Clinical trial NCT04084782: 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.
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.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Onychomycosis of Toenail
Keywords: Fungal Nail Infection
Internet Mediated Research Study
Lead sponsor: Reckitt Benckiser Healthcare (UK) Limited
Sponsor class: INDUSTRY
First posted: 2019-09-10
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Quality of Life Improvement
timeFrame: 28 days
Secondary outcomes:
measure: Participant perception of the improvement in healthy appearance of their infected toenail.
timeFrame: Any timepoint up to day 28
measure: Participant perception of improvement in brightness of their infected toenail.
timeFrame: Any timepoint up to day 28
measure: Participant perception of the improvement in colour of their infected toenail.
timeFrame: Any timepoint up to day 28
measure: Participant perception of the improvement in smoothness of their infected toenail.
timeFrame: Any timepoint up to day 28
measure: Participant perception of improvement of their feelings of embarrassment associated with their infected toenail.
timeFrame: Any timepoint up to day 28
measure: Individual OnyCOE-t(TM) domain improvement
timeFrame: 28 days
Other outcomes:
Locations:
city: Hull
country: United Kingdom
facility: RB Health
state: East Yorkshire
Study officials:
affiliation: Reckitt Bencksier, Dansom Lane, Hull
name: Neil Fawkes, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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):87. doi: 10.3390/jof4030087.
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.
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. doi: 10.1186/1477-7525-4-50.
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. doi: 10.1080/09546630600965004.