NCT05943405

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 13, 2023

Completed
Last Updated

July 13, 2023

Status Verified

July 1, 2023

Enrollment Period

7 months

First QC Date

June 25, 2023

Last Update Submit

July 4, 2023

Conditions

Keywords

PsoriasisPsoriasis Area and Severity IndexGamma-Glutamyl TransferaseCRPApolipoprotein B

Outcome Measures

Primary Outcomes (4)

  • Gamma-Glutamyl Transferase

    Gamma-Glutamyl Transferase was check in admission, reference range for adults is 5 to 40 U/L (units per liter)

    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

    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

    only in admission

  • PASI

    A PASI (The Psoriasis Area and Severity Index) score can range from 0 to 72

    only in admission

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Psoriasis Patients

You may qualify if:

  • Clinical diagnosis of Psoriasis

You may not qualify if:

  • Heart Failure
  • Diabetes Mellitus
  • Kidney Disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitas Sebelas Maret Hospital

Sukoharjo, Central Java, 57161, Indonesia

Location

Related Publications (2)

  • 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.

    PMID: 34181079BACKGROUND
  • Pratama 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.

Biospecimen

Retention: NONE RETAINED

5 cc of blood was drawn for GGT, hs-CRP, and apo B examinations.

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Hospital Research Unit

Study Record Dates

First Submitted

June 25, 2023

First Posted

July 13, 2023

Study Start

June 1, 2022

Primary Completion

December 30, 2022

Study Completion

December 30, 2022

Last Updated

July 13, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations