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

NCT05100043 | Completed

• 1 other identifier: 3140-23-10-2019
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Warts Hand; Wart, Genital

Outcome Measures

Primary Outcomes (1)

• Change of IFN-γ and IL-4 levels

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

  48 hours

Secondary Outcomes (1)

• Change in the size of warts

  6 months

Study Arms (2)

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

IL-4 and IFN-γ measurements BIOLOGICAL

Blood samples are withdrawn from participants and whole blood cultures are prepared and stimulated by bivalent HPV vaccine.IL-4 and IFN-γ are measured in culture supernatants

Cases; Controls

Eligibility Criteria

• Age: 36 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients are attendants in Zagazig University Hospitals Dermatology outpatient clinic

You may qualify if:

• Patients with recurrent and recalcitrant cutaneous and anogenital warts.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig University Faculty of Medicine

Zagazig, Sharqia Province, 44519, Egypt

Location

MeSH Terms

Conditions

Condylomata Acuminata

Interventions

Interleukin-4

Condition Hierarchy (Ancestors)

Papillomavirus Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Warts; Skin Diseases, Viral; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Ayman Marei, MD, PhD

  Faculty of Medicine, Zagazig University , Zagazig, Egypt

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 5, 2021
• First Posted: October 29, 2021
• Study Start: January 3, 2020
• Primary Completion: July 3, 2020
• Study Completion: March 2, 2021
• Last Updated: February 19, 2025

Record last verified: 2025-02

Locations

EG (1)