Comparison Between Tuberculin Vaccine and Cryotherapy in Genital Wart Patients

Study Overview
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Brief Summary
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Cutaneous and genital warts are common dermatological conditions caused by Human Papilloma Virus. Although it is a benign condition it causes disfigurement, has tendency to collect, can be transmitted to others, this makes adequate and timely treatment important, while many warts are resolve spontaneously over several years, most patients seek treatment because the warts are unsightly and often tender or painful.

Detailed Description
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Genital warts are highly contagious sexually transmitted diseases (STD) caused by infection of Human Papilloma Virus and, as the most common STD in developed countries, can currently be considered to be globally epidemic. It is estimated that the frequency of Human Papilloma Virus infection among women in the world ranges from 2% to 44%. The conventional modalities in treatment of warts include destructive therapies such as salicylic acid, trichloroacetic acid, cryotherapy, silver nitrate, phenol, cantharidin, surgical interventions and laser, antiproliferative agents such as bleomycin, vitamin D analogs, podophyllin, 5 fluorouracil and antiviral agents such as cidofovir and retinoids. There are different mechanisms have been proposed for the resolution of warts with skin test antigens such as mumps, candida, trichophyton both at the injected as well as distant sites. Tuberculin: Purified protein derivative or tuberculin stimulates the cell mediated immunity non specifically by activating T helper 1 cells, Natural Killer cells, and cytokine production an increase in interleukin-12 as a process in boosting the cell-mediated immunity contributes to the mechanism of action.

Official Title
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Comparison Between Tuberculin Vaccine and Cryotherapy in the Treatment of Genital Wart Patients

Conditions
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Genital Wart

Intervention / Treatment
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* Biological: tuberculin
* Device: cryotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All types of genital and anal warts will be included in this study especially patients with 5 or more warts and more than 1 cm in size Exclusion Criteria: Patients with immunodeficient diseases or receiving any immunosuppressive drugs Pregnancy and lactation

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 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: study group<br>include (15) patients will be injected with Tuberculin vaccine 0.3 ml every 2 weeks, vaccine will be injected in the largest wart, 4 sessions will be done then patients will be followed for 2 months | Biological: tuberculin<br>* inject the mother wart with .3 ml tuberculin vaccine every 2 weeks<br>|
| Active Comparator: control group<br>include (15) patients will be treated with cryotherapy every 2 weeks ,4 sessions will be done then patients will be followed for 2 months | Device: cryotherapy<br>* 10 sec 1 cycle into all genital warts<br>|
| Experimental: combined group<br>include (15) patients will be treated with combined cryotherapy and Tuberculin vaccine , one week cryotherapy and the other week Tuberculin vaccine , then patients will be followed for 2 weeks | Biological: tuberculin<br>* inject the mother wart with .3 ml tuberculin vaccine every 2 weeks<br>Device: cryotherapy<br>* 10 sec 1 cycle into all genital warts<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients with complete resolution of genital warts | frequency (number) | 4 months |