Gardasil Versus Cervarix in the Treatment of Warts

Study Overview
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Brief Summary
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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
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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

Official Title
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Quadrivalent and Bivalent Human Papilloma Virus Vaccines in the Treatment of Common Recalcitrant Warts

Conditions
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Verruca Viral

Intervention / Treatment
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* Drug: Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine
* Drug: Bivalent Human Papilloma Virus Vaccine
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Quadrivalent vaccine<br>Patient receive 0.1 ml of quadrivalent HPV vaccine intralesional every two weeks | Drug: Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine<br>* intralesional 0.1 ml every two weeks<br>|
| Experimental: Bivalent Vaccine<br>Patient received 0.1 ml of bivalent HPV vaccine intralesional once every two weeks | Drug: Bivalent Human Papilloma Virus Vaccine<br>* Intralesional 0.1 ml every two weeks<br>|
| Placebo Comparator: Saline control<br>Patient received 0.1 ml of intralesional saline once every two weeks | Drug: Saline<br>* intralesional into the largest warts every two weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Therapeutic response | The percentage of patients in each group achieving complete, partial or no response at the end of the treatment sessions | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety measure | Immediate adverse events recorded by the treating physician within 1 hour post injection | 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 | 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 | 6 months following the end of treatment sessions |