Warts HandNCT05100043
Interleukin 4 and Interferon Gamma Predictors of Human Papillomavirus Immunotherapy in Warts
An observational study of Warts Hand and Wart, Genital, run by Zagazig University at 1 site in Egypt.
Trial 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 more about this study
- Who is it for?
- Ages 36 months and older
- Conditions the study is for
- Warts Hand, Wart, Genital
- What is being tested?
- IL-4 and IFN-γ measurements
- Type of treatment
- Vaccines
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Jan 2020to 2 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 36 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients are attendants in Zagazig University Hospitals Dermatology outpatient clinic
Who may be able to join
- Patients with recurrent and recalcitrant cutaneous and anogenital warts.
Who cannot join
- History of allergy to the HPV vaccine
- Active viral, fungal, or bacterial infections
- Immunosuppressive diseases or drugs.
- Autoimmune 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Zagazig University Faculty of Medicine
Zagazig, Sharqia Province, 44519
About this study
Official title: IL-4 and IFN-γ As Immunologic Predictors of Response to HPV Immunotherapy in Warts
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 Blood samples were withdrawn then whole blood cultures are prepared.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.
- Conditions
- Warts Hand, Wart, Genital
- Being tested
- IL-4 and IFN-γ measurements
- Medical subject headings
- Condylomata Acuminata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IL-4 and IFN-γ measurementsBiological
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
| Study group | Role | What they receive |
|---|---|---|
| Cases | Patients having multiple recurrent and recalcitrant cutaneous and genital warts Receives: Biological: IL-4 and IFN-γ measurements | |
| Controls | Healthy volunteers matched for age and sex Receives: Biological: IL-4 and IFN-γ measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of IFN-γ and IL-4 levels
Quantitative measurement of IFN-γ and IL-4 in culture supernatants
Measured: 48 hours
Secondary outcomes (1)
Change in the size of warts
Clinical observation and photographing of wart size
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start3 Jan 2020
- Primary completion3 Jul 2020
- Study completion2 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Warts HandStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Noha M Hammad, MD, Zagazig University
- Investigators
- Ayman Marei, MD, PhD, Study director, Faculty of Medicine, Zagazig University , Zagazig, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05100043
- Sponsor's protocol ID
- 3140-23-10-2019
- Status last verified
- Feb 2025
- First submitted
- 5 Oct 2021
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IL-4 and IFN-γ As Immunologic Predictors of Response to HPV Immunotherapy in Warts
- ClinicalTrials.gov ID
- NCT05100043
- Acronym / sponsor ID
- 3140-23-10-2019
- Conditions
- Warts Hand, Wart, Genital
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 3 Jan 2020 (actual)
- Primary completion
- 3 Jul 2020 (actual)
- Study completion
- 2 Mar 2021 (actual)
- First posted
- 29 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Biological: IL-4 and IFN-γ measurementsPatients having multiple recurrent and recalcitrant cutaneous and genital warts |
| Controls | – | Biological: IL-4 and IFN-γ measurementsHealthy volunteers matched for age and sex |
Who may qualify
- Ages
- 36 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients are attendants in Zagazig University Hospitals Dermatology outpatient clinic
Key inclusion criteria (1 listed)
- Patients with recurrent and recalcitrant cutaneous and anogenital warts.
Key exclusion criteria (7 listed)
- History of allergy to the HPV vaccine
- Active viral, fungal, or bacterial infections
- Immunosuppressive diseases or drugs.
- Autoimmune diseases, or other systemic diseases, e.g., hepatic, or renal disorders, diabetes, meningitis or convulsions
- Skin allergies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IL-4 and IFN-γ measurementsBlood 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 | Biological | Cases, Controls |
Primary outcome
Change of IFN-γ and IL-4 levels
Time frame: 48 hours
Quantitative measurement of IFN-γ and IL-4 in culture supernatants
1 secondary outcome
Change in the size of warts
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayman Marei, MD, PhD study director
Faculty of Medicine, Zagazig University , Zagazig, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Warts Hand and Wart, Genital, run by Zagazig University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of IFN-γ and IL-4 levels (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.