UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000025583
Receipt number	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 17:04:18

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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

dementia
pruritus

Classification by specialty

Neurology Dermatology

Classification by malignancy

Others

Genomic information

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 or person

Institute

Nestle Skin Health

Institute

Department

Personal name

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

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Value
https://center6.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