UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000010009
Receipt number	R000008836
Scientific Title	Study to evaluate the efficacy of conventional topical therapy for atopic dermatitis based on Filaggrin-gene mutations
Date of disclosure of the study information	2013/02/12
Last modified on	2013/02/11 15:55:29

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Basic information

Public title

Study to evaluate the efficacy of conventional topical therapy for atopic dermatitis based on Filaggrin-gene mutations

Acronym

Study to evaluate the efficacy of conventional topical therapy for atopic dermatitis based on Filaggrin-gene mutations

Scientific Title

Study to evaluate the efficacy of conventional topical therapy for atopic dermatitis based on Filaggrin-gene mutations

Scientific Title:Acronym

Study to evaluate the efficacy of conventional topical therapy for atopic dermatitis based on Filaggrin-gene mutations

Region

Japan

Condition

Atopic dermatitis

Classification by specialty

Dermatology

Classification by malignancy

Others

Genomic information

YES

Objectives

Narrative objectives1

To evaluate the difference in the efficacy of moisturizer, steroid and tacrolimus ointment for atopic dermatitis based on the presence and absence of filaggrin gene mutations.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

Amount of change in the score of intensity which is used in SCORAD.
6 criteria include erythema, edema/ papulation, oozing/ crusting, excoriation and lichenification which is scored by 0 to 3 points respectively.

Key secondary outcomes

TEWL
SC hydration
VAS of itch
Evaluation of presence or absence of flare-ups in the sites which are/ are not apllied moisturizer for the sites without eruption.

Base

Study type

Interventional

Study design

Basic design

Factorial

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

No treatment

Stratification

YES

Dynamic allocation

Institution consideration

Blocking

Concealment

Central registration

Intervention

No. of arms

Purpose of intervention

Treatment

Type of intervention

Medicine Gene

Interventions/Control_1

Applying Split-plot design, multiple factors are randomized. 4 sites of each cubital fossa and popliteal fossa are used as a independent site respectively.
1st factor is presence or absence of filaggringene mutation.

Interventions/Control_2

2nd factor for allotment is combination of the usage or non-usage of moisturizer and treatment. Treatment includes steroid ointment and tacrolimus ointment.

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

2 years-old <=

Age-upper limit

15 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients of atopic dermatitis diagnosed by the diagnostic criteria for atopic dermatitis by Hanifin & Rajika, U.K.Working Party or Japan Society of Dermatology.
Patients with moderate to severe skin lesions.

Key exclusion criteria

Patients who have obviously infected lesion in the popliteal and cubital fossa.
Patients who have atrophy or telangiectasia in the popliteal and cubital skin caused by the topical steroid application.
Patients who has serious underlying disease.
Patients who had participated in other clinical trials within 6 months.

Target sample size

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name Hiroshi Shimizu

Organization

Hokkaido University Hospital

Division name

Department of Dermatology

Zip code

Address

Kita 14 Nishi 5, Kita-Ku, Sapporo, Hokkaido, Japan

TEL

011-706-7387

Email

Public contact

Name of contact person

1st name

Middle name

Last name Osamu Mizuno

Organization

Hokkaido University Hospital

Division name

Department of Dermatology

Zip code

Address

Kita 14 Nishi 5, Kita-Ku, Sapporo, Hokkaido, Japan

TEL

011-706-7387

Homepage URL

Email

Sponsor or person

Institute

Hokkaido University Graduate School of Medicine, Department of Dermatology

Institute

Department

Personal name

Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

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

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

北海道大学病院（北海道）

Other administrative information

Date of disclosure of the study information

2013 Year 02 Month 12 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

Open public recruiting

Date of protocol fixation

2012 Year 02 Month 22 Day

Date of IRB

Anticipated trial start date

2012 Year 04 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

2013 Year 02 Month 11 Day

Last modified on

2013 Year 02 Month 11 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008836

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name