Back to resultsA Trial Examining the Treatment of Common Warts With Combination Liquid Nitrogen (LN2) and Cantharidin
Primary Purpose
Verruca Vulgaris
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Liquid nitrogen and cantharidin
Liquid nitrogen and topical placebo
Sponsored by
About this trial
This is an interventional treatment trial for Verruca Vulgaris focused on measuring Warts, Verruca vulgaris, Liquid Nitrogen, Cantharidin, combination treatment
Eligibility Criteria
Inclusion Criteria:
- common warts on non-genital, non-facial skin
- otherwise healthy
- between 18-65 and able to give informed consent
- capable of tolerating treatment
Exclusion Criteria:
- Ill-health
- Poor tolerance or sensitivity to treatments in study
- <18 years old; >65 years old
- verruca plana or condyloma acuminata
- immunosuppression or immune dysfunction
- significant peripheral vascular disease
- significant sensitivity to cold
- epidermodysplasia verruciformis
- mosaiform warts or periungual warts
Sites / Locations
- North Idaho Dermatology
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Liquid nitrogen and canthardin
Liquid nitrogen and placebo
Arm Description
Liquid nitrogen applied to wart(s), then cantharidin 1% topical applied afterwards.
Liquid nitrogen applied to wart(s) then placebo vehicle afterwards.
Outcomes
Primary Outcome Measures
Percentage of common warts cleared
Percentage of treated warts cleared with treatment, as measured with dermatoscopic examination, after 12 weeks.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01084824
Brief Title
A Trial Examining the Treatment of Common Warts With Combination Liquid Nitrogen (LN2) and Cantharidin
Official Title
A Randomized Clinical Trial Examining the Efficacy of Treatment of Cutaneous Verruca Vulgaris in Adult Patients With Combined Liquid Nitrogen Cryotherapy and Topically Applied Cantharidin
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
North Idaho Dermatology
4. Oversight
5. Study Description
Brief Summary
The purpose of the study was to see if liquid nitrogen, a commonly used treatment for warts, is more effective if it is used alone, or if it is more effective if combined with cantharidin, a topical treatment also commonly used for warts (verruca vulgaris).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Verruca Vulgaris
Keywords
Warts, Verruca vulgaris, Liquid Nitrogen, Cantharidin, combination treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Liquid nitrogen and canthardin
Arm Type
Active Comparator
Arm Description
Liquid nitrogen applied to wart(s), then cantharidin 1% topical applied afterwards.
Arm Title
Liquid nitrogen and placebo
Arm Type
Placebo Comparator
Arm Description
Liquid nitrogen applied to wart(s) then placebo vehicle afterwards.
Intervention Type
Drug
Intervention Name(s)
Liquid nitrogen and cantharidin
Intervention Description
Liquid nitrogen applied to wart(s), then cantharidin 1% topical applied afterward.
Intervention Type
Drug
Intervention Name(s)
Liquid nitrogen and topical placebo
Intervention Description
Liquid nitrogen applied to wart(s), then placebo vehicle applied thereafter.
Primary Outcome Measure Information:
Title
Percentage of common warts cleared
Description
Percentage of treated warts cleared with treatment, as measured with dermatoscopic examination, after 12 weeks.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
common warts on non-genital, non-facial skin
otherwise healthy
between 18-65 and able to give informed consent
capable of tolerating treatment
Exclusion Criteria:
Ill-health
Poor tolerance or sensitivity to treatments in study
<18 years old; >65 years old
verruca plana or condyloma acuminata
immunosuppression or immune dysfunction
significant peripheral vascular disease
significant sensitivity to cold
epidermodysplasia verruciformis
mosaiform warts or periungual warts
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard A Flygare, PhD
Organizational Affiliation
TUI University; North Idaho Dermatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
North Idaho Dermatology
City
Coeur D'Alene
State/Province
Idaho
ZIP/Postal Code
83814
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
7857844
Citation
Berth-Jones J, Bourke J, Eglitis H, Harper C, Kirk P, Pavord S, Rajapakse R, Weston P, Wiggins T, Hutchinson PE. Value of a second freeze-thaw cycle in cryotherapy of common warts. Br J Dermatol. 1994 Dec;131(6):883-6. doi: 10.1111/j.1365-2133.1994.tb08594.x.
Results Reference
background
PubMed Identifier
8089292
Citation
Guidelines of care for cryosurgery. American Academy of Dermatology Committee on Guidelines of Care. J Am Acad Dermatol. 1994 Oct;31(4):648-53. No abstract available.
Results Reference
background
PubMed Identifier
11594862
Citation
Moed L, Shwayder TA, Chang MW. Cantharidin revisited: a blistering defense of an ancient medicine. Arch Dermatol. 2001 Oct;137(10):1357-60. doi: 10.1001/archderm.137.10.1357.
Results Reference
background
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A Trial Examining the Treatment of Common Warts With Combination Liquid Nitrogen (LN2) and Cantharidin
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