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

This study has been completed.
Information provided by (Responsible Party):
Reckitt Benckiser Healthcare (UK) Limited Identifier:
First received: May 2, 2014
Last updated: January 12, 2015
Last verified: September 2014
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.

Condition Intervention
Onychomycosis of Toenails
Device: Ingrowing Toenail Treatment Kit

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Clinical Investigation to Evaluate the Safety and Performance of a Treatment Kit for Ingrowing Toenail

Further study details as provided by Reckitt Benckiser Healthcare (UK) Limited:

Primary Outcome Measures:
  • 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.

Enrollment: 36
Study Start Date: August 2014
Study Completion Date: December 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Device: Ingrowing Toenail Treatment Kit
detailed in arm description


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT02131363

United Kingdom
CPS Research Ltd.
Glasgow, Scotland, United Kingdom, G20 0XA
Sponsors and Collaborators
Reckitt Benckiser Healthcare (UK) Limited
  More Information

Responsible Party: Reckitt Benckiser Healthcare (UK) Limited Identifier: NCT02131363     History of Changes
Other Study ID Numbers: NPD21402
Study First Received: May 2, 2014
Last Updated: January 12, 2015

Additional relevant MeSH terms:
Nails, Ingrown
Skin Diseases, Infectious
Nail Diseases
Skin Diseases processed this record on May 25, 2017