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Cantharone for the Treatment of Perenial Warts

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ClinicalTrials.gov Identifier: NCT03625960
Recruitment Status : Completed
First Posted : August 10, 2018
Last Update Posted : August 10, 2018
Sponsor:
Collaborators:
University of California, San Francisco Fresno
St. Vincents Hospital Manhattan
Information provided by (Responsible Party):
Maurice-Andre Recanati, Wayne State University

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

Condition or disease Intervention/treatment Phase
Wart, Genital Drug: Cantharidin Drug: Trichloroacetic Acid Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients will be randomized to receive either trichloroacetic acid or cantharidine treatment.
Masking: Single (Investigator)
Masking Description: Patients will be randomized to receive treatment with trichloroacetic acid or cantharidine.
Primary Purpose: Treatment
Official Title: Trichloroacetic Acid Versus Cantharone for the Treatment of Perenial Warts
Actual Study Start Date : June 15, 2006
Actual Primary Completion Date : June 15, 2007
Actual Study Completion Date : July 15, 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Warts

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Pain on treatment [ Time Frame: 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 :
  1. Assessment of a patient's likelihood of using this method again as measured on a survey question [ Time Frame: 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".

  2. Presence of scarring or skin discoloration [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   This is a study on perenial genital warts, near the vulvovaginal area. Only women have vulvovaginas.
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Maurice-Andre Recanati, Assistant Professor, Clinical Educator, Wayne State University
ClinicalTrials.gov Identifier: NCT03625960    
Other Study ID Numbers: 01551
First Posted: August 10, 2018    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Maurice-Andre Recanati, Wayne State University:
warts
trichloroacetic acid
Additional relevant MeSH terms:
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Warts
Condylomata Acuminata
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Tumor Virus Infections
 Skin Diseases, Infectious
Skin Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Cantharidin
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action