi-drugs) for dry skin
Date of disclosure of the study information 2012/12/01
Last modified on 2014/11/23 09:53:50

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Basic information

Public title

The use testing of moisturizing bath additive (quasi-drugs) for dry skin

Acronym

The use testing of moisturizing bath additive

Scientific Title

The use testing of moisturizing bath additive (quasi-drugs) for dry skin

Scientific Title:Acronym

The use testing of moisturizing bath additive

Region

Japan


Condition

Condition

atopic dermatitis, psoriasis vulgalis

Classification by specialty

Dermatology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Verify that the rate of side effects is less than 5%, when patients presenting dry skin use moisturizing bath additives.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

After using moisturizing bath additive for 8 weeks, collect the stratum corneum.

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

Prevention

Type of intervention

Other

Interventions/Control_1

Use moisturizing bath additive for 8 weeks

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

It is determined that this product is ueful for treat a patient.
The name of the disease does not matter, if the disease has symptoms of dry skin.
Do not limit the treatment of the underlying disease.
A person 20 years of age or older
Gender does not matter
Those who written informed consent is obtained from

Key exclusion criteria

Those who have experience gave rise to skin conditions such as contact dermatitis due to ingredients and similar components of this study
A person who has improper skin eruption in the application site of this product.
Those who can not (in principle) be examined after 8 weeks
A person under 20
Those who can not judge a person by themselves, such as dementia
An pregnancy and lactation
Those who are deemed inappropriate to participate in this study by doctor.

Target sample size

70


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshiki Miyachi

Organization

Graduate School of Medicine, Kyoto University

Division name

Department of Dermatology

Zip code


Address

54 Shogoinkawahara-cho, Sakyo-ku,Kyoto, 6068507, Japan

TEL

075-751-3310

Email

hifuka@kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Akihiro Fujisawa

Organization

Graduate School of Medicine, Kyoto University

Division name

Department of Dermatology

Zip code


Address

54 Shogoinkawahara-cho, Sakyo-ku,Kyoto, 6068507, Japan

TEL

075-751-3310

Homepage URL


Email

fujiaki@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Department of Dermatology, Graduate School of Medicine, Kyoto University

Institute

Department

Personal name



Funding Source

Organization

TOKIWA Pharmaceutical Co.,Ltd.

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

2012 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

2012 Year 11 Month 10 Day

Date of IRB


Anticipated trial start date

2012 Year 12 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

2012 Year 11 Month 21 Day

Last modified on

2014 Year 11 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011026


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name