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

Warts Hand Clinical Trial

Official title:

IL-4 and IFN-γ as Immunologic Predictors of Response to HPV Immunotherapy in Warts

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05100043
• Other study ID #: 3140-23-10-2019
• Status: Completed
• Start date: January 3, 2020
• Est. completion date: March 2, 2021

Study information

• Verified date: November 2023
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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

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 Blood samples were withdrawn then whole blood cultures are prepared.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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 2, 2021
• Est. primary completion date: July 3, 2020
• Gender: All
• Age group: 36 Months and older

Eligibility

Inclusion Criteria:

• Patients with recurrent and recalcitrant cutaneous and anogenital warts.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Condylomata Acuminata
• Wart, Genital
• Warts
• Warts Hand

Intervention

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Blood samples are withdrawn from participants and whole blood cultures are prepared and stimulated by bivalent HPV vaccine.IL-4 and IFN-?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

Locations

Country	Name	City	State
Egypt	Zagazig University Faculty of Medicine	Zagazig	Sharkia

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of IFN-? and IL-4 levels	Quantitative measurement of IFN-? and IL-4 in culture supernatants	48 hours
Secondary	Change in the size of warts	Clinical observation and photographing of wart size	6 months