ClinicalTrials.gg
CompletedNCT05100043Updated Feb 19, 2025

Interleukin 4 and Interferon Gamma Predictors of Human Papillomavirus Immunotherapy in Warts

An observational study in Warts Hand and Wart, Genital, sponsored by Zagazig University. Completed at 1 site in Egypt. Open to participants aged 36 Months and older. Per ClinicalTrials.gov, last updated 2025-02-19.

Sponsored by Zagazig University · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
80
Ages
36 Months and older
Sex
All
01

Study summary

In the present study the investigators assessed the invitro role of IL-4 and IFN-γ in predicting the response to bivalent HPV vaccine after whole blood stimulation

Read the detailed description

40 Patients and 40 controls are enrolled in the study. Participants suffer from chronic recurrent cutaneous and genital warts. Blood samples were withdrawn then whole blood cultures are prepared. Cultures are stimulated with bivalent HPVvaccine. IL-4 and IFN-γ measurement in culture supernatants by ELISA. IL-4 and IFN-γ are investigated to predict the therapeutic response to bivalent HPV vaccine immunotherapy in warts.

02

Conditions studied

  • Warts Hand
  • Wart, Genital

Browse trials for

03

In context

Condylomata Acuminata

116 studies on the registry are indexed under Condylomata Acuminata; 11 are open to participants now.

This study's enrollment of 80 is below the median of 316 across 20 observational studies indexed under Condylomata Acuminata.

Browse Condylomata Acuminata studies →

Lead sponsor

Zagazig University is the lead sponsor of 459 studies on the registry; 77 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
36 Months and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients are attendants in Zagazig University Hospitals Dermatology outpatient clinic

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with recurrent and recalcitrant cutaneous and anogenital warts.

Exclusion criteria

Exclusion Criteria:

  • History of allergy to the HPV vaccine
  • Active viral, fungal, or bacterial infections
  • diseases or drugs.
  • diseases, or other systemic diseases, e.g., hepatic, or renal disorders, diabetes, meningitis or convulsions
  • Skin allergies
  • Pregnancy and lactation
  • Earlier wart treatment at least one month before enrollment.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
80 participants (actual)
Patient registry
No

Groups and cohorts

  • Cases

    Patients having multiple recurrent and recalcitrant cutaneous and genital warts

    Biological: IL-4 and IFN-γ measurements

  • Controls

    Healthy volunteers matched for age and sex

    Biological: IL-4 and IFN-γ measurements

Interventions

  • BiologicalIL-4 and IFN-γ measurements

    Blood samples are withdrawn from participants and whole blood cultures are prepared and stimulated by bivalent HPV vaccine.IL-4 and IFN-γ are measured in culture supernatants

06

What researchers measure

Primary outcomes

  1. Change of IFN-γ and IL-4 levels

    Quantitative measurement of IFN-γ and IL-4 in culture supernatants

    Time frame: 48 hours

Secondary outcomes

  1. Change in the size of warts

    Clinical observation and photographing of wart size

    Time frame: 6 months

07

Study locations

1 site
  • Zagazig University Faculty of Medicine
    Zagazig, Sharkia 44519, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05100043
Lead sponsor
Zagazig University
Responsible party
Noha M Hammad, MD (Principal investigator, Zagazig University) — Principal investigator
First posted
Oct 29, 2021
Start date
Jan 3, 2020
Primary completion
Jul 3, 2020
Completion
Mar 2, 2021
Last update
Feb 19, 2025

Study contacts

Ayman Marei, MD, PhD
study director · Faculty of Medicine, Zagazig University , Zagazig, Egypt

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion