Cantharone for the Treatment of Perenial Warts

Trichloroacetic Acid Versus Cantharone for the Treatment of Perenial Warts

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

Study Overview

• Status: Completed
• Conditions: Wart, Genital
• Intervention / Treatment: Drug: Cantharidin; Drug: Trichloroacetic Acid

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cantharidine group; Application of cantharidine to perenial warts	Drug: Cantharidin; 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.
Active Comparator: trichloroacetic acid group; application of trichloroacetic acid to perenial warts	Drug: Trichloroacetic Acid; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Wayne State University
• Collaborators: St Vincent's Hospital; University of California, San Francisco Fresno

Publications and helpful links

General Publications

• Bakardzhiev I, Kovachev E. [Comparative assessment of the methods of treatment of Condylomata acuminata]. Akush Ginekol (Sofiia). 2011;50(4):45-51. Bulgarian.
• Kollipara R, Ekhlassi E, Downing C, Guidry J, Lee M, Tyring SK. Advancements in Pharmacotherapy for Noncancerous Manifestations of HPV. J Clin Med. 2015 Apr 24;4(5):832-46. doi: 10.3390/jcm4050832.
• EPSTEIN WL, KLIGMAN AM. Treatment of warts with cantharidin. AMA Arch Derm. 1958 May;77(5):508-11. doi: 10.1001/archderm.1958.01560050014003. No abstract available.
• Ramirez-Fort MK, Au SC, Javed SA, Loo DS. Management of cutaneous human papillomavirus infection: pharmacotherapies. Curr Probl Dermatol. 2014;45:175-85. doi: 10.1159/000356069. Epub 2014 Mar 13.

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2006
• Primary Completion (Actual): June 15, 2007
• Study Completion (Actual): July 15, 2007

Study Registration Dates

• First Submitted: August 2, 2018
• First Submitted That Met QC Criteria: August 7, 2018
• First Posted (Actual): August 10, 2018

Study Record Updates

• Last Update Posted (Actual): August 10, 2018
• Last Update Submitted That Met QC Criteria: August 7, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: trichloroacetic acid; warts
• Additional Relevant MeSH Terms: Skin Diseases; Virus Diseases; Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; DNA Virus Infections; Skin Diseases, Infectious; Papillomavirus Infections; Skin Diseases, Viral; Tumor Virus Infections; Warts; Condylomata Acuminata; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Cantharidin
• Other Study ID Numbers: 01551

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No