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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034029
Receipt No. R000038791
Scientific Title Epidemiology of zoster in Miyazaki Prefecture
Date of disclosure of the study information 2018/09/05
Last modified on 2019/03/06

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Basic information
Public title Epidemiology of zoster in Miyazaki Prefecture
Acronym Epidemiology of zoster
Scientific Title Epidemiology of zoster in Miyazaki Prefecture
Scientific Title:Acronym Epidemiology of zoster
Region
Japan

Condition
Condition Herpes zoster
Classification by specialty
Infectious disease Dermatology Adult
Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Incidence including the first and second episodes of zoster and underlying diseases.
Dermatome distribution of herpes zoster.
Analysis of pathogenesis of herpes zoster.
Analysis of the effect of universal varicella vaccination on the epidemiology of herpes zoster.
Basic objectives2 Others
Basic objectives -Others Interval and dermatomes of the first and second episodes
Dermatome distribution in herpes zoster
pathogenesis analysis from the distribution and seasonality, age, and gender, etc. of herpes zoster.
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Age, gender, interval, and dermatomes of the first and second episodes
Characterization of distribution of herpes zoster
Analysis of pathogenesis of herpes zoster from seasonality, age and gender, etc.
Key secondary outcomes The presence and absence of underlying disease(s)

Characterization of herpes zoster pathogenesis

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 Patients with herpes zoster who visited the members of the society of the Miyazaki Dermaotolist Society. Patients with herpes zoster were monitored only the first visit to the member and patients were excluded the second visit and visit from the herpes zoster pain to avoid the double counting of the number of patents with herpes zoster.
Key exclusion criteria The patient who declined to be involved in this survey.
Target sample size 200000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kimiyasu Shiraki
Organization Senri Kinran University
Division name Department of Nursing
Zip code
Address 5-52-1 Fujishirodai, Suita, Osaka 565-0873, Japan
TEL +81-6-6872-0673
Email k-shiraki@cs.kinran.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kimiyasu Shiraki
Organization Senri Kinran University
Division name Department of Nursing
Zip code
Address 5-52-1 Fujishirodai, Suita, Osaka 565-0873, Japan
TEL +81-6-6872-0673
Homepage URL
Email k-shiraki@cs.kinran.ac.jp

Sponsor
Institute Senri Kinran University
Institute
Department

Funding Source
Organization University cost
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Miyazaki Dermatologist Society (Dr. Nozomu Toyama)
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 UMIN000034029
Org. issuing International ID_1 UMIN000034029
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 09 Month 05 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Total accumulated number of herpes zoster has increased and the tendency of annual changes are under analysis.
1.Toyama N; Miyazaki Dermatologist Society, Shiraki K; Miyazaki Dermatologist Society.
Universal varicella vaccination reduced the incidence of herpes zoster in vaccine recipients 1 to 4 years of age.
J Dermatol Sci. 2018 Dec;92(3):284-286. doi: 10.1016/j.jdermsci.2018.11.001. Epub 2018 Nov 13. No abstract available.

2.Toyama N, Shiraki K; Miyazaki Dermatologist Society.
Universal varicella vaccination increased the incidence of herpes zoster in the child-rearing generation as its short-term effect.
J Dermatol Sci. 2018 Oct;92(1):89-96. doi: 10.1016/j.jdermsci.2018.07.003. Epub 2018 Jul 10.

3.Shiraki K, Toyama N, Shiraki A, Yajima M; Miyazaki Dermatologist Society.
Age-dependent trigeminal and female-specific lumbosacral increase in herpes zoster distribution in the elderly.
J Dermatol Sci. 2018 May;90(2):166-171. doi: 10.1016/j.jdermsci.2018.01.009. Epub 2018 Jan 31.

4.Shiraki K, Toyama N, Daikoku T, Yajima M; Miyazaki Dermatologist Society.
Herpes Zoster and Recurrent Herpes Zoster.
Open Forum Infect Dis. 2017 Jan 28;4(1):ofx007. doi: 10.1093/ofid/ofx007. eCollection 2017 Winter.

5.Toyama N, Shiraki K; Society of the Miyazaki Prefecture Dermatologists.
Epidemiology of herpes zoster and its relationship to varicella in Japan: A 10-year survey of 48,388 herpes zoster cases in Miyazaki prefecture.
J Med Virol. 2009 Dec;81(12):2053-8. doi: 10.1002/jmv.21599.
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 Open public recruiting
Date of protocol fixation
2018 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This epidemiological study is a continuation study of the following epidemiological study. The number of approval from the ethics committee of Senri Kinran University is "K18-003."

Title:Epidemiology of herpes zoster in Miyazaki Prefecture.
UMIN registry ID: UMIN000005261
Umin receipt ID: R000006256

Management information
Registered date
2018 Year 09 Month 04 Day
Last modified on
2019 Year 03 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038791

Research Plan
Registered date File name
2018/09/24 千里金蘭大学「疫学研究実施計画審査申請書」修正版.doc

Research case data specifications
Registered date File name

Research case data
Registered date File name


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