Cantharone for the Treatment of Perenial Warts

Phase 4

Completed

• Conditions: Wart, Genital
• Interventions: Drug: Trichloroacetic Acid; Drug: Cantharidin

• Registration Number: NCT03625960
• Lead Sponsor: Wayne State University

Brief Summary

Comparison of trichloroacetic acid versus cantharidine for the treatment of perenial warts.

Detailed Description

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

1. Determine if cantharone is more effective than trichloroacetic acid (TCA) for removal of warts

2. Compare pain levels (pain during application) for each method

3. Compare patient satisfaction for each method

4. Compare scar formation and cosmesis for each method

Study Timeline

• Study Start: 2006-06-15
• Primary Completion: 2007-06-15
• Study Completion: 2007-07-15
• Status Verified: 2018-08
• Study First Submitted: 2018-08-02
• Study First Submitted QC: 2018-08-07
• Last Update Submitted: 2018-08-07
• Study First Posted: 2018-08-10
• Last Update Posted: 2018-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
trichloroacetic acid group	Trichloroacetic Acid	application of trichloroacetic acid to perenial warts
Cantharidine group	Cantharidin	Application of cantharidine to perenial warts

Primary Outcome Measures

Name	Time	Method
Pain on treatment	at 30 minutes time point from application of 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.

Secondary Outcome Measures

Name	Time	Method
Assessment of a patient's likelihood of using this method again as measured on a survey question	2 weeks from starting therapy	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".
Presence of scarring or skin discoloration	2 weeks from starting therapy	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.