Gardasil Versus Cervarix in the Treatment of Warts

Zagazig University50 enrolled

Overview

Warts are common, benign, epidermal proliferations caused by HPV infecting skin and mucous membranes. Treatment of warts poses a true challenge despite existing variable therapeutic modalities, whether destructive or immunotherapeutic. Human papilloma virus (HPV) vaccines are FDA approved for the prevention of genital warts and wart related precancerous and cancerous lesions but they are not indicated for treatment of preexisting warts yet

Approximately 35% of viral warts tend to be recalcitrant either showing no response to treatment or having prompt recurrences after treatment, causing frustration for both patients and physicians. Success rates vary significantly across patients and across different therapeutic interventions ranging from 7% to 90%. Immunotherapy is proposed to enhance virus recognition by the cell mediated immunity, which allows the clearance of both treated and untreated warts and helps to prevent recurrences through induction of a long-term acquired immunity to HPV. Few reports suggest the possibility of using quadrivalent or bivalent HPV vaccines as therapeutic modality rather than only preventive modality. This is a randomized controlled study to assess the efficacy and safety of quadrivalent and bivalent HPV vaccines in the treatment of warts

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Verruca Viral

Interventions

Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant VaccineDRUG

intralesional 0.1 ml every two weeks

Bivalent Human Papilloma Virus VaccineDRUG

Intralesional 0.1 ml every two weeks

SalineDRUG

intralesional into the largest warts every two weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult Patients with recalcitrant multiple warts of any type. Warts were considered recalcitrant if they persisted for at least 6 months without any response to 2 different therapeutic modalities or more. * Immunocompetent patients. * Patients who do not receive any treatment of warts for at least 1 month before the start of study. * Patients who are able to understand and follow the study protocol and approve to sign the informed consent Exclusion Criteria: * Patients with acute febrile illness. * Past history of asthma. * Allergic skin disorders, such as generalized eczema, or severe urticaria. * Pregnancy or lactation * History of hypersensitivity to the treatment vaccines. * Children * Immunocompromised patients * Patients unable to follow the study protocol

Locations (1)

Dermatology department, Zagazig University Hospitals, Faculty of Medicine, Zagazig University

Zagazig, Select Region, Egypt

Outcomes

Primary Outcomes

Therapeutic response

The percentage of patients in each group achieving complete, partial or no response at the end of the treatment sessions

Time frame: Through study completion for a maximum of 12 weeks, evaluation held at two weeks interval and at the end of treatment sessions (12th week visit)

Secondary Outcomes

Safety measure

Immediate adverse events recorded by the treating physician within 1 hour post injection

Time frame: Through study completion every treatment session held at two weeks interval for a maximum of 5 sessions

Safety measure

Delayed adverse events reported by the patients in between sessions

Time frame: Through study completion for a maximum of 12 weeks held every two weeks till the end of the treatment sessions (12th week visit)

Recurrence

Percentage of patients experiencing recurrences in each group

Time frame: 6 months following the end of treatment sessions

Data from ClinicalTrials.gov

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