UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027477 |
|---|---|
| Receipt number | 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 17:02:19 |
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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
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
akihiko.ikoma@galderma.com
Sponsor or person
Institute
Nestle Skin Health
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031480
