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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Reckitt Benckiser Healthcare (UK) Limited
Sponsor:
Information provided by (Responsible Party):
Reckitt Benckiser Healthcare (UK) Limited
ClinicalTrials.gov Identifier:
NCT02131363
First received: May 2, 2014
Last updated: September 11, 2014
Last verified: September 2014
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]
    This will be assessed by the Investigator, using the Investigator Ingrowing Toenail Severity Scale.


Estimated Enrollment: 36
Study Start Date: August 2014
Estimated Study Completion Date: December 2014
Estimated 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02131363

Contacts
Contact: Nina Savania, BSc (Hons) +44 (0)1482 582193 nina.savania@rb.com

Locations
United Kingdom
CPS Research Ltd. Recruiting
Glasgow, Scotland, United Kingdom, G20 0XA
Principal Investigator: Alan G Wade, MB ChB FRCA         
Sponsors and Collaborators
Reckitt Benckiser Healthcare (UK) Limited
  More Information

No publications provided

Responsible Party: Reckitt Benckiser Healthcare (UK) Limited
ClinicalTrials.gov Identifier: NCT02131363     History of Changes
Other Study ID Numbers: NPD21402
Study First Received: May 2, 2014
Last Updated: September 11, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Onychomycosis
Nails, Ingrown
Tinea
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Nail Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 16, 2014