Plantar Wart Clinical Trial
Official title:
A Pilot Clinical Investigation in Adults to Evaluate the Safety and Performance of a Class IIa Medical Device for the Treatment of Plantar Warts (Verrucas)
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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