Onychomycosis of ToenailsNCT02131363
A Clinical Investigation to Evaluate the Safety and Performance of a Treatment Kit for Ingrowing Toenail
A study testing Ingrowing Toenail Treatment Kit in people with Onychomycosis of Toenails, run by Reckitt Benckiser Healthcare (UK) Limited at 1 site in United Kingdom.
Trial summary
This purpose of this study is to evaluate the safety and performance of a treatment kit for ingrowing toenail, primarily by determining the number of subjects who show a reduction in the severity of their ingrowing toenail. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Onychomycosis of Toenails
- What is being tested?
- Ingrowing Toenail Treatment Kit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2014to Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with one great ingrowing toenail that is rated as either "slightly ingrowing", "somewhat ingrowing" or "very ingrowing" on the Investigators Ingrowing Toenail Severity Scale.
- Subjects whose worst pain experienced in the week preceding inclusion, is rated at least 3 on the 10 point Subject Pain Intensity Scale.
- Subjects whose affected toenail has a minimum of 2mm distal edge and a minimum nail width of at least 16mm.
Who cannot join
- Subjects with any other toenail pathology (including pincer and spicule toenail) that would compromise the fitting of the toenail clip, or its use.
- Subjects suspected to be immunocompromised.
- Subjects who suffer from impaired feeling in the feet due to diabetes, peripheral vascular disease or neuropathy.
- Subjects with any cutaneous pathology or cuts/abrasions which, in the opinion of the investigator, could compromise safety or affect the outcome of the clinical investigation (for example, interfere with assessments).
- Subjects with known sensitivity/allergies to any component of the investigational device.
- 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 subject or affect the outcome of the clinical investigation (as determined from self-reported medical history questionnaire).
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- Use of concomitant medication likely to affect the response to the investigational device or confuse the results of the clinical investigation. Regular pain relief is not permitted and subjects must not take any analgesics in the 24 hours preceding any clinic visit.
- Female subjects of childbearing potential who, for the duration of the study, are either unwilling or unable to take adequate contraceptive precautions or are unwilling to be sexually abstinent.
- Pregnancy or lactating mother.
Trial locations and contacts
1 site in 1 country.
About this study
This purpose of this study is to evaluate the safety and performance of a treatment kit for ingrowing toenail, primarily by determining the number of subjects who show a reduction in the severity of their ingrowing toenail.
- Conditions
- Onychomycosis of Toenails
- Being tested
- Ingrowing Toenail Treatment Kit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ingrowing Toenail Treatment KitDevice
detailed in arm description
| Study group | Role | What they receive |
|---|---|---|
| Ingrowing Toenail Treatment Kit | Experimental | Ingrowing Toenail Treatment Kit consists of 3 components:
1. Toe nail clip: one clip to be applied each week, for 6 weeks.
2. Aerosol spray: to be applied up to 5 times a day, no more than one spray per hour.
3. Nail adhesive: used to attach the clip to the nail. Receives: Device: Ingrowing Toenail Treatment Kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects who demonstrate a reduction in the severity of their ingrowing toenail
This will be assessed by the Investigator, using the Investigator Ingrowing Toenail Severity Scale.
Measured: At Day 42 from Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2014 (estimated)
- Study startAug 2014
- Primary completionNov 2014
- Study completionDec 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reckitt Benckiser Healthcare (UK) Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02131363
- Sponsor's protocol ID
- NPD21402
- Status last verified
- Sep 2014
- First submitted
- 2 May 2014
- Last updated
- 13 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Investigation to Evaluate the Safety and Performance of a Treatment Kit for Ingrowing Toenail
- ClinicalTrials.gov ID
- NCT02131363
- Acronym / sponsor ID
- NPD21402
- Conditions
- Onychomycosis of Toenails
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Reckitt Benckiser Healthcare (UK) LimitedIndustry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 6 May 2014 (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 purpose of this study is to evaluate the safety and performance of a treatment kit for ingrowing toenail, primarily by determining the number of subjects who show a reduction in the severity of their ingrowing toenail.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ingrowing Toenail Treatment Kit | Experimental | Device: Ingrowing Toenail Treatment KitIngrowing Toenail Treatment Kit consists of 3 components: 1. Toe nail clip: one clip to be applied each week, for 6 weeks. 2. Aerosol spray: to be applied up to 5 times a day, no more than one spray per hour. 3. Nail adhesive: used to attach the clip to the nail. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects with one great ingrowing toenail that is rated as either "slightly ingrowing", "somewhat ingrowing" or "very ingrowing" on the Investigators Ingrowing Toenail Severity Scale.
- Subjects whose worst pain experienced in the week preceding inclusion, is rated at least 3 on the 10 point Subject Pain Intensity Scale.
- Subjects whose affected toenail has a minimum of 2mm distal edge and a minimum nail width of at least 16mm.
Key exclusion criteria (9 listed)
- Subjects with any other toenail pathology (including pincer and spicule toenail) that would compromise the fitting of the toenail clip, or its use.
- Subjects suspected to be immunocompromised.
- Subjects who suffer from impaired feeling in the feet due to diabetes, peripheral vascular disease or neuropathy.
- Subjects with any cutaneous pathology or cuts/abrasions which, in the opinion of the investigator, could compromise safety or affect the outcome of the clinical investigation (for example, interfere with assessments).
- Subjects with known sensitivity/allergies to any component of the investigational device.
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 |
|---|---|---|
| Ingrowing Toenail Treatment Kitdetailed in arm description | Device | Ingrowing Toenail Treatment Kit |
Primary outcome
The proportion of subjects who demonstrate a reduction in the severity of their ingrowing toenail
Time frame: At Day 42 from Day 0
This will be assessed by the Investigator, using the Investigator Ingrowing Toenail Severity Scale.
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 13 Jan 2015.
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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 Ingrowing Toenail Treatment Kit 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 3 inclusion and 9 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 13 Jan 2015. 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?
The proportion of subjects who demonstrate a reduction in the severity of their ingrowing toenail (time frame: At Day 42 from Day 0). 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 13 Jan 2015.