Onychomycosis of ToenailsNCT02546258
Evaluation of the Performance of a Fungal Nail Treatment on the Visual Signs of Onychomycosis
A study testing A Fungal Nail Treatment in people with Onychomycosis of Toenails, run by Reckitt Benckiser Healthcare (UK) Limited at 1 site in United Kingdom.
Trial summary
This is a prospective, open label, non-comparative clinical investigation to evaluate the performance of a Fungal Nail Treatment on the visual signs of onychomycosis. The Fungal Nail Treatment is a CE Marked Class I Medical Device and is commercially available as an over-the-counter product. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Onychomycosis of Toenails
- What is being tested?
- A Fungal Nail Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Aug 2014to 21 Nov 2014
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent has been obtained.
- Age between 18 years to 65 years inclusive.
- Gender: male and female subjects.
- Subjects with visual signs of MILD fungal nail infection present on at least one big toenail or with fungal nail infection on one other toenail on the same foot, in addition to the target big toenail (condition of other foot not relevant) as per podiatrist visual assessment.
- Subjects with no more than 50% surface area of the target big toenail visually affected, from the leading distal edge, as assessed by the podiatrist.
Who cannot join
- Subjects with moderate to severe fungal toenail infection, on either big toenail, as determined by podiatrist assessment.
- Subjects with fungal nail infection on more than two toenails on their target foot.
- Subjects reporting presence of visual symptoms of fungal toenail infection for more than five years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Open Label, Non-comparative Clinical Investigation to Evaluate the Performance of a Fungal Nail Treatment on the Visual Signs of Onychomycosis
This is a prospective, open label, non-comparative clinical investigation to evaluate the performance of a Fungal Nail Treatment on the visual signs of onychomycosis.
The Fungal Nail Treatment is a CE Marked Class I Medical Device and is commercially available as an over-the-counter product.
The ability of the Fungal Nail Treatment to treat the visual signs of mild fungal toenail infections will be determined by a reduction in the surface area of the infection over time. This will be assessed through visual quantification of the infected area from baseline, as measured by image analysis, throughout the treatment period, where subjects will follow instructions for use on the product pack and self-treat for the duration of the investigation or until their condition has resolved. Both subject and podiatrist will assess the improvement of signs and symptoms of the target nail.
- Conditions
- Onychomycosis of Toenails
- Being tested
- A Fungal Nail Treatment
- Keywords
- Fungal Nail
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A Fungal Nail TreatmentDevice
Also called Funagl Nail Treatment
treats the signs of mild fungal nail infections
| Study group | Role | What they receive |
|---|---|---|
| A Funagl Nail Treatment | Other | Marketed treatment of Fungal Nail Follow instructions on pack Receives: Device: A Fungal Nail Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage reduction of the surface area of infection over time using image analysis
Measured: 40 weeks
Secondary outcomes (2)
Percentage reduction of the surface area of infection over time from baseline to week 4 using image analysis
Measured: 4 weeks
The proportion of subjects whose fungal nail infection has resolved
Measured: 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2015 (estimated)
- Study start25 Aug 2014
- Primary completion21 Nov 2014
- Study completion21 Nov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Onychomycosis of ToenailsStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reckitt Benckiser Healthcare (UK) Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Intertek
- Responsible party
- Sponsor
- Investigators
- Rashid Haye, MBBS MD, Principal investigator, Intertek CRS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02546258
- Sponsor's protocol ID
- NPD810
- Status last verified
- Nov 2015
- First submitted
- 8 Sep 2015
- Last updated
- 11 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open Label, Non-comparative Clinical Investigation to Evaluate the Performance of a Fungal Nail Treatment on the Visual Signs of Onychomycosis
- ClinicalTrials.gov ID
- NCT02546258
- Acronym / sponsor ID
- NPD810
- Conditions
- Onychomycosis of Toenails
- Keywords
- Fungal Nail
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Reckitt Benckiser Healthcare (UK) LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Intertek
- Study start
- 25 Aug 2014 (actual)
- Primary completion
- 21 Nov 2014 (actual)
- Study completion
- 21 Nov 2014 (actual)
- First posted
- 10 Sep 2015 (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 prospective, open label, non-comparative clinical investigation to evaluate the performance of a Fungal Nail Treatment on the visual signs of onychomycosis.
The Fungal Nail Treatment is a CE Marked Class I Medical Device and is commercially available as an over-the-counter product.
The ability of the Fungal Nail Treatment to treat the visual signs of mild fungal toenail infections will be determined by a reduction in the surface area of the infection over time. This will be assessed through visual quantification of the infected area from baseline, as measured by image analysis, throughout the treatment period, where subjects will follow instructions for use on the product pack and self-treat for the duration of the investigation or until their condition has resolved. Both subject and podiatrist will assess the improvement of signs and symptoms of the target nail.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A Funagl Nail Treatment | Other | Device: A Fungal Nail TreatmentMarketed treatment of Fungal Nail Follow instructions on pack |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Informed consent has been obtained.
- Age between 18 years to 65 years inclusive.
- Gender: male and female subjects.
- Subjects with visual signs of MILD fungal nail infection present on at least one big toenail or with fungal nail infection on one other toenail on the same foot, in addition to the target big toenail (condition of other foot not relevant) as per podiatrist visual assessment.
- Subjects with no more than 50% surface area of the target big toenail visually affected, from the leading distal edge, as assessed by the podiatrist.
Key exclusion criteria (3 listed)
- Subjects with moderate to severe fungal toenail infection, on either big toenail, as determined by podiatrist assessment.
- Subjects with fungal nail infection on more than two toenails on their target foot.
- Subjects reporting presence of visual symptoms of fungal toenail infection for more than five years.
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 |
|---|---|---|
| A Fungal Nail TreatmentAlso: Funagl Nail Treatmenttreats the signs of mild fungal nail infections | Device | A Funagl Nail Treatment |
Primary outcome
Percentage reduction of the surface area of infection over time using image analysis
Time frame: 40 weeks
2 secondary outcomes
Percentage reduction of the surface area of infection over time from baseline to week 4 using image analysis
Time frame: 4 weeks
The proportion of subjects whose fungal nail infection has resolved
Time frame: 40 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 Apr 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.
Rashid Haye, MBBS MD principal investigator
Intertek CRS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A Fungal Nail Treatment in people with Onychomycosis of Toenails, run by Reckitt Benckiser Healthcare (UK) Limited 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 5 inclusion and 3 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 Apr 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?
Percentage reduction of the surface area of infection over time using image analysis (time frame: 40 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 Apr 2017.