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.

NCT ID: NCT04084782

Last Updated: 2019-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-13

Study Completion Date

2019-12-31

Brief Summary

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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

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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

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Onychomycosis of Toenail

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Fungal Nail Treatment Kit

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Reckitt Benckiser Healthcare (UK) Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Neil Fawkes, MBChB

Role: PRINCIPAL_INVESTIGATOR

Reckitt Bencksier, Dansom Lane, Hull

Locations

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RB Health

Hull, East Yorkshire, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Stephen Fincham, MSc

Role: CONTACT

+44 1482326151

Carol Hegarty, PhD

Role: CONTACT

+44 1482326151

Facility Contacts

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Stephen Fincham, MSc

Role: primary

00441482582860

References

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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.

Reference Type BACKGROUND
PMID: 28222676 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26867498 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30042327 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25489379 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16911778 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17373090 (View on PubMed)

Related Links

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https://ukrio.org/wp-content/uploads/UKRIO-Guidance-Note-Internet-Mediated-Research-v1.0.pdf

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

Other Identifiers

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NPD89101

Identifier Type: -

Identifier Source: org_study_id

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