A Clinical Investigation to Evaluate the Safety and Performance of a Treatment Kit for Ingrowing Toenail

NCT ID: NCT02131363

Last Updated: 2015-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2014-12-31

Brief Summary

This purpose of this study is to evaluate the safety and performance of a treatment kit for ingrowing toenail, primarily by determining the number of subjects who show a reduction in the severity of their ingrowing toenail.

Conditions

Onychomycosis of Toenails

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ingrowing Toenail Treatment Kit

Ingrowing Toenail Treatment Kit consists of 3 components:

1. Toe nail clip: one clip to be applied each week, for 6 weeks.

2. Aerosol spray: to be applied up to 5 times a day, no more than one spray per hour.

3. Nail adhesive: used to attach the clip to the nail.

Group Type: EXPERIMENTAL

Ingrowing Toenail Treatment Kit

Intervention Type: DEVICE

detailed in arm description

Interventions

Ingrowing Toenail Treatment Kit

detailed in arm description

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Subjects with one great ingrowing toenail that is rated as either "slightly ingrowing", "somewhat ingrowing" or "very ingrowing" on the Investigators Ingrowing Toenail Severity Scale.
• Subjects whose worst pain experienced in the week preceding inclusion, is rated at least 3 on the 10 point Subject Pain Intensity Scale.
• Subjects whose affected toenail has a minimum of 2mm distal edge and a minimum nail width of at least 16mm.

Exclusion Criteria

• Subjects with any other toenail pathology (including pincer and spicule toenail) that would compromise the fitting of the toenail clip, or its use.
• Subjects suspected to be immunocompromised.
• Subjects who suffer from impaired feeling in the feet due to diabetes, peripheral vascular disease or neuropathy.
• Subjects with any cutaneous pathology or cuts/abrasions which, in the opinion of the investigator, could compromise safety or affect the outcome of the clinical investigation (for example, interfere with assessments).
• Subjects with known sensitivity/allergies to any component of the investigational device.
• Significant current or past medical history of hepatic, renal, cardiac, pulmonary, digestive, haematological, neurological, locomotor or psychiatric disease, which, in the opinion of the Investigator, would compromise the safety of the subject or affect the outcome of the clinical investigation (as determined from self-reported medical history questionnaire).
• Use of concomitant medication likely to affect the response to the investigational device or confuse the results of the clinical investigation. Regular pain relief is not permitted and subjects must not take any analgesics in the 24 hours preceding any clinic visit.
• Female subjects of childbearing potential who, for the duration of the study, are either unwilling or unable to take adequate contraceptive precautions or are unwilling to be sexually abstinent.
• Pregnancy or lactating mother.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Reckitt Benckiser Healthcare (UK) Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CPS Research Ltd.

Glasgow, Scotland, United Kingdom

Countries

United Kingdom

Other Identifiers

NPD21402

Identifier Type: -

Identifier Source: org_study_id