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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027477
Receipt No. R000031480
Scientific Title Assessment on usability of itch evaluation by application program to measure scratching
Date of disclosure of the study information 2017/05/25
Last modified on 2017/05/24

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Basic information
Public title Assessment on usability of itch evaluation by application program to measure scratching
Acronym Usability of itch evaluation by scratching mesurement app
Scientific Title Assessment on usability of itch evaluation by application program to measure scratching
Scientific Title:Acronym Usability of itch evaluation by scratching mesurement app
Region
Japan

Condition
Condition pruritus
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Assessment on correlation between scratching measured by smartwatch and traditional self-evaluated itch in patients with chronic pruritus
Basic objectives2 Others
Basic objectives -Others Assessment on usability of applying scratching measurement to evaluate efficacy of treatment
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes scratching time
self-evaluated itch severity
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 oral and topical medications that are usual for the indication. Treatment period is unrestricted, depending on necessity of each participant.
Interventions/Control_2
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Patients with pruritus or pruritic diseases
2. Patients who or whose legal representative can give informed consent to participation in writing.
Key exclusion criteria 1.Patients who or whose legal representative cannot give informed consent.
2. Staff or family of the study organization.
3. Other patients who the investigator judges not applicable to participate.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akihiko Ikoma
Organization Nestle Skin Health
Division name SHIELD Asia Pacific
Zip code
Address 3-5-8 Kami-Ohsaki, Shinagawa-ku, Tokyo
TEL 03-6628-6600
Email akihiko.ikoma@galderma.com

Public contact
Name of contact person
1st name
Middle name
Last name Akihiko Ikoma
Organization Nestle Skin Health
Division name SHIELD Asia Pacific
Zip code
Address 3-5-8 Kami-Ohsaki, Shinagawa-ku, Tokyo
TEL 03-6628-6600
Homepage URL
Email akihiko.ikoma@galderma.com

Sponsor
Institute Nestle Skin Health
Institute
Department

Funding Source
Organization Nestle Skin Health
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Chitofuna Dermatology Clinic
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 ちとふな皮膚科クリニック

Other administrative information
Date of disclosure of the study information
2017 Year 05 Month 25 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 Enrolling by invitation
Date of protocol fixation
2017 Year 03 Month 06 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 05 Month 24 Day
Last modified on
2017 Year 05 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031480

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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