Safety & Performance Study of Verruca Treatment Device

NCT01536834 | Completed

• 1 other identifier: NPD396 02
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Verruca; Plantar Wart

Keywords

Verruca; Plantar Wart; Medical Device; Podiatry; Footcare

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Efficacy endpoint presence/absence of verruca by podiatrist

  4 weeks

• Efficacy endpoint presence/absence of verruca and pain by patient

  4 weeks

Study Arms (1)

Medical Device

EXPERIMENTAL

The Investigational device is a liquid in a delivery system for the treatment of verrucas

Device: Medical Device

Interventions

Medical Device DEVICE

Medical Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Reckitt Benckiser LLC: lead

Study Sites (1)

Mr. Andrew Ryals

Wakefield, Yorkshire, WF1 2TF, United Kingdom

Location

MeSH Terms

Conditions

Warts

Interventions

Equipment and Supplies

Condition Hierarchy (Ancestors)

Papillomavirus Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Tumor Virus Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2012
• First Posted: February 22, 2012
• Study Start: June 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: February 1, 2013
• Last Updated: October 11, 2017

Record last verified: 2012-02

Locations

GB (1)