Evaluation of the Performance of a Fungal Nail Treatment on the Visual Signs of Onychomycosis

NCT02546258 | Completed

• 1 other identifier: NPD810
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, open label, non-comparative clinical investigation to evaluate the performance of a Fungal Nail Treatment on the visual signs of onychomycosis. The Fungal Nail Treatment is a CE Marked Class I Medical Device and is commercially available as an over-the-counter product. The ability of the Fungal Nail Treatment to treat the visual signs of mild fungal toenail infections will be determined by a reduction in the surface area of the infection over time. This will be assessed through visual quantification of the infected area from baseline, as measured by image analysis, throughout the treatment period, where subjects will follow instructions for use on the product pack and self-treat for the duration of the investigation or until their condition has resolved. Both subject and podiatrist will assess the improvement of signs and symptoms of the target nail.

Conditions

Onychomycosis of Toenails

Keywords

Fungal Nail

Outcome Measures

Primary Outcomes (1)

• Percentage reduction of the surface area of infection over time using image analysis

  40 weeks

Secondary Outcomes (2)

• Percentage reduction of the surface area of infection over time from baseline to week 4 using image analysis

  4 weeks

• The proportion of subjects whose fungal nail infection has resolved

  40 weeks

Study Arms (1)

A Funagl Nail Treatment

OTHER

Marketed treatment of Fungal Nail Follow instructions on pack

Device: A Fungal Nail Treatment

Interventions

A Fungal Nail Treatment DEVICE

treats the signs of mild fungal nail infections

Also known as: Funagl Nail Treatment

A Funagl Nail Treatment

Eligibility Criteria

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

You may qualify if:

• Informed consent has been obtained.
• Age between 18 years to 65 years inclusive.
• Gender: male and female subjects.
• Subjects with visual signs of MILD fungal nail infection present on at least one big toenail or with fungal nail infection on one other toenail on the same foot, in addition to the target big toenail (condition of other foot not relevant) as per podiatrist visual assessment.
• Subjects with no more than 50% surface area of the target big toenail visually affected, from the leading distal edge, as assessed by the podiatrist.

You may not qualify if:

• Subjects with moderate to severe fungal toenail infection, on either big toenail, as determined by podiatrist assessment.
• Subjects with fungal nail infection on more than two toenails on their target foot.
• Subjects reporting presence of visual symptoms of fungal toenail infection for more than five years.

Sponsors & Collaborators

• Reckitt Benckiser Healthcare (UK) Limited: lead
• Intertek: collaborator

Study Sites (1)

Intertek CRS

Manchester, United Kingdom

Location

Study Officials

• Rashid Haye, MBBS MD

  Intertek CRS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2015
• First Posted: September 10, 2015
• Study Start: August 25, 2014
• Primary Completion: November 21, 2014
• Study Completion: November 21, 2014
• Last Updated: April 11, 2017

Record last verified: 2015-11

Locations

GB (1)