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Cantharone for the Treatment of Perenial Warts

Primary Purpose

Wart, Genital

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Cantharidin
Trichloroacetic Acid
Sponsored by
Wayne State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wart, Genital focused on measuring warts, trichloroacetic acid

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Cantharidine group

    trichloroacetic acid group

    Arm Description

    Application of cantharidine to perenial warts

    application of trichloroacetic acid to perenial warts

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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".
    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.

    Full Information

    First Posted
    August 2, 2018
    Last Updated
    August 7, 2018
    Sponsor
    Wayne State University
    Collaborators
    University of California, San Francisco, St Vincent's Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03625960
    Brief Title
    Cantharone for the Treatment of Perenial Warts
    Official Title
    Trichloroacetic Acid Versus Cantharone for the Treatment of Perenial Warts
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    June 15, 2006 (Actual)
    Primary Completion Date
    June 15, 2007 (Actual)
    Study Completion Date
    July 15, 2007 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Wayne State University
    Collaborators
    University of California, San Francisco, St Vincent's Hospital

    4. Oversight

    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
    Data Monitoring Committee
    No

    5. Study Description

    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 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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Wart, Genital
    Keywords
    warts, trichloroacetic acid

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Model Description
    Patients will be randomized to receive either trichloroacetic acid or cantharidine treatment.
    Masking
    Investigator
    Masking Description
    Patients will be randomized to receive treatment with trichloroacetic acid or cantharidine.
    Allocation
    Randomized
    Enrollment
    12 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Cantharidine group
    Arm Type
    Experimental
    Arm Description
    Application of cantharidine to perenial warts
    Arm Title
    trichloroacetic acid group
    Arm Type
    Active Comparator
    Arm Description
    application of trichloroacetic acid to perenial warts
    Intervention Type
    Drug
    Intervention Name(s)
    Cantharidin
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Trichloroacetic Acid
    Intervention Description
    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 Outcome Measure Information:
    Title
    Pain on treatment
    Description
    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.
    Time Frame
    at 30 minutes time point from application of treatment.
    Secondary Outcome Measure Information:
    Title
    Assessment of a patient's likelihood of using this method again as measured on a survey question
    Description
    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".
    Time Frame
    2 weeks from starting therapy
    Title
    Presence of scarring or skin discoloration
    Description
    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.
    Time Frame
    2 weeks from starting therapy

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    This is a study on perenial genital warts, near the vulvovaginal area. Only women have vulvovaginas.
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    22479897
    Citation
    Bakardzhiev I, Kovachev E. [Comparative assessment of the methods of treatment of Condylomata acuminata]. Akush Ginekol (Sofiia). 2011;50(4):45-51. Bulgarian.
    Results Reference
    background
    PubMed Identifier
    26239450
    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.
    Results Reference
    result
    PubMed Identifier
    13519856
    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.
    Results Reference
    result
    PubMed Identifier
    24643186
    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.
    Results Reference
    result

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    Cantharone for the Treatment of Perenial Warts

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