Palmoplantar PustulosisNCT04566471
Palmoplantar Pustulosis and Generalized Pustular Psoriasis: A National Population-based Analysis of Prevalence
An observational study of Palmoplantar Pustulosis and Generalized Pustular Psoriasis, run by Peking University Third Hospital.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Palmoplantar Pustulosis, Generalized Pustular Psoriasis
- What is being tested?
- prevalence/incidence
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2012to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
- Being tested
- prevalence/incidence
- Keywords
- Generalized pustular psoriasis, Palmoplantar pustulosis, Urban Employee Basic Medical Insurance (UEBMI) data, prevalence, incidence
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prevalence/incidenceOther
It is an observational study for prevalence/incidence, no intervention provided.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: prevalence/incidence |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of Palmoplantar pustulosis
Epidemiological characteristics of diseases: Mainly referring to indicators that could reflect the frequency related to the disease
Measured: 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
Measured: From 2012 to 2016 in the Urban Employee Basic Medical Insurance (UEBMI) data of China
Secondary outcomes (4)
incidence of Palmoplantar pustulosis
Epidemiological characteristics of diseases: Mainly referring to indicators that could reflect the frequency related to the disease
Measured: From 2012 to 2016 in the Urban Employee Basic Medical Insurance (UEBMI) data of China
incidence of Generalized pustular psoriasis
Epidemiological characteristics of diseases: Mainly referring to indicators that could reflect the frequency related to the disease
Measured: From 2012 to 2016 in the Urban Employee Basic Medical Insurance (UEBMI) data of China
Economic burden of Palmoplantar pustulosis
Mainly referring to the consumption of medical resources, including medical expenses of patients.
Measured: From 2012 to 2016 in the Urban Employee Basic Medical Insurance (UEBMI) data of China
Economic burden of Generalized pustular psoriasis
Mainly referring to the consumption of medical resources, including medical expenses of patients.
Measured: From 2012 to 2016 in the Urban Employee Basic Medical Insurance (UEBMI) data of China
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study start1 Jan 2012
- Primary completion1 Dec 2016
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palmoplantar PustulosisStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Siyan Zhan, PhD, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04566471
- Sponsor's protocol ID
- BI13680065
- Status last verified
- Jun 2020
- First submitted
- 22 Sep 2020
- Last updated
- 28 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palmoplantar Pustulosis and Generalized Pustular Psoriasis: A National Population-based Analysis of Prevalence
- ClinicalTrials.gov ID
- NCT04566471
- Acronym / sponsor ID
- BI13680065
- Keywords
- Generalized pustular psoriasis, Palmoplantar pustulosis, Urban Employee Basic Medical Insurance (UEBMI) data, prevalence, incidence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 1 Dec 2016 (actual)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 28 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PPP and GPP | – | Other: prevalence/incidencePalmoplantar 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prevalence/incidenceIt is an observational study for prevalence/incidence, no intervention provided. | Other | PPP and GPP |
Primary outcome
prevalence of Palmoplantar pustulosis
Time frame: From 2012 to 2016 in the Urban Employee Basic Medical Insurance (UEBMI) data of China
Epidemiological characteristics of diseases: Mainly referring to indicators that could reflect the frequency related to the disease
prevalence of Generalized pustular psoriasis
Time frame: From 2012 to 2016 in the Urban Employee Basic Medical Insurance (UEBMI) data of China
Epidemiological characteristics of diseases: Mainly referring to indicators that could reflect the frequency related to the disease
4 secondary outcomes
incidence of Palmoplantar pustulosis
Time frame: From 2012 to 2016 in the Urban Employee Basic Medical Insurance (UEBMI) data of China
incidence of Generalized pustular psoriasis
Time frame: From 2012 to 2016 in the Urban Employee Basic Medical Insurance (UEBMI) data of China
Economic burden of Palmoplantar pustulosis
Time frame: From 2012 to 2016 in the Urban Employee Basic Medical Insurance (UEBMI) data of China
Economic burden of Generalized pustular psoriasis
Time frame: From 2012 to 2016 in the Urban Employee Basic Medical Insurance (UEBMI) data of China
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Siyan Zhan, PhD principal investigator
Peking University Third Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Palmoplantar Pustulosis and Generalized Pustular Psoriasis, run by Peking University Third Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of Palmoplantar pustulosis (time frame: From 2012 to 2016 in the Urban Employee Basic Medical Insurance (UEBMI) data of China). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2020.