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This is a non comparative pre-CE marking pilot clinical investigation is required to evaluate the safety and performance in intended use of the Verruca treatment - NPD396, Class IIa medical device for verrucas in the adult population. The treatment regime will be topical application of the Verruca treatment to the verruca, identified as the reference, once daily for 4 weeks.
Patient & investigator derived outcomes will also be collected to assess clinical performance and adverse events and adverse device effects will be reported to assess safety profile.
Patient assessments will take place pre-treatment to determine patient demography, baseline clinical status, pain and verruca size prior to treatment. Compliance with treatment schedule will be collected via patient diary cards. Furthermore, patients will be assessed on day 2 after starting treatment and then again at 7, 14, 21 & 28 days after starting treatment. Diary cards will completed through-out the investigation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medical Device | Experimental | The Investigational device is a liquid in a delivery system for the treatment of verrucas |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medical Device | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety Endpoint | Safety will be assessed in terms of severity, frequency and seriousness of any complications, adverse events or adverse device effects. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy endpoint presence/absence of verruca by podiatrist | Presence (& Area) or absence of verruca at each visit, as determined by podiatrist using photographic data. | 4 weeks |
| Efficacy endpoint presence/absence of verruca and pain by patient |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mr. Andrew Ryals | Wakefield | Yorkshire | WF1 2TF | United Kingdom |
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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 |
|---|---|
| D004864 | Equipment and Supplies |
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Patient's assessment of presence or absence of the verruca and associated pain during follow-up period using VAS within diary cards. A set of Patient perception questions will also be included in the diary card.
| 4 weeks |
| D017193 |
| Skin Diseases, Viral |
| D014412 | Tumor Virus Infections |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |