UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Impact of olopatadine hydrochloride(allelock(R)) against scratching behavior of atopic dermatitis patients at night.
Title of the study (Brief title)	Impact of olopatadine hydrochloride(allelock(R)) against scratching behavior of atopic dermatitis patients at night.
Region	Japan

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

Objectives
Narrative objectives1	1)To measure, collect, and analyze the data of scratching ratio from atopic dermatitis patients by wearing a scratching sound measuring instrument developed at Mie University. 2)Compare the scratching ratio and dermatitis severity. 3)To measure brain waves using electroencephalograph from the subjects obtained the informed consent. 4)Analyze the relation between scratch ratio and electroencephalograph (grade of deep sleep and sleep arousal). 5)The analysis of the effect of antihistamine medication for the prevention of the scratching and quality of sleep.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Measurement of the scratching ratio and depth of the sleep. The measurement will be performed on the day -2, -1 and 7 for atopic dermatitis patients. The measurement on day 7 day can be extended up to other 3 days, in case the subject is not available on day7. The VAS value of itch and the dermatitis score (EASI,ELQI) are measured for atopic dermatitis patient. Medication and the measurement on day 7 will not be performed for the healthy individuals.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	In addition to the usual treatment(topical medicine), use the tested product.
Interventions/Control_2	In addition to the usual treatment(topical medicine), use the placebo.
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Persons with severe or moderate disease severity classification defined by atopic dermatitis Japanese Dermatological Association. 2)18 years of age or older (at the time of obtaining informed consent) 3)Unquestioned gender. 4)Outpatient 5)Persons with voluntary documented consent form. 6)Who with night itching.
Key exclusion criteria	1)Those who may be pregnant or possible pregnant. 2)Those who have critical renal dysfunction and an impaired liver function. 3)The person under the specific or nonspecific de-sensitization treatment. 4)Those who took or injected a steroid, methotrexate, and cyclosporin in two weeks of the test . 5)Those who took the antihistamine within one week before the trial. 6)Those who have been engaged in business, such as operation of the car or machine. 7)The patient who is under the treatment of PUVA therapy using photo-senstive pills. 8)The patient with hypersensitivity or a drug-induced organ injury in the past with the use of Olopatadine, such as a Olopatadine hydrochloride (areroc(R)) and eye-drops Patanol (R). 9)Have lactose intolerance. 10)The person who is unsuitable for the entry judged by a doctor.
Target sample size	25

Research contact person
Name of lead principal investigator	Keiichi Yamanaka, M.D.,Ph.D.
Organization	Mie University, Graduate School of Medicine
Division name	Department of Dermatology
Address	2-174 Edobashi, Tsu, Mie 514-8507, Japan
TEL
Email

Public contact
Name of contact person
Organization	Mie University, Graduate School of Medicine
Division name	Department of Dermatology
Address
TEL	059-231-5422
Homepage URL
Email

Sponsor
Institute	Mie University, Graduate School of Medicine
Institute
Department

Funding Source
Organization	Kyowa Hakko Kirin Co., Ltd
Organization
Division
Category of Funding Organization	Profit organization
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	問診：三重大学医学部附属病院（三重県）　睡眠時測定：津都ホテル（三重県）

Other administrative information
Date of disclosure of the study information	2013 Year 04 Month 17 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 02 Month 12 Day
Anticipated trial start date	2013 Year 04 Month 18 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	Published
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 04 Month 17 Day
Last modified on	2018 Year 03 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012289