Adult Vettel Pilot Clinical Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Reckitt Benckiser LLC.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Reckitt Benckiser LLC
ClinicalTrials.gov Identifier:
NCT01536834
First received: February 16, 2012
Last updated: February 22, 2012
Last verified: February 2012
  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
Plantar Wart
Device: Vettel

Study Type: Interventional
Study Design: Masking: 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:

Estimated Enrollment: 40
Arms Assigned Interventions
Experimental: Vettel Device: Vettel

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01536834

Locations
United Kingdom
Mr. Andrew Ryals Not yet recruiting
West Yorkshire, United Kingdom, WF1 2TF
Contact: Andrew Ryals    01924369077    foo823@hotmail.com   
Sponsors and Collaborators
Reckitt Benckiser LLC
  More Information

No publications provided

Responsible Party: Reckitt Benckiser LLC
ClinicalTrials.gov Identifier: NCT01536834     History of Changes
Other Study ID Numbers: NPD396 02
Study First Received: February 16, 2012
Last Updated: February 22, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

ClinicalTrials.gov processed this record on September 22, 2014