NCT04566471

Brief Summary

This study plans to calculate the prevalence and incidence of palmoplantar pustulosis and generalized pustular psoriasis based on the national medical insurance data and analyze the composition characteristics and some clinical features of patients, through taking into account of the research status of palmoplantar pustulosis and generalized pustular psoriasis and the characteristics of medical insurance data.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

September 22, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 28, 2020

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

September 28, 2020

Status Verified

June 1, 2020

Enrollment Period

4.9 years

First QC Date

September 22, 2020

Last Update Submit

September 22, 2020

Conditions

Keywords

Generalized pustular psoriasisPalmoplantar pustulosisUrban Employee Basic Medical Insurance (UEBMI) dataprevalenceincidence

Outcome Measures

Primary Outcomes (2)

  • prevalence of Palmoplantar pustulosis

    Epidemiological characteristics of diseases: Mainly referring to indicators that could reflect the frequency related to the disease

    From 2012 to 2016 in the Urban Employee Basic Medical Insurance (UEBMI) data of China

  • prevalence of Generalized pustular psoriasis

    Epidemiological characteristics of diseases: Mainly referring to indicators that could reflect the frequency related to the disease

    From 2012 to 2016 in the Urban Employee Basic Medical Insurance (UEBMI) data of China

Secondary Outcomes (4)

  • incidence of Palmoplantar pustulosis

    From 2012 to 2016 in the Urban Employee Basic Medical Insurance (UEBMI) data of China

  • incidence of Generalized pustular psoriasis

    From 2012 to 2016 in the Urban Employee Basic Medical Insurance (UEBMI) data of China

  • Economic burden of Palmoplantar pustulosis

    From 2012 to 2016 in the Urban Employee Basic Medical Insurance (UEBMI) data of China

  • Economic burden of Generalized pustular psoriasis

    From 2012 to 2016 in the Urban Employee Basic Medical Insurance (UEBMI) data of China

Study Arms (1)

PPP and GPP

Palmoplantar pustulosis (PPP) and Generalized pustular psoriasis (GPP) are rare chronic inflammatory skin diseases, characterized by repeated episodes of sterile pustules in several months or years, associated with erythrokeratodermia generally. Both two diseases are easy to cause skin rupture, leading to bleeding and pain.

Other: prevalence/incidence

Interventions

It is an observational study for prevalence/incidence, no intervention provided.

PPP and GPP

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study used the Urban Employee Basic Medical Insurance (UEBMI) data from 2012 to 2016 to calculate the epidemiological characteristics of palmoplantar pustulosis and generalized pustular psoriasis. The database includes basic medical insurance data for urban workers and basic medical insurance data for urban residents, which covers 31 provinces, municipalities and autonomous regions. By the end of 2016, the number of people participating in the national basic medical insurance exceeded 1.3 billion, and the coverage rate of the insurance was stable at over 95%. The database is composed of an insurance coverage database and a reimbursement settlement database. The insurance coverage database involves demographic information, insurance information and payment information; and the reimbursement settlement database involves medical information, disease information and expense information.

You may qualify if:

  • The insured population of the national urban employee basic medical insurance and the urban resident basic medical insurance from January 1, 2012, to December 31, 2016 (60 months) (the denominator)
  • The patients have been diagnosed with palmoplantar pustulosis or generalized pustular psoriasis (including disease name, English abbreviation and ICD code)
  • Both outpatient and inpatient patients are included

You may not qualify if:

  • The individuals whose information is only contained in the reimbursement settlement database but not in the insurance coverage database will be considered as invalid reimbursement individuals and be excluded from the study (the denominator)
  • The patients have been diagnosed with non-PPP and -GPP diseases, such as pustular psoriasis in palm and toe, pustular arthritis osteitis and SAPHO syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Psoriasis

Interventions

PrevalenceIncidence

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

MorbidityVital StatisticsData CollectionEpidemiologic MethodsInvestigative TechniquesDemographyPopulation CharacteristicsEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Siyan Zhan, PhD

    Peking University Third Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2020

First Posted

September 28, 2020

Study Start

January 1, 2012

Primary Completion

December 1, 2016

Study Completion

December 31, 2021

Last Updated

September 28, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share