UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008726
Receipt number R000010252
Scientific Title A pilot study to investigarte protective effects of a hydrogel dressing product from excerbation of atopic dermatitis.
Date of disclosure of the study information 2012/08/20
Last modified on 2012/08/20 13:30:08

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Basic information

Public title

A pilot study to investigarte protective effects of a hydrogel dressing product from excerbation of atopic dermatitis.

Acronym

A pilot study to investigarte protective effects of a hydrogel dressing product from excerbation of atopic dermatitis.

Scientific Title

A pilot study to investigarte protective effects of a hydrogel dressing product from excerbation of atopic dermatitis.

Scientific Title:Acronym

A pilot study to investigarte protective effects of a hydrogel dressing product from excerbation of atopic dermatitis.

Region

Japan


Condition

Condition

atopic dermatitis

Classification by specialty

Dermatology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

A pilot study to investigarte protective effects of a hydrogel dressing product from excerbation of atopic dermatitis.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Evaluation of the severity of dermatitis

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

hydrogel dressing product

Interventions/Control_2

LIDOMEX

Interventions/Control_3

HIRUDOID

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

Patients with atopic dermatitis of moderate or more

Key exclusion criteria

Patients with oral steroids or oral cyclosporine
Patients with a history of allergy for Ridomekkusu lotion, ointment, lotion Hirudoido &reg; or hydrogels
Patients suspected of being pregnant or pregnant women
Patients deemed inappropriate by the attending physician

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masutaka Furue

Organization

Kyusyu University Hospital

Division name

Dermatology

Zip code


Address

3-1-1Umadashi, higasi-ku, Fukuoka-city, Fukuoka, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Kyusyu University Hospital

Division name

Dermatology

Zip code


Address

3-1-1Umadashi, higasi-ku, Fukuoka-city, Fukuoka, Japan

TEL


Homepage URL


Email



Sponsor or person

Institute

Kyusyu University Hospital

Institute

Department

Personal name



Funding Source

Organization

ALCARE 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 08 Month 20 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

2011 Year 11 Month 22 Day

Date of IRB


Anticipated trial start date

2012 Year 09 Month 15 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 08 Month 20 Day

Last modified on

2012 Year 08 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010252


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name