UMIN-CTR Clinical Trial

Public title

Impact of olopatadine hydrochloride(allelock(R)) against scratching behavior of atopic dermatitis patients at night.

Acronym

Impact of olopatadine hydrochloride(allelock(R)) against scratching behavior of atopic dermatitis patients at night.

Scientific Title

Impact of olopatadine hydrochloride(allelock(R)) against scratching behavior of atopic dermatitis patients at night.

Scientific Title:Acronym

Impact of olopatadine hydrochloride(allelock(R)) against scratching behavior of atopic dermatitis patients at night.

Region

Japan

Condition

Atopic dermatitis

Classification by specialty

Dermatology

Adult

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Keiichi Yamanaka, M.D.,Ph.D.

Organization

Mie University, Graduate School of Medicine

Division name

Department of Dermatology

Zip code

Address

2-174 Edobashi, Tsu, Mie 514-8507, Japan

TEL

Email

Name of contact person

1st name
Middle name
Last name

Organization

Mie University, Graduate School of Medicine

Division name

Department of Dermatology

Zip code

Address

TEL

059-231-5422

Homepage URL

Email

Institute

Mie University, Graduate School of Medicine

Institute

Department

Personal name

Organization

Kyowa Hakko Kirin Co., Ltd

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2013

Year

04

Month

17

Day

URL releasing protocol

Publication of results

Published

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

Recruitment status

Completed

Date of protocol fixation

2013

Year

02

Month

12

Day

Date of IRB

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

Other related information

Registered date

2013

Year

04

Month

17

Day

Last modified on

2018

Year

03

Month

29

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012289