UMIN-CTR Clinical Trial

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	In October 2014, universal varicella vaccine was introduced. The relationship between varicella and herpes zoster was a mirror image. Varicella reduced and its seasonality is lost. Therefore, we are currently examining the seasonal changes in herpes zoster. 1.Toyama et al. J Dermatol Sci. 2018 92:284-286. 2.Toyama et al. J Dermatol Sci. 2018 92:89-96. 3.Shiraki et al. J Dermatol Sci. 2018 90:166-171. 4.Shiraki et al. Open Forum Infect Dis. 2017 4:ofx007. 5.Toyama et al. J Med Virol. 2009 81:2053-8.
Results date posted	2020 Year 03 Month 05 Day
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	2020 Year 03 Month 05 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
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