UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	An epidemiological study on the prevalence of pruritus in patients with dementia
Title of the study (Brief title)	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	Akihiko Ikoma
Organization	Nestle Skin Health
Division name	SHIELD Asia Pacific
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	Akihiko Ikoma
Organization	Nestle Skin Health
Division name	SHIELD Asia Pacific
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 12 Month 15 Day
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

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Publication of results	Unpublished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