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Safety & Performance Study of Verruca Treatment Device

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01536834
First Posted: February 22, 2012
Last Update Posted: October 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Reckitt Benckiser LLC
  Purpose

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.


Condition Intervention
Verruca Plantar Wart Device: Medical Device

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Reckitt Benckiser LLC:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

  • 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.


Enrollment: 35
Study Start Date: June 2012
Study Completion Date: February 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Medical Device
The Investigational device is a liquid in a delivery system for the treatment of verrucas
Device: Medical Device

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01536834


Locations
United Kingdom
Mr. Andrew Ryals
Wakefield, Yorkshire, United Kingdom, WF1 2TF
Sponsors and Collaborators
Reckitt Benckiser LLC
  More Information

Responsible Party: Reckitt Benckiser LLC
ClinicalTrials.gov Identifier: NCT01536834     History of Changes
Other Study ID Numbers: NPD396 02
First Submitted: February 16, 2012
First Posted: February 22, 2012
Last Update Posted: October 11, 2017
Last Verified: February 2012

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Reckitt Benckiser LLC:
Verruca
Plantar Wart
Medical Device
Podiatry
Footcare

Additional relevant MeSH terms:
Warts
Foot Diseases
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases
Musculoskeletal Diseases