Back to resultsSafety & Performance Study of Verruca Treatment Device
Primary Purpose
Verruca, Plantar Wart
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Medical Device
Sponsored by
About this trial
This is an interventional treatment trial for Verruca focused on measuring Verruca, Plantar Wart, Medical Device, Podiatry, Footcare
Eligibility Criteria
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
Sites / Locations
- Mr. Andrew Ryals
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Medical Device
Arm Description
The Investigational device is a liquid in a delivery system for the treatment of verrucas
Outcomes
Primary Outcome Measures
Safety Endpoint
Safety will be assessed in terms of severity, frequency and seriousness of any complications, adverse events or adverse device effects.
Secondary Outcome Measures
Efficacy endpoint presence/absence of verruca by podiatrist
Presence (& Area) or absence of verruca at each visit, as determined by podiatrist using photographic data.
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.
Full Information
NCT ID
NCT01536834
First Posted
February 16, 2012
Last Updated
October 10, 2017
Sponsor
Reckitt Benckiser LLC
1. Study Identification
Unique Protocol Identification Number
NCT01536834
Brief Title
Safety & Performance Study of Verruca Treatment Device
Official 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)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Reckitt Benckiser LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Verruca, Plantar Wart
Keywords
Verruca, Plantar Wart, Medical Device, Podiatry, Footcare
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Medical Device
Arm Type
Experimental
Arm Description
The Investigational device is a liquid in a delivery system for the treatment of verrucas
Intervention Type
Device
Intervention Name(s)
Medical Device
Primary Outcome Measure Information:
Title
Safety Endpoint
Description
Safety will be assessed in terms of severity, frequency and seriousness of any complications, adverse events or adverse device effects.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Efficacy endpoint presence/absence of verruca by podiatrist
Description
Presence (& Area) or absence of verruca at each visit, as determined by podiatrist using photographic data.
Time Frame
4 weeks
Title
Efficacy endpoint presence/absence of verruca and pain by patient
Description
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.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Mr. Andrew Ryals
City
Wakefield
State/Province
Yorkshire
ZIP/Postal Code
WF1 2TF
Country
United Kingdom
12. IPD Sharing Statement
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Safety & Performance Study of Verruca Treatment Device
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