Clinical trial NCT03625960: Cantharone for the Treatment of Perenial Warts
Official title: Trichloroacetic Acid Versus Cantharone for the Treatment of Perenial Warts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Wart, Genital
Keywords: warts
trichloroacetic acid
Lead sponsor: Wayne State University
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
name: St Vincent's Hospital
First posted: 2018-08-10
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized to receive either trichloroacetic acid or cantharidine treatment.
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Pain on treatment
timeFrame: at 30 minutes time point from application of treatment.
Secondary outcomes:
measure: Assessment of a patient's likelihood of using this method again as measured on a survey question
timeFrame: 2 weeks from starting therapy
measure: Presence of scarring or skin discoloration
timeFrame: 2 weeks from starting therapy
Other outcomes:
Locations:
Study officials:
References:
citation: Bakardzhiev I, Kovachev E. [Comparative assessment of the methods of treatment of Condylomata acuminata]. Akush Ginekol (Sofiia). 2011;50(4):45-51. Bulgarian.
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.
citation: 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.
citation: 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.