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Microwave Treatment of Common and Plantar Warts
Sponsor: Blackwell Device Consulting
Summary
This is a multi-center, open, randomized, parallel-group, controlled, blind-assessed trial of approximately 124 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.
Official title: Pivotal Study to Assess the Clinical Efficacy and Safety of Microwave Treatment in Warts
Key Details
Gender
All
Age Range
18 Years - 64 Years
Study Type
INTERVENTIONAL
Enrollment
119
Start Date
2022-07-06
Completion Date
2025-03
Last Updated
2024-05-21
Healthy Volunteers
No
Conditions
Interventions
Microwave Treatment (Swift System)
Localized microwave energy applied to the wart lesion. Treatment is in 4-week intervals (minimum of 2 treatments, maximum of 4 treatments). For common warts (usually hands, elbow, knees): Treatment starts at 6W and applied locally for a 2 second burst and the dose and duration is adjusted (up or down) as is tolerable for the subject. Treatment is repeated on the same wart as is tolerable (3-5 repetitions). For plantar warts: Treatment starts at 8W and applied locally for a 2 second burst and the dose and duration is adjusted (up or down) as is tolerable for the subject. Treatment is repeat on the same wart as is tolerable (3-5 repetitions). Less power for a longer time will result in a more gradual temperature rise. Higher power for a shorter time will result in a more immediate temperature rise.
Cryotherapy
Local application of Cryotherapy. Treatment is in 4-week intervals (minimum of 2 treatments, maximum of 4 treatments).
Locations (6)
Miami Dermatology and Laser Institute
Miami, Florida, United States
TrueBlue Clinical Research
Palm Harbor, Florida, United States
TrueBlue Clinical Research
Tampa, Florida, United States
Weil Foot & Ankle Institute
Chicago, Illinois, United States
Oak Dermatology
Naperville, Illinois, United States
Tennessee Clinical Research Center
Nashville, Tennessee, United States