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
About this trial
This is an interventional treatment trial for Wart, Genital focused on measuring warts, trichloroacetic acid
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
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
NCT ID
NCT03625960
First Posted
August 2, 2018
Last Updated
August 7, 2018
Sponsor
Wayne State University
Collaborators
University of California, San Francisco, St Vincent's Hospital
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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