Clinical trial NCT01536834: Safety & Performance Study of Verruca Treatment Device
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Verruca
Plantar Wart
Keywords: Verruca
Plantar Wart
Medical Device
Podiatry
Footcare
Lead sponsor: Reckitt Benckiser LLC
Sponsor class: INDUSTRY
First posted: 2012-02-22
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Male or female patients aged \>18 years
* Patients with verrucas
* Patients should be willing to take part, able to understand the information given to them and give written consent

Exclusion Criteria:

* Patient with more than two areas affected by verrucas on one foot
* Patient who are actively treating or have treated their wart within the past 8 weeks
* Patient suspected to be immunocompromised or are taking immunosuppressants
* Patient who suffer from impaired feeling due to diabetes, peripheral vascular disease or neuropathy.
* Current participation in another clinical investigation or participation within the last 30 days.
* Patient with known sensitivity/allergies to the test materials or any of their ingredients.
* Significant current or past medical history of hepatic, renal, cardiac, pulmonary, digestive, haematological, neurological, locomotor or psychiatric disease, which, in the opinion of the Investigator, would compromise the safety of the volunteer or affect the outcome of the investigation (as determined from self-reported medical history questionnaire).
* Patient in a situation which in the view of the investigator could interfere with optimal participation in the investigation or constitute a special risk for these patients.
* Patient who scar easily or are prone to hypertrophic or Keloid scarring.
* Patient who have previously had an unfavourable reaction to any products for the feet and which involved swelling of the foot, or a requirement for painkillers or antibiotics.
* Pregnant and lactating females, or those actively seeking to become pregnant in the next month

Primary outcomes:
measure: Safety Endpoint
timeFrame: 4 weeks
Secondary outcomes:
measure: Efficacy endpoint presence/absence of verruca by podiatrist
timeFrame: 4 weeks
measure: Efficacy endpoint presence/absence of verruca and pain by patient
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Wakefield
country: United Kingdom
facility: Mr. Andrew Ryals
state: Yorkshire
Study officials:
References: