Eligibility
18 - 65
All Sexes
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Study Summary
This is a multi-center, open, randomized, parallel-group, controlled, blind-assessed trial of approximately 110 subjects that require treatment for up to 5 common or plantar warts. Subjects will be randomized to one of two treatment groups: Microwave Treatment (Swift® system) or Cryotherapy.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 9 Secondary · Reporting Duration: 3 months, 6 months and 12 months post final treatment
Month 12
Adverse events
Month 3
Clearance of all treated warts at three months post final treatment, each of which is defined as "lesion no longer visible" but assessed by the majority of three independent blinded assessors using photographs
Clearance of all treated warts, each of which is defined as "resolved" or "not resolved" based on the classification by the blinded site investigator assessing the treated warts at three months post final treatment (up to 5 warts in total).
Efficacy of all warts classed as resolved by the blinded site investigator at three months post final treatment, by the number of warts treated
The resolution rate for individual warts based on the classification by the blinded site investigator at 3 months post-final treatment.
Month 12
Change from baseline for size of treated warts at three months, six months and at twelve months post final treatment
Patient reported pain score since last treatment at three, six and twelve months post final treatment
Month 12
Patient reported satisfaction with treatment at six and twelve months post final treatment
Month 12
Clearance of all treated warts, each of which is defined as "resolved" or "not resolved" based on the classification by the blinded site investigator assessing the treated warts at six months and twelve months post final treatment.
Reoccurrence of any treated wart at six and twelve months post final treatment, as classified by the blinded site investigator and separately by photos reviewed by the majority of the three independent blinded assessors.
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Cryotherapy Treatment
1 of 2
Microwave Treatment (Swift System)
1 of 2
Active Control
Experimental Treatment
110 Total Participants · 2 Treatment Groups
Primary Treatment: Microwave Treatment (Swift System) · No Placebo Group · N/A
Microwave Treatment (Swift System)
Device
Experimental Group · 1 Intervention: Microwave Treatment (Swift System) · Intervention Types: DeviceCryotherapy Treatment
Device
ActiveComparator Group · 1 Intervention: Cryotherapy · Intervention Types: DeviceTrial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 months, 6 months and 12 months post final treatment
Closest Location: Tennessee Clinical Research Center · Nashville, TN
2012First Recorded Clinical Trial
2 TrialsResearching Warts
76 CompletedClinical Trials
Eligibility Criteria
Age 18 - 65 · All Participants · 9 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You agree to not take any NSAIDs or antihistamines within a 12-hour period prior to and after randomization.
You are willing to comply with all study procedures and are available for the duration of the study.
You are between 22 and 64 years old.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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Cancer Related
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