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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000018787
Receipt No. R000020416
Scientific Title Examination of the effect of hyposensitization therapy by sweat and Malassezia antigen
Date of disclosure of the study information 2015/09/01
Last modified on 2018/05/30

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Basic information
Public title Examination of the effect of hyposensitization therapy by sweat and Malassezia antigen
Acronym Hyposensitization therapy by sweat and Malassezia antigen
Scientific Title Examination of the effect of hyposensitization therapy by sweat and Malassezia antigen
Scientific Title:Acronym Hyposensitization therapy by sweat and Malassezia antigen
Region
Japan

Condition
Condition Atopic dermatitis and cholinergic urticaria
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Examination of the effect of hyposensitization therapy by sweat and Malassezia antigen in patients with cholinergic urticaria and atopic dermatitis.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Improvement of ich and skin symptoms on heating load test
Key secondary outcomes

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
Other
Interventions/Control_1 hyposensitization therapy by sweat antigen or Malassezia antigen
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
12 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria 1. Patients with atopic dermatitis or cholinergic urticaria
2. No change of treatment within one month.
3. Patients who can visit our clinic reguraly.
4. Patients who are 12 years old or more and 80 years or less.
5. Patients who can sign a contract.
6. Patients who have allergy to sweat antigen or Malassezia antigen.
Key exclusion criteria 1. Patients who have unstable symptoms.
2. Patients who have history of strong allergy against food or dust or etc.
3. Patients who are pregnant or have possibility of pregnancy.
4. Patients with severe primary disease like severe arteriosclerosis, severe hypertension and heart failure.
5. Patients who are seemed to impertinent by a responsible person.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Michihiro Hide
Organization Hiroshima University Hospital
Division name Dermatology
Zip code
Address 1-2-3, Kasumi, Minami-ku, Hiroshima
TEL 082-257-5237
Email ed1h-w1de-road@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shunsuke Takahagi
Organization Hiroshima University Hospital
Division name Dermatology
Zip code
Address 1-2-3, Kasumi, Minami-ku, Hiroshima
TEL 082-257-5237
Homepage URL
Email takshuns@gmail.com

Sponsor
Institute Hiroshima Umiversity Hospital
Institute
Department

Funding Source
Organization Hiroshima University Hospital
Organization
Division
Category of Funding Organization Other
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
2015 Year 09 Month 01 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 Terminated
Date of protocol fixation
2015 Year 08 Month 05 Day
Date of IRB
Anticipated trial start date
2015 Year 09 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
2015 Year 08 Month 24 Day
Last modified on
2018 Year 05 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020416

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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