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

Onychomycosis of Toenails Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02131363
• Other study ID #: NPD21402
• Status: Completed
• Phase: N/A
• First received: May 2, 2014
• Last updated: January 12, 2015
• Start date: August 2014
• Est. completion date: December 2014

Study information

• Verified date: September 2014
• Source: Reckitt Benckiser Healthcare (UK) Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nails, Ingrown
• Onychomycosis
• Onychomycosis of Toenails

Intervention

Device:
• Ingrowing Toenail Treatment Kit
detailed in arm description

Locations

Country	Name	City	State
United Kingdom	CPS Research Ltd.	Glasgow	Scotland

Sponsors (1)

Lead Sponsor	Collaborator
Reckitt Benckiser Healthcare (UK) Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of subjects who demonstrate a reduction in the severity of their ingrowing toenail	This will be assessed by the Investigator, using the Investigator Ingrowing Toenail Severity Scale.	At Day 42 from Day 0	No