- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01084824
A Trial Examining the Treatment of Common Warts With Combination Liquid Nitrogen (LN2) and Cantharidin
March 10, 2010 updated by: North Idaho Dermatology
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
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Idaho
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Coeur D'Alene, Idaho, United States, 83814
- North Idaho Dermatology
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Liquid nitrogen and canthardin
Liquid nitrogen applied to wart(s), then cantharidin 1% topical applied afterwards.
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Liquid nitrogen applied to wart(s), then cantharidin 1% topical applied afterward.
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Placebo Comparator: Liquid nitrogen and placebo
Liquid nitrogen applied to wart(s) then placebo vehicle afterwards.
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Liquid nitrogen applied to wart(s), then placebo vehicle applied thereafter.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of common warts cleared
Time Frame: 12 weeks
|
Percentage of treated warts cleared with treatment, as measured with dermatoscopic examination, after 12 weeks.
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Richard A Flygare, PhD, TUI University; North Idaho Dermatology
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2007
Primary Completion (Actual)
June 1, 2008
Study Completion (Actual)
September 1, 2008
Study Registration Dates
First Submitted
March 10, 2010
First Submitted That Met QC Criteria
March 10, 2010
First Posted (Estimate)
March 11, 2010
Study Record Updates
Last Update Posted (Estimate)
March 11, 2010
Last Update Submitted That Met QC Criteria
March 10, 2010
Last Verified
March 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NID-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Nielsen BioSciences, Inc.Completed
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Universidad Complutense de MadridUnknown
-
University of Maryland, BaltimoreTerminated