UMIN-CTR Clinical Trial

Public title

Assessment of nocturnal scratching activity in atopic dermatitis patients with scratching-detecting device

Acronym

Assessment of nocturnal scratching activity in atopic dermatitis patients with scratching-detecting device

Scientific Title

Assessment of nocturnal scratching activity in atopic dermatitis patients with scratching-detecting device

Scientific Title:Acronym

Assessment of nocturnal scratching activity in atopic dermatitis patients with scratching-detecting device

Region

Japan

Condition

Atopic dermatitis

Classification by specialty

Dermatology

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Step 1
Assessment of performances including sensitivity and specificity of scratching-detecting device for nocturnal scratching activity in patients with atopic dermatitis.

Step 2
Investigation of correlation between nocturnal scratching activity and intensity of atopic dermatitis. Comparison of nocturnal scratching activity between atopic dermatitis patients and healthy adults.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Step 1
･Overall evaluation the performance of the scratching-detecting device including sensitivity, specificity, and positive predictive value
･Adverse events / adverse drug reactions

Step 2
･Comparison of accumulative time of nocturnal scratching activity between atopic dermatitis patients and healthy adults
･Correlation of nocturnal scratching activity with intensity of atopic dermatitis and with intensity of self-evaluated itch and sleep disturbance
･Adverse events / adverse drug reactions

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Diagnosis

Type of intervention

Other

Interventions/Control_1

Measuring nocturnal scratching activity with scratching-detecting device (n=5)

Interventions/Control_2

Comparison of nocturnal scratching activity between atopic dermatitis patients (n=20) and healthy adults (n=10)

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

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Step 1
1) The subject with a diagnosis of atopic dermatitis based on 'Definition and diagnostic criteria for atopic dermatitis' by the Japanese Dermatological Association
2) The subject aged >= 20 years at the time of informed consent.
3) The moderate to severe atopic dermatitis patients with > score 7 in Eczema Area and Severity Index (EASI).
4) The subject with mean itch score >= 5 in Numerical Rating Scale (NRS) during 7 days before the measurement. Itch intensity is self-measured on a 10-pt numerical scale, where 0 = no itch and 10 = worst possible itch.
5) The subject with itch score >= 5 in NRS on the measurement day.
6) The subject without change in treatment including atopic dermatitis during 7 days before the measurement.
7) The subject usually takes >= 4 hours of nocturnal sleep.
8) The subject gives informed consent in writing for the participation in this study including video shooting of nocturnal sleep.

Step 2
Atopic dermatitis patients
1) The subject with a diagnosis of atopic dermatitis based on 'Definition and diagnostic criteria for atopic dermatitis' by the Japanese Dermatological Association.
2) The subject aged >= 20 years at the time of informed consent.
3) The subject without change in treatment including atopic dermatitis during 7 days before the measurement.
4) The subject gives informed consent in writing for the participation in this study.

Healthy Adults
1) The subject aged >= 20 years at the time of informed consent.
2) The subject who is assessed as healthy by the principal investigator or subinvestigators.
3) The subject with mean itch score 0 in NRS during 7 days before the measurement. Short-time mild itch induced by external stimulus is not assessed as significant.
4) The subject with itch score 0 in NRS on the measurement day. Short-time mild itch induced by external stimulus is not assessed as significant.
5) The subject gives informed consent in writing for the participation in this study.

Key exclusion criteria

Step 1
1) The subject has difficulty in making a decision by dementia or something.
2) The subject has a past medical history of disturbance of consciousness.
3) The subject is addicted to drug or alcohol.
4) The subject takes psychoactive drugs or meets indication for treatment of those drugs.
5) The subject has a serious complication of hepatic, renal, cardiac, hematological, endocrine, metabolic, pulmonary, or gastrointestinal disease.
6) Others who are assessed ineligible for this study by the principal investigator or subinvestigators.


Step 2
1) The subject has difficulty in making a decision by dementia or something.
2) The subject has a past medical history of disturbance of consciousness.
3) The subject is addicted to drug or alcohol.
4) The subject takes psychoactive drugs or meets indication for treatment of those drugs.
5) The subject has a serious complication of hepatic, renal, cardiac, hematological, endocrine, metabolic, pulmonary, or gastrointestinal disease.
6) Others who are assessed ineligible for this study by the principal investigator or subinvestigators.

Target sample size

35

Name of lead principal investigator

1st name
Middle name
Last name	Michio Yagi

Organization

Medical Corporation Heishinkai OPHAC Hospital

Division name

Medical office

Zip code

Address

4-1-29 Miyahara, Yodogawa-ku, Osaka-shi, Osaka 532-0003 JAPAN

TEL

06-6395-9000

Email

michio.yagi@heishinkai.com

Name of contact person

1st name
Middle name
Last name	Michio Yagi

Organization

Medical Corporation Heishinkai OPHAC Hospital

Division name

Medical office

Zip code

Address

4-1-29 Miyahara, Yodogawa-ku, Osaka-shi, Osaka 532-0003 JAPAN

TEL

06-6395-9000

Homepage URL

Email

michio.yagi@heishinkai.com

Institute

Nestle Skin Health S.A.

Institute

Department

Personal name

Organization

Nestle Skin Health S.A.

Organization

Division

Category of Funding Organization

Outside Japan

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

Date of disclosure of the study information

2016

Year

11

Month

18

Day

URL releasing protocol

Publication of results

Unpublished

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

2016

Year

11

Month

17

Day

Date of IRB

Anticipated trial start date

2016

Year

11

Month

18

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

2017

Year

04

Month

13

Day

Other related information

Registered date

2016

Year

11

Month

01

Day

Last modified on

2017

Year

04

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028371