NCT06833164

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2022

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2024

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 13, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 18, 2025

Completed
Last Updated

February 18, 2025

Status Verified

February 1, 2025

Enrollment Period

1.5 years

First QC Date

February 13, 2025

Last Update Submit

February 17, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • SERUM LEVELS OF endoplasmic reticulum aminopeptidase 1 and 2

    using specific Commercial human ELISA kits

    ONE YEAR

Interventions

endoplasmic reticulum aminopeptidase1 and 2 serum levels determination via ELISA

endoplasmic reticulum aminopeptidase 1 and 2 serum levels determination via ELISA

Also known as: SEUM ERAP1 MEASUREMENT USING ELISA, SERUM ERAP2MEASUREMENT USING ELISA

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of medicine Benha University

Banhā, Qalyubia Governorate, 13511, Egypt

Location

MeSH Terms

Conditions

Warts

Condition Hierarchy (Ancestors)

Papillomavirus InfectionsDNA Virus InfectionsVirus DiseasesInfectionsSkin Diseases, ViralTumor Virus InfectionsSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Ihab Y. Abdallah, MD

    Professor of Dermatology, Venereology and Andrology, Faculty of Medicine, Benha University

    STUDY CHAIR
  • Nehad A.Fouad, MD

    Professor of Microbiology and Immunology, Faculty of Medicine, Benha University

    STUDY DIRECTOR
  • Ola S Ebrahim, MBBCh

    Benha University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor of dermatology, venereology and andrology

Study Record Dates

First Submitted

February 13, 2025

First Posted

February 18, 2025

Study Start

October 1, 2022

Primary Completion

March 20, 2024

Study Completion

March 20, 2024

Last Updated

February 18, 2025

Record last verified: 2025-02

Locations