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)
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