- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06833164
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
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
-
-
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
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.