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| Name | Class |
|---|---|
| Emblation Limited | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Microwave Treatment (Swift System) | Experimental | 5-10 Watts of microwave energy applied locally on each wart for a 2-3 second burst with 3-5 repetitions per lesion. |
|
| Cryotherapy Treatment | Active Comparator | For each wart, two cycles of cryotherapy treatment is administered. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microwave Treatment (Swift System) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 3 months post final treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr Bhatia | Oak Dermatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miami Dermatology and Laser Institute | Miami | Florida | 33173 | United States | ||
| TrueBlue Clinical Research |
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| ID | Term |
|---|---|
| D014860 | Warts |
| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D017679 | Cryotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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This is an open label study, however, there is a blinded site investigator at each site who will not be aware of the treatment group the subject is assigned. The blinded site investigator will assess resolution and reoccurrence of the warts. Photos of the warts will be taken and these will be reviewed by three independent blinded assessors to assess wart resolution and reoccurrence.
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| Cryotherapy | Device | Local application of Cryotherapy. Treatment is in 4-week intervals (minimum of 2 treatments, maximum of 4 treatments). |
|
| 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. | 6 and 12 months post final treatment |
| Adverse events | 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 | 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). | 3 months, 6 months and 12 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. | 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. | 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. | 3 months post final treatment |
| Palm Harbor |
| Florida |
| 34685 |
| United States |
| TrueBlue Clinical Research | Tampa | Florida | 33609 | United States |
| Weil Foot & Ankle Institute | Chicago | Illinois | 60642 | United States |
| Oak Dermatology | Naperville | Illinois | 60563 | United States |
| Tennessee Clinical Research Center | Nashville | Tennessee | 37215 | United States |
| D017193 |
| Skin Diseases, Viral |
| D014412 | Tumor Virus Infections |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |