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.

NCT04084782 | Unknown

• 1 other identifier: NPD89101
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Onychomycosis of Toenail

Keywords

Fungal Nail Infection; Internet Mediated Research Study

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Participant perception of the improvement in healthy appearance of their infected toenail.

  Any timepoint up to day 28

• Participant perception of improvement in brightness of their infected toenail.

  Any timepoint up to day 28

• Participant perception of the improvement in colour of their infected toenail.

  Any timepoint up to day 28

• Participant perception of the improvement in smoothness of their infected toenail.

  Any timepoint up to day 28

• Participant perception of improvement of their feelings of embarrassment associated with their infected toenail.

  Any timepoint up to day 28

Study Arms (1)

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.

Device: Fungal Nail Treatment Kit

Interventions

Fungal Nail Treatment Kit 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.

Onychomycosis group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Aged 18 years or older
• Consumers who have purchased the product online
• Consumers who are willing to participate in the study

You may not qualify if:

• Female consumers who are pregnant or breast feeding
• Participants with Diabetes (Type I or II)

Sponsors & Collaborators

• Reckitt Benckiser Healthcare (UK) Limited: lead

Study Sites (1)

RB Health

Hull, East Yorkshire, HU78DS, United Kingdom

RECRUITING

Related Publications (6)

• 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.

  PMID: 28222676 BACKGROUND

• 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.

  PMID: 26867498 BACKGROUND

• 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.

  PMID: 30042327 BACKGROUND

• 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.

  PMID: 25489379 BACKGROUND

• 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.

  PMID: 16911778 BACKGROUND

• 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.

  PMID: 17373090 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Onychomycosis

Condition Hierarchy (Ancestors)

Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Nail Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Neil Fawkes, MBChB

  Reckitt Bencksier, Dansom Lane, Hull

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephen Fincham, MSc

CONTACT

+44 1482326151; steve.fincham@rb.com

Carol Hegarty, PhD

CONTACT

+44 1482326151; carol.hegarty@rb.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2019
• First Posted: September 10, 2019
• Study Start: August 13, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: September 10, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)