Human Papilloma Virus Genotypes and Treatment Outcomes of Intralesional Immunotherapy of Anogenital Warts

NCT05761002 | Unknown DMC

• 1 other identifier: 94412022
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate the relationship between HPV genotypes and treatment outcomes of intralesional immunotherapy of anogenital warts with the quadrivalent vaccine (Gardasil).

Conditions

Human Papilloma Virus; Anogenital Wart

Outcome Measures

Primary Outcomes (1)

• improvement of lesion

  The response will be considered complete if there is disappearance of the warts, partial if the warts regressed in size by 50-99% and no response if there is 0-49% decrease in wart size.

  6 month

Study Arms (1)

treatment group

EXPERIMENTAL

All patients will be subjected to: * A thorough history taking and proper dermatological examination. * Skin sampling from anogenital wart lesions: skin sterilization followed by injection of local anesthesia at the base of lesions, then the part of wart above skin surface will be removed using shave biopsy technique. * DNA extraction of skin samples. * Conventional PCR for low-risk HPV genotypes (6,11) and RT-PCR for high-risk HPV genotypes. * Intralesional injection of the quadrivalent HPV vaccine (Gardasil) at a dose of 0.5ml, into the largest wart at 4-week intervals until complete clearance is achieved or for a maximum of three sessions.

Biological: the Quadrivalent Vaccine (Gardasil)

Interventions

the Quadrivalent Vaccine (Gardasil) BIOLOGICAL

• Intralesional injection of the quadrivalent HPV vaccine (Gardasil) at a dose of 0.5ml, into the largest wart at 4-week intervals until complete clearance is achieved or for a maximum of three sessions.

treatment group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- Patients with clinically diagnosed multiple anogenital warts who had not received treatment in the last 2 months before the study

You may not qualify if:

• Patient refusal, pregnancy, lactation, age less than 10 years, and immunosuppressive conditions

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Rana Ehab

Zagazig, 44519, Egypt

RECRUITING

MeSH Terms

Conditions

Condylomata Acuminata

Interventions

Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18

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)

Vaccines, Combined; Vaccines; Biological Products; Complex Mixtures; Papillomavirus Vaccines; Viral Vaccines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of dermatology

Study Record Dates

• First Submitted: February 26, 2023
• First Posted: March 9, 2023
• Study Start: June 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: July 1, 2023
• Last Updated: March 9, 2023

Record last verified: 2023-02

Locations

EG (1)