UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination of the effect of hyposensitization therapy by sweat and Malassezia antigen
Title of the study (Brief title)	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	Michihiro Hide
Organization	Hiroshima University Hospital
Division name	Dermatology
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	Shunsuke Takahagi
Organization	Hiroshima University Hospital
Division name	Dermatology
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 08 Month 05 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000020416