UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on the positive rate of skin prick test to the secreted protein of Malassezia
Title of the study (Brief title)	Skin prick test to the secreted protein of Malassezia
Region	Japan

Condition
Condition	Atopic dermatitis
Classification by specialty	Dermatology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the positive rate of skin prick test to the secreted protein of Malassezia in patients with atopic dermatitis and healthy controls
Basic objectives2	Others
Basic objectives -Others	positive rate of skin prick test
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Wheal and erythema induced by skin prick test to the purified-secreted protein of Malassezia
Key secondary outcomes	Estimate of safety of skin prick test. anaphylaxis after 15 min of SPT, and itch, exacerbation of eczema, late-phase skin induration, secondary infection

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	Diagnosis
Type of intervention	Other
Interventions/Control_1	Skin prick test (once) of the secreted protein of Malassezia
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	(a) Subject is the age of 20 or older. (b) Subject visits our outpatient clinic. (c) Subject is a healthy volunteer or a patient with atopic dermatitis. (d) Subject provides written informed consent.
Key exclusion criteria	(a) Subject cannot stop antihistamine for two days. (b) Subject is pregnant or possibly pregnant. (c) Subject is excluded by a primary doctor.
Target sample size	20

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

Public contact
Name of contact person	Takaaki Hiragun
Organization	Hiroshima University
Division name	Department of Dermatology
Address	1-2-3 Kasumi, Minami-ku, Hiroshima, Japan
TEL	082-257-5237
Homepage URL
Email	hiragunt@hiroshima-u.ac.jp

Sponsor
Institute	Department of Dermatology, Integrated Health Sciences, Institute of Biomedical and Health Sciences, Hiroshima University
Institute
Department

Funding Source
Organization	Department of Dermatology, Integrated Health Sciences, Institute of Biomedical and Health Sciences, Hiroshima University
Organization
Division
Category of Funding Organization	Self funding
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	広島大学病院（広島県）

Other administrative information
Date of disclosure of the study information	2013 Year 07 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 06 Month 30 Day
Anticipated trial start date	2013 Year 07 Month 02 Day
Last follow-up date	2016 Year 12 Month 31 Day
Date of closure to data entry	2017 Year 01 Month 30 Day
Date trial data considered complete	2017 Year 02 Month 28 Day
Date analysis concluded	2017 Year 06 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 06 Month 26 Day
Last modified on	2017 Year 03 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012238