UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006922
Receipt number R000008169
Scientific Title Application test of a skin care medicine (cleansing agent) in patients with skin diseases such as atopic dermatitis and asteatotic dermatitis.
Date of disclosure of the study information 2011/12/23
Last modified on 2019/03/31 09:38:30

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Basic information

Public title

Application test of a skin care medicine (cleansing agent) in patients with skin diseases such as atopic dermatitis and asteatotic dermatitis.

Acronym

Application test of a skin care medicine (cleansing agent) in patients with skin diseases such as atopic dermatitis and asteatotic dermatitis.

Scientific Title

Application test of a skin care medicine (cleansing agent) in patients with skin diseases such as atopic dermatitis and asteatotic dermatitis.

Scientific Title:Acronym

Application test of a skin care medicine (cleansing agent) in patients with skin diseases such as atopic dermatitis and asteatotic dermatitis.

Region

Japan


Condition

Condition

The test participants are patients with a condition, such as atopic dermatitis or asteatotic dermatitis, who presented with symptoms of inflammation and xerosis.

Classification by specialty

Dermatology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To offer a cleansing agent that can be used at ease as a skin care medicine in daily life and the appropriate directions for the patient with dermatosis with skin dryness and an inflammation such as atopic dermatitis and asteatotic dermatitis.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

The severity of symptoms (erythema, papule, desquamation, xerosis, etc.) of the subject must not worsen, and the morphology and area of the stratum corneum (indicates the degree of cornification of the epidermal cells)

Key secondary outcomes

Skin measurements were performed by using measuring devices and analyzing the horny cell layer by using tape-stripping method.
Moisture content of the epidermal horny cell layer, amount of moisture loss through the skin, cytokines in the horny cell layer


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

Behavior,custom

Interventions/Control_1

After 4 weeks of conditioning, for normal personal use, substitute the cleansing agent with the product of this study.

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1.Progression of the underlying disease was slow; therefore, the attending physician considered the product to be useful in maintaining and improving skin condition.
2.Patient who can be medically examined at 4 and 8 weeks (a deviation of 1 week before or after is allowed) after the start of the study
3.Patient from whom written consent (consent from a legal guardian in case of minors) can be obtained. Further information about age and sex need not be asked.

Key exclusion criteria

1.irritation or an allergic skin reaction because of the use of the product.
2.Patients with severe skin rashes such as contagious impetigo or Kaposi varicelliform eruption in the area where the product was used
3.Patients who cannot be medically examined at 4 and 8 weeks (as a general rule) after the start of the study
4.Patient whose participation in the study is deemed inappropriate by the attending physician

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Furue
Middle name
Last name Masutaka

Organization

Kyusyu University

Division name

Department of Dermatology, Graduate School of Medical Sciences

Zip code

812-0054

Address

3-1-1 Maidashi Higashi-ku Fukuoka 812-8582 JAPAN

TEL

092-642-5596

Email

takeuchs@dermatol.med.kyushu-u.ac.jp


Public contact

Name of contact person

1st name Satoshi
Middle name
Last name Takeuchi

Organization

Kyusyu University Hospital

Division name

Dermatology

Zip code

812-0054

Address

3-1-1 Maidashi Higashi-ku Fukuoka 812-8582 JAPAN

TEL

092-642-5596

Homepage URL

http://www.kyudai-derm.org/part/treat/recent.html

Email

takeuchs@dermatol.med.kyushu-u.ac.jp


Sponsor or person

Institute

Kyusyu University Hospital

Institute

Department

Personal name



Funding Source

Organization

Tokiwa Pharmaceutical Co.,Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

JAPAN


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kyusyu University Hospital Certified Review Board

Address

3-1-1 Maidashi Higashi-ku Fukuoka 812-8582 JAPAN

Tel

092-642-5774

Email

bynintei@jimu.kyushu-u.ac.jp


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

九州大学病院(福岡県)


Other administrative information

Date of disclosure of the study information

2011 Year 12 Month 23 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

20

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

2011 Year 10 Month 19 Day

Date of IRB

2011 Year 08 Month 01 Day

Anticipated trial start date

2011 Year 12 Month 01 Day

Last follow-up date

2019 Year 03 Month 01 Day

Date of closure to data entry

2019 Year 03 Month 31 Day

Date trial data considered complete

2019 Year 03 Month 31 Day

Date analysis concluded

2019 Year 09 Month 30 Day


Other

Other related information



Management information

Registered date

2011 Year 12 Month 21 Day

Last modified on

2019 Year 03 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008169


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name