UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Assessment of nocturnal scratching activity in atopic dermatitis patients with scratching-detecting device
Title of the study (Brief title)	Assessment of nocturnal scratching activity in atopic dermatitis patients with scratching-detecting device
Region	Japan

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

Objectives
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

Assessment
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

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
Name of lead principal investigator	Michio Yagi
Organization	Medical Corporation Heishinkai OPHAC Hospital
Division name	Medical office
Address	4-1-29 Miyahara, Yodogawa-ku, Osaka-shi, Osaka 532-0003 JAPAN
TEL	06-6395-9000
Email	michio.yagi@heishinkai.com

Public contact
Name of contact person	Michio Yagi
Organization	Medical Corporation Heishinkai OPHAC Hospital
Division name	Medical office
Address	4-1-29 Miyahara, Yodogawa-ku, Osaka-shi, Osaka 532-0003 JAPAN
TEL	06-6395-9000
Homepage URL
Email	michio.yagi@heishinkai.com

Sponsor
Institute	Nestle Skin Health S.A.
Institute
Department

Funding Source
Organization	Nestle Skin Health S.A.
Organization
Division
Category of Funding Organization	Outside Japan
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	2016 Year 11 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 11 Month 17 Day
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

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Publication of results	Unpublished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

Management information
Registered date	2016 Year 11 Month 01 Day
Last modified on	2017 Year 04 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028371