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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024665
Receipt No. R000028371
Scientific Title Assessment of nocturnal scratching activity in atopic dermatitis patients with scratching-detecting device
Date of disclosure of the study information 2016/11/18
Last modified on 2017/04/13

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Basic information
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
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
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

Public contact
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

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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
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

Progress
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
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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