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Completed

NCT Number: NCT03625960

Cantharone for the Treatment of Perenial Warts

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

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Key information

Conditions

Wart, Genital Communicable Diseases Condylomata Acuminata DNA Virus Infections Disease Attributes Genital Diseases Infections Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Skin Diseases Skin Diseases, Infectious Skin Diseases, Viral Skin and Connective Tissue Diseases Tumor Virus Infections Urogenital Diseases Virus Diseases Warts

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

About this study

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

  • Determine if cantharone is more effective than trichloroacetic acid (TCA) for removal of warts
  • Compare pain levels (pain during application) for each method
  • Compare patient satisfaction for each method
  • Compare scar formation and cosmesis for each method

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cantharidin

Drug

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

Drug

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Wayne State University

Other

Collaborators

  • St Vincent's Hospital
  • University of California, San Francisco

Registry information

Official study title

Trichloroacetic Acid Versus Cantharone for the Treatment of Perenial Warts

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Aug 10, 2018
Registry last updated
Aug 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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