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Completed

NCT Number: NCT01536834

Safety & Performance Study of Verruca Treatment Device

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mr. Andrew Ryals

Wakefield, Yorkshire, WF1 2TF, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medical Device

Device

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Reckitt Benckiser LLC

Industry

Registry information

Official study 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)

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Feb 22, 2012
Registry last updated
Oct 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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