PsoriasisNCT05943405
The Disease Severity In Patients With Psoriasis
An observational study of Psoriasis, run by Universitas Sebelas Maret at 1 site in Indonesia.
Trial summary
This observational study aims to evaluate new markers to predict disease activity in psoriasis. The main question is SGOT, SGPT, GGT, hs-CRP, and apo B related to disease severity in psoriasis. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Psoriasis
- How many people
- 33 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jun 2022to 30 Dec 2022
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Psoriasis Patients
Who may be able to join
- Clinical diagnosis of Psoriasis
Who cannot join
- Heart Failure
- Diabetes Mellitus
- Kidney Disease
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Universitas Sebelas Maret Hospital
Sukoharjo, Central Java, 57161
About this study
This observational study aims to evaluate new markers to predict disease activity in psoriasis. The main question is SGOT, SGPT, GGT, hs-CRP, and apo B related to disease severity in psoriasis.
Read the detailed description
Psoriasis patients who had signed an informed consent were assessed for PASI scores and 5 cc of blood was drawn for GGT, hs-CRP, and apo B examinations. A PASI score is a tool used to measure the severity and extent of psoriasis. PASI is an acronym for Psoriasis Area and Severity Index.
- Conditions
- Psoriasis
- Keywords
- Psoriasis, Psoriasis Area and Severity Index, Gamma-Glutamyl Transferase, CRP, Apolipoprotein B
- Medical subject headings
- Psoriasis
What is being measured
The primary outcome is the main question the study is designed to answer.
Gamma-Glutamyl Transferase
Gamma-Glutamyl Transferase was check in admission, reference range for adults is 5 to 40 U/L (units per liter)
Measured: only in admission
Apolipoprotein B
Apolipoprotein B (ApoB) is the primary apolipoprotein and is the carrier for the following lipids: chylomicrons, low-density lipoprotein ( LDL), very low-density lipoprotein (VLDL), intermediate-density lipoprotein (IDL), and lipoprotein. Unit used in mg/dL
Measured: only in admission
High-sensitivity c-reactive protein
High-sensitivity C-reactive protein (hsCRP) is a marker of inflammation that predicts incident myocardial infarction, stroke, peripheral arterial disease, and sudden cardiac death. Unit used in mg/L
Measured: only in admission
PASI
A PASI (The Psoriasis Area and Severity Index) score can range from 0 to 72
Measured: only in admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start1 Jun 2022
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Sebelas Maret
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurhasan Agung Prabowo, MD, Universitas Sebelas Maret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05943405
- Sponsor's protocol ID
- NAP07
- Status last verified
- Jul 2023
- First submitted
- 25 Jun 2023
- Last updated
- 13 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sholihah MM, Kusuma TRH, Hanif MI, Prabowo NA. Letter to the Editor on Type 1 diabetes onset triggered by COVID-19. Acta Diabetol. 2021 Sep;58(9):1283-1284. doi: 10.1007/s00592-021-01761-3. Epub 2021 Jun 28. No abstract available.
PubMed 34181079Pratama YS, Pradiptakirana R, Rachmah A, Prabowo NA. Autoimmune Thrombocytopenia in SLE and COVID-19. Eur J Case Rep Intern Med. 2021 Nov 3;8(11):002863. doi: 10.12890/2021_002863. eCollection 2021.
PubMed 34912736
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Disease Severity In Patients With Psoriasis
- ClinicalTrials.gov ID
- NCT05943405
- Acronym / sponsor ID
- NAP07
- Conditions
- Psoriasis
- Keywords
- Psoriasis, Psoriasis Area and Severity Index, Gamma-Glutamyl Transferase, CRP, Apolipoprotein B
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Universitas Sebelas MaretUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 13 Jul 2023 (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 observational study aims to evaluate new markers to predict disease activity in psoriasis. The main question is SGOT, SGPT, GGT, hs-CRP, and apo B related to disease severity in psoriasis.
Detailed description
Psoriasis patients who had signed an informed consent were assessed for PASI scores and 5 cc of blood was drawn for GGT, hs-CRP, and apo B examinations. A PASI score is a tool used to measure the severity and extent of psoriasis. PASI is an acronym for Psoriasis Area and Severity Index.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Psoriasis Patients
Key inclusion criteria (1 listed)
- Clinical diagnosis of Psoriasis
Key exclusion criteria (3 listed)
- Heart Failure
- Diabetes Mellitus
- Kidney Disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Gamma-Glutamyl Transferase
Time frame: only in admission
Gamma-Glutamyl Transferase was check in admission, reference range for adults is 5 to 40 U/L (units per liter)
Apolipoprotein B
Time frame: only in admission
Apolipoprotein B (ApoB) is the primary apolipoprotein and is the carrier for the following lipids: chylomicrons, low-density lipoprotein ( LDL), very low-density lipoprotein (VLDL), intermediate-density lipoprotein (IDL), and lipoprotein. Unit used in mg/dL
High-sensitivity c-reactive protein
Time frame: only in admission
High-sensitivity C-reactive protein (hsCRP) is a marker of inflammation that predicts incident myocardial infarction, stroke, peripheral arterial disease, and sudden cardiac death. Unit used in mg/L
PASI
Time frame: only in admission
A PASI (The Psoriasis Area and Severity Index) score can range from 0 to 72
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
- Background: PubMed 34181079Sholihah MM, Kusuma TRH, Hanif MI, Prabowo NA. Letter to the Editor on Type 1 diabetes onset triggered by COVID-19. Acta Diabetol. 2021 Sep;58(9):1283-1284. doi: 10.1007/s00592-021-01761-3. Epub 2021 Jun 28. No abstract available.
- Results publication: PubMed 34912736Pratama YS, Pradiptakirana R, Rachmah A, Prabowo NA. Autoimmune Thrombocytopenia in SLE and COVID-19. Eur J Case Rep Intern Med. 2021 Nov 3;8(11):002863. doi: 10.12890/2021_002863. eCollection 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis, run by Universitas Sebelas Maret at 1 site in Indonesia.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 13 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Gamma-Glutamyl Transferase (time frame: only in admission). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05943405, which also lists 2 linked publications.
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 13 Jul 2023; AzTrials last refreshed its copy on 4 Nov 2026.