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Completed

NCT Number: NCT02131363

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

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.

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Key information

Conditions

Onychomycosis of Toenails

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CPS Research Ltd.

Glasgow, Scotland, G20 0XA, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ingrowing Toenail Treatment Kit

Device

detailed in arm description

Primary outcomes

  1. The proportion of subjects who demonstrate a reduction in the severity of their ingrowing toenail

    Time frame: At Day 42 from Day 0

    This will be assessed by the Investigator, using the Investigator Ingrowing Toenail Severity Scale.

Sponsors and collaborators

Lead sponsor

Reckitt Benckiser Healthcare (UK) Limited

Industry

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
May 6, 2014
Registry last updated
Jan 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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