Safety & Performance Study of Verruca Treatment Device

Reckitt Benckiser

Status

Completed

Conditions

Verruca

Plantar Wart

Treatments

Device: Medical Device

Study type

Interventional

Funder types

Industry

Identifiers

NCT01536834

NPD396 02

Details and patient eligibility

About

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.

Enrollment

35 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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