Cantharone for the Treatment of Perenial Warts

Study Overview
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Brief Summary
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Comparison of trichloroacetic acid versus cantharidine for the treatment of perenial warts.

Detailed Description
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Warts are one of the most common sexually transmitted diseases. They are caused by the human papilloma virus (HPV) that causes cervical cancer. Warts can grow, obstruct labor, and spread. Patients presenting to the obgyn clinic with perenial warts were randomized to treatment with trichloroacetic acid (one of the many types of treatments) or to the treatment with cantharidine group. Cantharidine is a vesicant extracted from beetle bugs which painlessly causes a small blister to form and cures the patient from the HPV infection causing the wart . We compared cosmesis, scar formation, pain and number of treatments (visits) as well as effectiveness in both groups. Objectives Determine if cantharone is more effective than trichloroacetic acid (TCA) for removal of warts Compare pain levels (pain during application) for each method Compare patient satisfaction for each method Compare scar formation and cosmesis for each method

Official Title
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Trichloroacetic Acid Versus Cantharone for the Treatment of Perenial Warts

Conditions
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Wart, Genital

Intervention / Treatment
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* Drug: Cantharidin
* Drug: Trichloroacetic Acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Warts on the perenial area Less than 4mm across. Exclusion Criteria: Pregnancy Less than 18 years old Lesions larger than 4 millimeters across Unclear diagnosis Internal warts Diabetes HIV Warts within 2 cm of mucosal areas

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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
Interventional Model Description: Patients will be randomized to receive either trichloroacetic acid or cantharidine treatment.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cantharidine group<br>Application of cantharidine to perenial warts | Drug: Cantharidin<br>* A thin film of cantharidin is applied to the surface of the wart and to 1 millimeter area surrounding the wart. After the film dries, it is covered with an occlusive dressing for 24 hours. The patient removes the area the next day and thoroughly washes the area with soap and water. Patients return to clinic a week later.<br>|
| Active Comparator: trichloroacetic acid group<br>application of trichloroacetic acid to perenial warts | Drug: Trichloroacetic Acid<br>* Trichloroacetic acid is applied to the surface of the wart with a wooden applicator and after drying the area is washed with soap and water in an hour.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain on treatment | Comparison of pain when treatment is applied. The patient is asked on a scale of 0-5 (with 5 being extreme pain, 4 being severe pain, 3 being moderate, 2 being mild, 1 being slight and zero being no pain, how do you rate your pain. | at 30 minutes time point from application of treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of a patient's likelihood of using this method again as measured on a survey question | A questionnaire given to the patient at the conclusion of the study and containing the question on a scale from 1-5 (5 most likely) how likely are you to recommend this method to a friend or using it again yourself. | 2 weeks from starting therapy | 
| Presence of scarring or skin discoloration | At the time of wart eradication, the treatment area is examined for healing. The clinician rates cosmesis on a scale from 0-5 with 5-skin grows back perfectly, 4-slight discoloration, 3-thickened skin, 1-slight scarring and 0-scarring. | 2 weeks from starting therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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warts, trichloroacetic acid