Mr. Andrew Ryals
Wakefield, Yorkshire, WF1 2TF, United Kingdom
NCT Number: NCT01536834
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Wakefield, Yorkshire, WF1 2TF, United Kingdom
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 4 weeks
Safety will be assessed in terms of severity, frequency and seriousness of any complications, adverse events or adverse device effects.
Time frame: 4 weeks
Presence (& Area) or absence of verruca at each visit, as determined by podiatrist using photographic data.
Time frame: 4 weeks
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.
Reckitt Benckiser LLC
Industry
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)
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