Onychomycosis of Toenails
Conditions
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.
Interventions
DEVICEIngrowing Toenail Treatment Kit
detailed in arm description
Sponsors
Reckitt Benckiser Healthcare (UK) Limited
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of subjects who demonstrate a reduction in the severity of their ingrowing toenail | At Day 42 from Day 0 | This will be assessed by the Investigator, using the Investigator Ingrowing Toenail Severity Scale. |
Countries
United Kingdom
Outcome results
None listed