Cantharone for the Treatment of Perenial Warts

Wart, Genital Clinical Trial

Official title:

Trichloroacetic Acid Versus Cantharone for the Treatment of Perenial Warts

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03625960
• Other study ID #: 01551
• Status: Completed
• Phase: Phase 4
• Start date: June 15, 2006
• Est. completion date: July 15, 2007

Study information

• Verified date: August 2018
• Source: Wayne State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 15, 2007
• Est. primary completion date: June 15, 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Condylomata Acuminata
• Wart, Genital
• Warts

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Wayne State University	St. Vincents Hospital Manhattan, University of California, San Francisco Fresno

References & Publications (4)

Bakardzhiev I, Kovachev E. [Comparative assessment of the methods of treatment of Condylomata acuminata]. Akush Ginekol (Sofiia). 2011;50(4):45-51. Review. Bulgarian. — View Citation

EPSTEIN WL, KLIGMAN AM. Treatment of warts with cantharidin. AMA Arch Derm. 1958 May;77(5):508-11. — View Citation

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. Review. — View Citation

Ramírez-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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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