Intralesional Measles, Mumps, Rubella (MMR) Vaccine Versus Cryotherapy in Treatment of Multiple Common and Planter Warts

Study Overview
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Brief Summary
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Warts are benign epidermal tumors caused by human papilloma virus, which are epitheliotropic non-enveloped double stranded DNA viruses. Transmission of warts occurs from direct person-to-person contact or indirectly by fomites . Warts appear in various forms including verruca vulgaris, plane, plantar, filiform, digitate and periungual.

Detailed Description
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Treatment of warts is difficult for patients and physicians . Currently Available treatment options include cryosurgery, laser, electrosurgery, bleomycin, and topical keratolytic applications; many of them are painful, ineffective, costly and prone for recurrences. Cryotherapy, which uses liquid nitrogen to freeze tissues and destroy warts, is one of the most common and effective treatments. freezing causes local irritation, leading the host to mount an immune reaction against the virus. Immunotherapy appears to enhance virus recognition by immune system; allowing clearance of treated wart, distant warts , and helps to prevent infection .Recently, intralesional immunotherapy using different antigens such as mumps, Candida, and tuberculin has been proved effective in the treatment of warts. The exact mechanism of action of intralesional immunotherapy is still obscure. Intralesional antigen injection probably induces strong non specific inflammatory response against the human papilloma virus-infected cells. It has been suggested that intralesional measles mumps rubella vaccine results in regression of warts via induction of immune system.

Official Title
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Intralesional Measles, Mumps, Rubella (MMR) Vaccine Versus Cryotherapy in Treatment of Multiple Common and Planter Warts : a Randomized Controlled Trial

Conditions
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Plantar Wart, Common Wart

Intervention / Treatment
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* Drug: Measles-Mumps-Rubella Vaccine
* Procedure: cryotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients should have multiple common or plantar warts. No concurrent systemic or topical treatment of warts Exclusion Criteria: patients under 16 years old. • Patients with fever or signs of any inflammation or infection. Patients with other types of warts. Patients with single warts. Pregnancy. Lactation. Immunosuppression. Patients who received any other treatments for their warts in the month before starting study. Past history of asthma, allergic skin disorders, meningitis or convulsions.

Ages Eligible for Study
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Minimum Age: 16 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MMR vaccine<br>Measles-Mumps-Rubella Vaccine will be injected 0.5 ml into the largest wart at 2-week intervals until complete clearance was achieved or for a maximum of 3 treatments | Drug: Measles-Mumps-Rubella Vaccine<br>* MMR vaccine will be injected 0.5 ml into the largest wart at 2-week intervals until complete clearance was achieved or for a maximum of 3 treatments. Response to treatment will be evaluated 1 month after the last session by decrease in the size of warts, decrease in the number of warts and photographic comparison. The clinical response was graded into complete (complete cure), partial (if there was a decrease in the size and\or a decrease in the total number of warts), and no response (no change in size and number of warts).<br>* Other names: MMR;|
| Active Comparator: Cryotherapy<br>patients received cryotherapy with liquid nitrogen once every 2 weeks until complete clearance or for a maximum of 3 sessions | Procedure: cryotherapy<br>* patients received cryotherapy with liquid nitrogen once every 2 weeks until complete clearance or for a maximum of 3 sessions.Response to treatment will be evaluated 1 month after the last session by decrease in the size of warts, decrease in the number of warts and photographic comparison. The clinical response was graded into complete (complete cure), partial (if there was a decrease in the size and\or a decrease in the total number of warts), and no response (no change in size and number of warts).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cure rate | Assess cure rate of MMR vaccine and cryotherapy in treatment of common and planter warts (complete disappearance of lesions) one month after last session, compare efficacy of both measures. | 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of partial response to both measures | if there was a decrease in the size or a decrease in the total number of warts | 60 days | 
| Side effects | Detection of post procedure side effects such as flu like symptoms, pain , hypopigmentation. | 60 days |