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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

Tracking Information
First Submitted Date  ICMJE August 2, 2018
First Posted Date  ICMJE August 10, 2018
Last Update Posted Date August 10, 2018
Actual Study Start Date  ICMJE June 15, 2006
Actual Primary Completion Date June 15, 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2018)
  • 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".
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cantharone for the Treatment of Perenial Warts
Official Title  ICMJE Trichloroacetic Acid Versus Cantharone for the Treatment of Perenial Warts
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE 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
Condition  ICMJE Wart, Genital
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: Cantharidine group
    Application of cantharidine to perenial warts
    Intervention: Drug: Cantharidin
  • Active Comparator: trichloroacetic acid group
    application of trichloroacetic acid to perenial warts
    Intervention: Drug: Trichloroacetic Acid
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 7, 2018)
12
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 15, 2007
Actual Primary Completion Date June 15, 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
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.
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03625960
Other Study ID Numbers  ICMJE 01551
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Maurice-Andre Recanati, Wayne State University
Study Sponsor  ICMJE Wayne State University
Collaborators  ICMJE
  • University of California, San Francisco Fresno
  • St. Vincents Hospital Manhattan
Investigators  ICMJE Not Provided
PRS Account Wayne State University
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP