Safety & Performance Study of Verruca Treatment Device
|ClinicalTrials.gov Identifier: NCT01536834|
Recruitment Status : Completed
First Posted : February 22, 2012
Last Update Posted : October 11, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Verruca Plantar Wart||Device: Medical Device||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||February 2013|
Experimental: Medical Device
The Investigational device is a liquid in a delivery system for the treatment of verrucas
|Device: Medical Device|
- Safety Endpoint [ Time Frame: 4 weeks ]Safety will be assessed in terms of severity, frequency and seriousness of any complications, adverse events or adverse device effects.
- Efficacy endpoint presence/absence of verruca by podiatrist [ Time Frame: 4 weeks ]Presence (& Area) or absence of verruca at each visit, as determined by podiatrist using photographic data.
- Efficacy endpoint presence/absence of verruca and pain by patient [ 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01536834
|Mr. Andrew Ryals|
|Wakefield, Yorkshire, United Kingdom, WF1 2TF|