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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000010009
Receipt No. 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

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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
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 NO
Institution consideration
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
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 30

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
Institute Hokkaido University Graduate School of Medicine, Department of Dermatology
Institute
Department

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
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
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
URL(English) https://upload.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


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