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.

Onychomycosis of Toenail Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04084782
• Other study ID #: NPD89101
• Status: Recruiting
• Start date: August 13, 2019
• Est. completion date: December 2019

Study information

• Verified date: September 2019
• Source: Reckitt Benckiser Healthcare (UK) Limited
• Contact: Stephen Fincham, MSc
• Phone: +44 1482326151
• Email: steve.fincham[@]rb.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Aged 18 years or older

• Consumers who have purchased the product online

• Consumers who are willing to participate in the study

Exclusion Criteria:

• Female consumers who are pregnant or breast feeding

• Participants with Diabetes (Type I or II)

Related Conditions & MeSH terms

• Infection
• Onychomycosis
• Onychomycosis of Toenail

Intervention

Device:
• Fungal Nail Treatment Kit
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.

Locations

Country	Name	City	State
United Kingdom	RB Health	Hull	East Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
Reckitt Benckiser Healthcare (UK) Limited

Country where clinical trial is conducted

United Kingdom, 

References & Publications (6)

Christenson 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). pii: E87. doi: 10.3390/jof4030087. Review. — View Citation

Potter 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. — View Citation

Potter 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. — View Citation

Sigurgeirsson 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. — View Citation

Tosti 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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	28 days
Secondary	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)	Any timepoint up to day 28
Secondary	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)	Any timepoint up to day 28
Secondary	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)	Any timepoint up to day 28
Secondary	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)	Any timepoint up to day 28
Secondary	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)	Any timepoint up to day 28
Secondary	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.	28 days

External Links

•   UK Research Integrity Office - Good Practice in research: internet mediated research V1.0 Dec 2016