Gardasil Versus Cervarix in the Treatment of Warts
- Conditions
- Verruca Viral
- Interventions
- Drug: Bivalent Human Papilloma Virus VaccineDrug: SalineDrug: Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine
- Registration Number
- NCT05383625
- Lead Sponsor
- Zagazig University
- Brief Summary
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
- Detailed Description
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
-
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.
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Immunocompetent patients.
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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
-
Patients with acute febrile illness.
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Past history of asthma.
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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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bivalent Vaccine Bivalent Human Papilloma Virus Vaccine Patient received 0.1 ml of bivalent HPV vaccine intralesional once every two weeks Saline control Saline Patient received 0.1 ml of intralesional saline once every two weeks Quadrivalent vaccine Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine Patient receive 0.1 ml of quadrivalent HPV vaccine intralesional every two weeks
- Primary Outcome Measures
Name Time Method Therapeutic response 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) The percentage of patients in each group achieving complete, partial or no response at the end of the treatment sessions
- Secondary Outcome Measures
Name Time Method Recurrence 6 months following the end of treatment sessions Percentage of patients experiencing recurrences in each group
Safety measure Through study completion for a maximum of 12 weeks held every two weeks till the end of the treatment sessions (12th week visit) Delayed adverse events reported by the patients in between sessions
Trial Locations
- Locations (1)
Dermatology department, Zagazig University Hospitals, Faculty of Medicine, Zagazig University
🇪🇬Zagazig, Select Region, Egypt