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