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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025583
Receipt No. R000029441
Scientific Title An epidemiological study on the prevalence of pruritus in patients with dementia
Date of disclosure of the study information 2017/01/09
Last modified on 2017/05/24

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Basic information
Public title An epidemiological study on the prevalence of pruritus in patients with dementia
Acronym An epidemiological study on the prevalence of pruritus in patients with dementia
Scientific Title An epidemiological study on the prevalence of pruritus in patients with dementia
Scientific Title:Acronym An epidemiological study on the prevalence of pruritus in patients with dementia
Region
Japan Asia(except Japan) North America

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

Objectives
Narrative objectives1 Estimating the prevalence of pruritus in patients with dementia as well as investigating its potential correlations with other factors.

Primary objective:
* Estimating the prevalence of pruritus in patients with dementia.

Secondary objectives:
* Investigating the correlation of staging of dementia with pruritus severity.
* Investigating the correlation of skin care with pruritus severity.
Basic objectives2 Others
Basic objectives -Others Epidemiological study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes * Demography: Age, gender, race, type of dementia, medical history, and skin care
* Staging of dementia
* Itch evaluation: Self-evaluation of itch (by patients), evaluation of scratching behavior (by families), and evaluation of skin scratching marks and dry skin (by investigators or designees)
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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) Adult male or female subjects with a diagnosis of dementia.
(2) Subjects whose legal representative fully understands this study and gives informed consent in writing for the participation in the study. Both the subject and his/her legal representative give informed consent in writing if the subject has ability to understand the study and to give informed consent to participate in the study in writing.
(3) Subjects whose legal representative gives informed consent in writing to offer the subject's personal information and research data including those obtained before starting the study. Both the subject and his/her legal representative give informed consent in writing if the subject has ability to understand and to give informed consent in writing.
Key exclusion criteria (1) Subjects whom the principal investigator or the study cooperator considers inappropriate as participant in this study.
Target sample size 300

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 Galderma K.K. Shinjuku Grand Tower, 34F, 8-17-1, Nishi-Shinjuku, Shinjuku-ku Tokyo 160-6134, Japan
TEL +81-3-5937-3850
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 Galderma K.K. Shinjuku Grand Tower, 34F, 8-17-1, Nishi-Shinjuku, Shinjuku-ku Tokyo 160-6134, Japan
TEL +81-3-5937-3850
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 Outside Japan
Nationality of Funding Organization

Other related organizations
Co-sponsor Chitofuna Dermatology Clinic
Takase Clinic
Benesse Style Care Co., Ltd.
Saint-Care Holding Corporation
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
2017 Year 01 Month 09 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 12 Month 15 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Recruiting

Management information
Registered date
2017 Year 01 Month 09 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=R000029441

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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