UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034029
Receipt number R000038791
Scientific Title Epidemiology of zoster in Miyazaki Prefecture
Date of disclosure of the study information 2018/09/05
Last modified on 2024/03/09 10:01:07

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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 Kimiyasu
Middle name
Last name Shiraki

Organization

Senri Kinran University

Division name

Department of Nursing

Zip code

565-0873

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 Kimiyasu
Middle name
Last name Shiraki

Organization

Senri Kinran University

Division name

Department of Nursing

Zip code

565-0873

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 or person

Institute

Senri Kinran University

Institute

Department

Personal name



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

Senri KinranUniversity, Ethics committee

Address

5-52-1 Fujishirodai, Suita, Osaka 565-0873, Japan

Tel

06-6872-0673

Email

adm@.cs.kinran.ac.jp


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

1. J Dermatol Sci. 2021 Dec;104(3):185-92.
2. J Dermatol Sci. 2018 92:284-6.
3. J Dermatol Sci. 2018 92:89-96.
4. J Dermatol Sci. 2018 90:166-71.
5. Open Forum Infect Dis. 2017 4:ofx007.
6. J Med Virol. 2009 81:2053-8.


"Universal varicella vaccination" and "COVD-19 pandemic response" have been reported in reference 1. We started to analyze the recurrence of herpes zoster of 2,601 patients.

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

2018 Year 06 Month 04 Day

Anticipated trial start date

2018 Year 05 Month 01 Day

Last follow-up date

2025 Year 03 Month 31 Day

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

2024 Year 03 Month 09 Day



Link to view the page

Value
https://center6.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