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.
The primary objective of this study is to collect evidence of the effectiveness of the Swift device for the treatment of common and plantar warts and compare with Cryotherapy. The secondary objectives of this study are to collect evidence of the safety, effectiveness and patient experiences of the Swift device for the treatment of common and plantar warts and compare with Cryotherapy. Eligible subjects who provide written informed consent will be randomized to either Microwave Treatment or Cryotherapy. Each eligible subject will receive treatment at the baseline visit (Visit 2) and again 4-weeks later. Subjects will receive a minimum of 2 treatments or, if further treatment is required, up to a maximum of 4 treatments; each treatment is given in 4-week intervals. Follow-up is 12-weeks after the last treatment has been administered where the warts will be assessed for resolution. Further follow-up visits occur 6-months and 12-months after the last treatment where the warts will be assessed for resolution or reoccurrence (if resolved at the 12-week visit).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
119
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.
Local application of Cryotherapy. Treatment is in 4-week intervals (minimum of 2 treatments, maximum of 4 treatments).
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
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).
Time frame: 3 months post final treatment
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
Time frame: 3 months post final treatment
Efficacy of all warts classed as resolved by the blinded site investigator at three months post final treatment, by the number of warts treated
Time frame: 3 months post final treatment
Patient reported satisfaction with treatment at six and twelve months post final treatment
A patient reported satisfaction questionnaire will be completed. The questionnaire relates to how satisfied the subject was about their treatment and likes/ dislikes about their treatment.
Time frame: 6 and 12 months post final treatment
Adverse events
Time frame: 12 months post final treatment
Change from baseline for size of treated warts at three months, six months and at twelve months post final treatment
Time frame: 3 months, 6 months and 12 months post final treatment
Patient reported pain score since last treatment at three, six and twelve months post final treatment
The subject will be asked to rate the worst pain they have experienced (None, Mild, Moderate, Severe).
Time frame: 3 months, 6 months and 12 months post final treatment
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Oak Dermatology
Naperville, Illinois, United States
Tennessee Clinical Research Center
Nashville, Tennessee, United States
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.
Time frame: 6 months and 12 months post final treatment
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.
Time frame: 6 months and 12 months post final treatment
The resolution rate for individual warts based on the classification by the blinded site investigator at 3 months post-final treatment.
Time frame: 3 months post final treatment