Onychomycosis of ToenailNCT04084782
An Internet Mediated Research Study to Assess the Quality of Life of Consumers With Self-reported Fungal Nail Infection (Onychomycosis) During Treatment With Scholl Fungal Nail.
An observational study of Onychomycosis of Toenail, run by Reckitt Benckiser Healthcare (UK) Limited at 1 site in United Kingdom.
Trial summary
To evaluate the effect on quality of life of consumers with self-reported onychomycosis during the first 4 weeks of treatment in relation to the appearance of the infected toenail. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Onychomycosis of Toenail
- What is being tested?
- Fungal Nail Treatment Kit
- Type of treatment
- Medical device
- How many people
- 70 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Aug 2019to Dec 2019
- Phase
- Observational
- 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
Study population: The study is targeting consumers who chose to self-treat by purchasing the Fungal Nail product from the eCommerce platform. Only consumers who agree to participate in the consumer study after reviewing the information provided and provide electronic Consent will be recruited.
Who may be able to join
- Aged 18 years or older
- Consumers who have purchased the product online
- Consumers who are willing to participate in the study
Who cannot join
- Female consumers who are pregnant or breast feeding
- Participants with Diabetes (Type I or II)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
RB Health
Hull, East Yorkshire, HU78DS
Stephen Fincham, MSc, 00441482582860, steve.fincham@rb.com
About this study
To evaluate the effect on quality of life of consumers with self-reported onychomycosis during the first 4 weeks of treatment in relation to the appearance of the infected toenail.
Read the detailed description
The appearance of the infected toe nail in those suffering from the disease may have a greater impact on quality of life than the severity of the disease. It is believed that a visual improvement in the appearance of the infected toenail at an earlier stage could have a positive impact on quality of life and encourage compliance with treatment. The aim of this consumer study is to evaluate the quality of life of consumers with onychomycosis and investigate its relation to the appearance of the infected toenail within the initial 4 weeks of treatment with Scholl Fungal Nail following its purchase from an eCommerce platform.
- Conditions
- Onychomycosis of Toenail
- Being tested
- Fungal Nail Treatment Kit
- Keywords
- Fungal Nail Infection, Internet Mediated Research Study
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fungal Nail Treatment KitDevice
The treatment kit consists of 5 disposable nail files to be used to remove the top layer of the infected nail at various times throughout the use of the product and a liquid formulation and brush applicator.
| Study group | Role | What they receive |
|---|---|---|
| Onychomycosis group | Subjects in this group suffer from onychomycosis of the toenail, who chose to self treat by purchasing the product from an online platform. Receives: Device: Fungal Nail Treatment Kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life Improvement
Change in mean total score of the OnyCOE-t™ from baseline to end of inital treatment period. The domains are transformed into 0-100 scale where higher scores indicate better functioning. Changes from baseline of the mean total score will be evaluated with repeated measures t-tests.
The questionnaire contains 7 domains:
7-item Toenail Symptoms, containing Symptom Frequency (5 categories: 1 = never, 5 = very often) and Symptom Bothersomeness (5 categories: 1 = not at all bothered, 5 = extremely bothered) 8-item Appearance Problems (4 categories: 1 = very much a problem, 4 = not a problem) 7-item Physical Activities Problems (4 categories: 1 = very much a problem, 4 = not a problem)
1-item Overall Problem (4 categories; 1 = very much a problem, 4 = not a problem) 7-item Stigma (5 categories: 0 = does not describe me at all, 4 = describes me very well) 3-item Treatment Satisfaction scale (5 categories: 1 = very satisfied, 5 very dissatisfied)
Measured: 28 days
Secondary outcomes (6)
Participant perception of the improvement in healthy appearance of their infected toenail.
The participants will be asked to score the statement "My toenail looks healthy" (prior to product use) and "My toenail looks healthier" (at various time points following product application) using the following categories, strongly agree, agree, neither agree nor disagree, disagree, Strongly disagree. A successful outcome of this measure would be 70% Top 2 Boxes (T2B) (Strongly Agree or Agree) improvement in the healthier appearance of the target toenail at any post baseline assessment compare to Day 1 (prior to initial product application)
Measured: Any timepoint up to day 28
Participant perception of improvement in brightness of their infected toenail.
The participants will be asked to score the statement "My toenail looks bright" (prior to product use) and "My toenail looks brighter" (at various time points following product application) using the following categories, strongly agree, agree, neither agree nor disagree, disagree, Strongly disagree. A successful outcome of this measure would be 70% T2B (Strongly Agree or Agree) improvement in the brighter appearance of the target toenail as determined by participant perceived questions at any post baseline assessment compare to Day 1 (prior to initial product application)
Measured: Any timepoint up to day 28
Participant perception of the improvement in colour of their infected toenail.
The participants will be asked to score the statement "My toenail is its natural colour" (prior to product use) and "My toenail is returning to its natural colour" (at various time points following product application) using the following categories, strongly agree, agree, neither agree nor disagree, disagree, Strongly disagree. A successful outcome of this measure would be 70% T2B (Strongly Agree or Agree) improvement in the colour of the target toenail as determined by participant perceived questions at any post baseline assessment compare to Day 1 (prior to initial product application)
Measured: Any timepoint up to day 28
Participant perception of the improvement in smoothness of their infected toenail.
The participants will be asked to score the statement "My toenail looks smooth" (prior to product use) and "My toenail looks smoother" (at various time points following product application) using the following categories, strongly agree, agree, neither agree nor disagree, disagree, Strongly disagree. A successful outcome of this measure would be 70% T2B (Strongly Agree or Agree) improvement in the smoothness of the target toenail as determined by participant perceived questions at any post baseline assessment compare to Day 1 (prior to initial product application)
Measured: Any timepoint up to day 28
Participant perception of improvement of their feelings of embarrassment associated with their infected toenail.
The participants will be asked to score the statement "I am feeling embarrassed by the appearance of my toenail" (prior to product use and at various time points following product application) using the following categories, strongly agree, agree, neither agree nor disagree, disagree, Strongly disagree. A successful outcome of this measure would be 70% of responses show improvement from baseline and are in the T2B (Strongly Disagree or Disagree) in the feelings of embarrassment relating to the appearance of the target toenail as determined by participant perceived questions at any post baseline assessment compared to Day 1 (prior to initial product application)
Measured: Any timepoint up to day 28
Individual OnyCOE-t(TM) domain improvement
Improvement in the mean scores on the individual OnyCOE-t(TM) domains (as detailed in outcome 1 above).
The data will be summarised with means, standard deviations, range and 95% confidence intervals, changes from baseline of the mean individual domain score will be evaluated using repeated measures t-tests.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start13 Aug 2019
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Onychomycosis of ToenailStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Reckitt Benckiser Healthcare (UK) Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Neil Fawkes, MBChB, Principal investigator, Reckitt Bencksier, Dansom Lane, Hull
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04084782
- Sponsor's protocol ID
- NPD89101
- Status last verified
- Sep 2019
- First submitted
- 9 Aug 2019
- Last updated
- 10 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study sponsor may author journal article outlining the collective results of the study, however IPD will not be shared.
Publications
Velasquez-Agudelo V, Cardona-Arias JA. Meta-analysis of the utility of culture, biopsy, and direct KOH examination for the diagnosis of onychomycosis. BMC Infect Dis. 2017 Feb 22;17(1):166. doi: 10.1186/s12879-017-2258-3.
PubMed 28222676Sigurgeirsson B, Ghannoum MA, Osman-Ponchet H, Kerrouche N, Sidou F. Application of cosmetic nail varnish does not affect the antifungal efficacy of amorolfine 5% nail lacquer in the treatment of distal subungual toenail onychomycosis: results of a randomised active-controlled study and in vitro assays. Mycoses. 2016 May;59(5):319-26. doi: 10.1111/myc.12473. Epub 2016 Feb 11.
PubMed 26867498Christenson JK, Peterson GM, Naunton M, Bushell M, Kosari S, Baby KE, Thomas J. Challenges and Opportunities in the Management of Onychomycosis. J Fungi (Basel). 2018 Jul 24;4(3):87. doi: 10.3390/jof4030087.
PubMed 30042327Tosti A, Elewski BE. Treatment of onychomycosis with efinaconazole 10% topical solution and quality of life. J Clin Aesthet Dermatol. 2014 Nov;7(11):25-30.
PubMed 25489379Potter LP, Mathias SD, Raut M, Kianifard F, Tavakkol A. The OnyCOE-t questionnaire: responsiveness and clinical meaningfulness of a patient-reported outcomes questionnaire for toenail onychomycosis. Health Qual Life Outcomes. 2006 Aug 15;4:50. doi: 10.1186/1477-7525-4-50.
PubMed 16911778Potter LP, Mathias SD, Raut M, Kianifard F, Landsman A, Tavakkol A. The impact of aggressive debridement used as an adjunct therapy with terbinafine on perceptions of patients undergoing treatment for toenail onychomycosis. J Dermatolog Treat. 2007;18(1):46-52. doi: 10.1080/09546630600965004.
PubMed 17373090
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Internet Mediated Research Study to Assess the Quality of Life of Consumers With Self-reported Fungal Nail Infection (Onychomycosis) During Treatment With Scholl Fungal Nail.
- ClinicalTrials.gov ID
- NCT04084782
- Acronym / sponsor ID
- NPD89101
- Conditions
- Onychomycosis of Toenail
- Keywords
- Fungal Nail Infection, Internet Mediated Research Study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Reckitt Benckiser Healthcare (UK) LimitedIndustry (pharma, biotech, devices)
- Study start
- 13 Aug 2019 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 10 Sep 2019 (actual)
- 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.
To evaluate the effect on quality of life of consumers with self-reported onychomycosis during the first 4 weeks of treatment in relation to the appearance of the infected toenail.
Detailed description
The appearance of the infected toe nail in those suffering from the disease may have a greater impact on quality of life than the severity of the disease. It is believed that a visual improvement in the appearance of the infected toenail at an earlier stage could have a positive impact on quality of life and encourage compliance with treatment. The aim of this consumer study is to evaluate the quality of life of consumers with onychomycosis and investigate its relation to the appearance of the infected toenail within the initial 4 weeks of treatment with Scholl Fungal Nail following its purchase from an eCommerce platform.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Onychomycosis group | – | Device: Fungal Nail Treatment KitSubjects in this group suffer from onychomycosis of the toenail, who chose to self treat by purchasing the product from an online platform. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study is targeting consumers who chose to self-treat by purchasing the Fungal Nail product from the eCommerce platform. Only consumers who agree to participate in the consumer study after reviewing the information provided and provide electronic Consent will be recruited.
Key inclusion criteria (3 listed)
- Aged 18 years or older
- Consumers who have purchased the product online
- Consumers who are willing to participate in the study
Key exclusion criteria (2 listed)
- Female consumers who are pregnant or breast feeding
- Participants with Diabetes (Type I or II)
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 |
|---|---|---|
| Fungal Nail Treatment KitThe treatment kit consists of 5 disposable nail files to be used to remove the top layer of the infected nail at various times throughout the use of the product and a liquid formulation and brush applicator. | Device | Onychomycosis group |
Primary outcome
Quality of Life Improvement
Time frame: 28 days
Change in mean total score of the OnyCOE-t™ from baseline to end of inital treatment period. The domains are transformed into 0-100 scale where higher scores indicate better functioning. Changes from baseline of the mean total score will be evaluated with repeated measures t-tests. The questionnaire contains 7 domains: 7-item Toenail Symptoms, containing Symptom Frequency (5 categories: 1 = never, 5 = very often) and Symptom Bothersomeness (5 categories: 1 = not at all bothered, 5 = extremely bothered) 8-item Appearance Problems (4 categories: 1 = very much a problem, 4 = not a problem) 7-item Physical Activities Problems (4 categories: 1 = very much a problem, 4 = not a problem) 1-item Overall Problem (4 categories; 1 = very much a problem, 4 = not a problem) 7-item Stigma (5 categories: 0 = does not describe me at all, 4 = describes me very well) 3-item Treatment Satisfaction scale (5 categories: 1 = very satisfied, 5 very dissatisfied)
6 secondary outcomes
Participant perception of the improvement in healthy appearance of their infected toenail.
Time frame: Any timepoint up to day 28
Participant perception of improvement in brightness of their infected toenail.
Time frame: Any timepoint up to day 28
Participant perception of the improvement in colour of their infected toenail.
Time frame: Any timepoint up to day 28
Participant perception of the improvement in smoothness of their infected toenail.
Time frame: Any timepoint up to day 28
Participant perception of improvement of their feelings of embarrassment associated with their infected toenail.
Time frame: Any timepoint up to day 28
Individual OnyCOE-t(TM) domain improvement
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2019.
- Background: PubMed 28222676Velasquez-Agudelo V, Cardona-Arias JA. Meta-analysis of the utility of culture, biopsy, and direct KOH examination for the diagnosis of onychomycosis. BMC Infect Dis. 2017 Feb 22;17(1):166. doi: 10.1186/s12879-017-2258-3.
- Background: PubMed 26867498Sigurgeirsson B, Ghannoum MA, Osman-Ponchet H, Kerrouche N, Sidou F. Application of cosmetic nail varnish does not affect the antifungal efficacy of amorolfine 5% nail lacquer in the treatment of distal subungual toenail onychomycosis: results of a randomised active-controlled study and in vitro assays. Mycoses. 2016 May;59(5):319-26. doi: 10.1111/myc.12473. Epub 2016 Feb 11.
- Background: PubMed 30042327Christenson JK, Peterson GM, Naunton M, Bushell M, Kosari S, Baby KE, Thomas J. Challenges and Opportunities in the Management of Onychomycosis. J Fungi (Basel). 2018 Jul 24;4(3):87. doi: 10.3390/jof4030087.
- Background: PubMed 25489379Tosti A, Elewski BE. Treatment of onychomycosis with efinaconazole 10% topical solution and quality of life. J Clin Aesthet Dermatol. 2014 Nov;7(11):25-30.
- Background: PubMed 16911778Potter LP, Mathias SD, Raut M, Kianifard F, Tavakkol A. The OnyCOE-t questionnaire: responsiveness and clinical meaningfulness of a patient-reported outcomes questionnaire for toenail onychomycosis. Health Qual Life Outcomes. 2006 Aug 15;4:50. doi: 10.1186/1477-7525-4-50.
- Background: PubMed 17373090Potter LP, Mathias SD, Raut M, Kianifard F, Landsman A, Tavakkol A. The impact of aggressive debridement used as an adjunct therapy with terbinafine on perceptions of patients undergoing treatment for toenail onychomycosis. J Dermatolog Treat. 2007;18(1):46-52. doi: 10.1080/09546630600965004.
- UK Research Integrity Office - Good Practice in research: internet mediated research V1.0 Dec 2016Link provided by the sponsor.
- Individual participant dataSharing planned: No. The study sponsor may author journal article outlining the collective results of the study, however IPD will not be shared.
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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.
Neil Fawkes, MBChB principal investigator
Reckitt Bencksier, Dansom Lane, Hull
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Onychomycosis of Toenail, 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 2 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: status not confirmed, as of the sponsor's last update on 10 Sep 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stephen Fincham, MSc (+44 1482326151, steve.fincham@rb.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life Improvement (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04084782, which also lists 6 linked publications.
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 10 Sep 2019.