Safety & Performance Study of Verruca Treatment Device

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)

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.

Study Overview

• Status: Completed
• Conditions: Plantar Wart; Verruca
• Intervention / Treatment: Device: Medical Device

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Yorkshire
    • Wakefield, Yorkshire, United Kingdom, WF1 2TF
      • Mr. Andrew Ryals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Medical Device; The Investigational device is a liquid in a delivery system for the treatment of verrucas	Device: Medical Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Endpoint	Safety will be assessed in terms of severity, frequency and seriousness of any complications, adverse events or adverse device effects.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy endpoint presence/absence of verruca by podiatrist	Presence (& Area) or absence of verruca at each visit, as determined by podiatrist using photographic data.	4 weeks
Efficacy endpoint presence/absence of verruca and pain by patient	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.	4 weeks

Collaborators and Investigators

• Sponsor: Reckitt Benckiser LLC

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: February 16, 2012
• First Submitted That Met QC Criteria: February 16, 2012
• First Posted (Estimate): February 22, 2012

Study Record Updates

• Last Update Posted (Actual): October 11, 2017
• Last Update Submitted That Met QC Criteria: October 10, 2017
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: Medical Device; Podiatry; Verruca; Plantar Wart; Footcare
• Additional Relevant MeSH Terms: Skin Diseases; Virus Diseases; Infections; Musculoskeletal Diseases; DNA Virus Infections; Skin Diseases, Infectious; Papillomavirus Infections; Skin Diseases, Viral; Tumor Virus Infections; Warts; Foot Diseases
• Other Study ID Numbers: NPD396 02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No