ERAP1,2 in Recalcitrant Warts

February 17, 2025 updated by: karem Taha ibrahim khalil, Benha University

Serum ERAP1 and ERAP2 Levels in Patients with Recalcitrant Warts

The exact mechanisms underlying the contribution of cellular immunity in the eradication of human papillomavirus (HPV) infections remain obscure. Individuals who have treatment-resistant warts frequently have immune deficiencies. Amino-peptidases (ERAP1, ERAP2) of endoplasmic reticulum are essential for production of antigenic epitopes that attach to the Major Histocompatibility Complex (MHC) class I and activate T-lymphocytes or natural killer (NK) cells. Aim: To assess ERAP1 and ERAP2 serum concentrations in patients with resistant warts.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Qalubia
      • Benha, Qalubia, Egypt, 13511
        • Faculty of Medicine Benha University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Two hundred individuals were separated into two groups. Group (I) patients with resistant warts (n=100), and group (II) age- and sex-matched subjects with history of treated warts with no recurrence (n=100). They were recruited from the Dermatology Outpatient Clinic at Benha University Hospitals

Description

Inclusion Criteria:

• Patients who had a history of incomplete clearance or recurrence following two or more electrocautery sessions and four or more cryocautery treatments and intralesional bleomycin.

Exclusion Criteria:

  • Patients with genital warts
  • Patients on systemic steroids or other immunosuppressive treatments
  • Immunocompromised individuals
  • Patients suffering from chronic systemic diseases
  • Pregnant women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SERUM LEVELS OF endoplasmic reticulum aminopeptidase 1 and 2
Time Frame: ONE YEAR
using specific Commercial human ELISA kits
ONE YEAR

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benha University

Investigators

  • Study Chair: Ihab Y. Abdallah, MD, Professor of Dermatology, Venereology and Andrology, Faculty of Medicine, Benha University
  • Study Director: Nehad A.Fouad, MD, Professor of Microbiology and Immunology, Faculty of Medicine, Benha University
  • Principal Investigator: Ola S Ebrahim, MBBCh, Benha Faculty of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Actual)

March 20, 2024

Study Completion (Actual)

March 20, 2024

Study Registration Dates

First Submitted

February 13, 2025

First Submitted That Met QC Criteria

February 17, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 17, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Serum ERAP1 and 2 in warts

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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