VerrucaNCT01536834
Safety & Performance Study of Verruca Treatment Device
A study testing Medical Device in people with Verruca and Plantar Wart, run by Reckitt Benckiser LLC at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Verruca, Plantar Wart
- What is being tested?
- Medical Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2012to Feb 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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
- Being tested
- Medical Device
- Keywords
- Verruca, Plantar Wart, Medical Device, Podiatry, Footcare
- Medical subject headings
- Warts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical DeviceDevice
| Study group | Role | What they receive |
|---|---|---|
| Medical Device | Experimental | The Investigational device is a liquid in a delivery system for the treatment of verrucas Receives: Device: Medical Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Endpoint
Safety will be assessed in terms of severity, frequency and seriousness of any complications, adverse events or adverse device effects.
Measured: 4 weeks
Secondary outcomes (2)
Efficacy endpoint presence/absence of verruca by podiatrist
Presence (\& Area) or absence of verruca at each visit, as determined by podiatrist using photographic data.
Measured: 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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2012 (estimated)
- Study startJun 2012
- Primary completionJan 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VerrucaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reckitt Benckiser LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01536834
- Sponsor's protocol ID
- NPD396 02
- Status last verified
- Feb 2012
- First submitted
- 16 Feb 2012
- Last updated
- 11 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01536834
- Acronym / sponsor ID
- NPD396 02
- Conditions
- Verruca, Plantar Wart
- Keywords
- Verruca, Plantar Wart, Medical Device, Podiatry, Footcare
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Reckitt Benckiser LLCIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 22 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Medical Device | Experimental | Device: Medical DeviceThe Investigational device is a liquid in a delivery system for the treatment of verrucas |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical Device | Device | Medical Device |
Primary outcome
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.
2 secondary outcomes
Efficacy endpoint presence/absence of verruca by podiatrist
Time frame: 4 weeks
Efficacy endpoint presence/absence of verruca and pain by patient
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical Device in people with Verruca and Plantar Wart, run by Reckitt Benckiser LLC at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Endpoint (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2017.