UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053107 |
|---|---|
| Receipt number | R000060600 |
| Scientific Title | Cutaneous adverse events following the COVID-19 vaccination: a case series of 30 Japanese patients and a review of 93 Japanese studies |
| Date of disclosure of the study information | 2023/12/14 |
| Last modified on | 2023/12/14 15:49:12 |
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Basic information
Public title
Cutaneous adverse events following the COVID-19 vaccination: a case series of 30 Japanese patients and a review of 93 Japanese studies
Acronym
Cutaneous adverse events following the COVID-19 vaccination: a case series of 30 Japanese patients and a review of 93 Japanese studies
Scientific Title
Cutaneous adverse events following the COVID-19 vaccination: a case series of 30 Japanese patients and a review of 93 Japanese studies
Scientific Title:Acronym
Cutaneous adverse events following the COVID-19 vaccination: a case series of 30 Japanese patients and a review of 93 Japanese studies
Region
| Japan |
Condition
Condition
Cutameous adverse events to COVID-19 vaccination
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In late 2019, coronavirus disease 2019 (COVID-19), first reported in Wuhan, China, triggered by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), swiftly spread worldwide and was declared a global pandemic by the World Health Organization. An enormous number of people have been infected, resulting in morbidity and mortality. To reduce COVID-19 aggravation within Japan, there was a need to increase vaccination coverage; accordingly, the BNT162b2 (Pfizer-BioNTech) vaccine was approved on February 14, 2021, followed by the mRNA-1273 (Moderna/Takeda) and ChAdOx1-S (AstraZeneca) vaccines on May 21, 2021, and NVX-CoV2373 (Novavax/Takeda) on April 19, 2022.
Basic objectives2
Others
Basic objectives -Others
Although vaccines were effective in most cases at protecting people from developing serious symptoms and being hospitalized, some people showed cutaneous adverse events (AEs). While a considerable amount of time has passed since the first worldwide vaccination effort, Japan has yet to establish a national database of cutaneous AEs in vaccinated people that can be actively monitored. Cutaneous reactions following COVID-19 vaccination in Japanese people have been described in single case reports as well as in a few small case series and reviews; however, these reports are insufficient to understand cutaneous AEs. As single-center case series with non-selected patients are lacking, we aimed to analyze patients with cutaneous AEs after COVID-19 vaccination in our hospital and review previous studies of cutaneous AEs. To our knowledge, this is the largest long-term single-center study including booster vaccination doses performed in a department of dermatology at a public hospital in Japan.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
This study was approved by the Medical Ethics Committee of Kagoshima City Hospital, Kagoshima, Japan (No 2021-47). A case series analysis was conducted at our hospital, and all patients with skin manifestations within 30 days or less following the COVID-19 vaccination were enrolled. All patients included in our study were diagnosed based on clinical and/or histopathological evaluations, and all other possible differential diagnoses were excluded. Next, we extracted cutaneous AEs induced by COVID-19 vaccines reported to the Ministry of Health, Labor, and Welfare,3 categorized them, and counted the number of cases. Finally, we performed a literature review by searching PubMed, Google Scholar, and Ichushi Web Library databases for articles about Japanese cases of cutaneous manifestations after COVID-19 vaccination between April 2021 and March 2023 written in English or Japanese. We considered cases or studies describing patients with new-onset or pre-existing skin disease following COVID-19 vaccination eligibility and excluded studies with unknown vaccine types and insufficient diagnoses.
Results are expressed as mean SD. Comparisons between the two groups were performed using Welch s t-tests. Differences with p 0.05 were considered significant.
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
| 12 | years-old | <= |
Age-upper limit
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
All patients with skin manifestations within 30 days or less following the COVID-19 vaccination
Key exclusion criteria
All patients included in our study were diagnosed based on clinical and/or histopathological evaluations, and all other possible differential diagnoses were excluded.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Atsunori |
| Middle name | |
| Last name | Baba |
Organization
Kagoshima City Hospital
Division name
Department of Dermatology
Zip code
8908760
Address
1-37 Uearata-cho, Kagoshima, Japan
TEL
0992307000
baba-a16@kch.kagoshima.jp
Public contact
Name of contact person
| 1st name | Atsunori |
| Middle name | |
| Last name | Baba |
Organization
Kagoshima City Hospital
Division name
Department of Dermatology,
Zip code
8908760
Address
1-37 Uearata-cho, Kagoshima, Japan
TEL
0992307000
Homepage URL
baba-a16@kch.kagoshima.jp
Sponsor or person
Institute
Kagoshima City Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kagoshima City Hospital
Address
1-37 Uearata-cho, Kagoshima, Japan
Tel
0992307000
kch-kenkyu@kch.kagoshima.jp
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
| 2023 | Year | 12 | Month | 14 | 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
30
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
| 2021 | Year | 02 | Month | 24 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 16 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2023 | Year | 12 | Month | 14 | Day |
Last modified on
| 2023 | Year | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060600
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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