Back to resultsA Clinical Investigation to Evaluate the Safety and Performance of a Treatment Kit for Ingrowing Toenail
Primary Purpose
Onychomycosis of Toenails
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Ingrowing Toenail Treatment Kit
Sponsored by
About this trial
This is an interventional treatment trial for Onychomycosis of Toenails
Eligibility 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.
Sites / Locations
- CPS Research Ltd.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ingrowing Toenail Treatment Kit
Arm Description
Ingrowing Toenail Treatment Kit consists of 3 components: Toe nail clip: one clip to be applied each week, for 6 weeks. Aerosol spray: to be applied up to 5 times a day, no more than one spray per hour. Nail adhesive: used to attach the clip to the nail.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02131363
First Posted
May 2, 2014
Last Updated
January 12, 2015
Sponsor
Reckitt Benckiser Healthcare (UK) Limited
1. Study Identification
Unique Protocol Identification Number
NCT02131363
Brief Title
A Clinical Investigation to Evaluate the Safety and Performance of a Treatment Kit for Ingrowing Toenail
Official Title
A Clinical Investigation to Evaluate the Safety and Performance of a Treatment Kit for Ingrowing Toenail
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Reckitt Benckiser Healthcare (UK) Limited
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Onychomycosis of Toenails
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ingrowing Toenail Treatment Kit
Arm Type
Experimental
Arm Description
Ingrowing Toenail Treatment Kit consists of 3 components:
Toe nail clip: one clip to be applied each week, for 6 weeks.
Aerosol spray: to be applied up to 5 times a day, no more than one spray per hour.
Nail adhesive: used to attach the clip to the nail.
Intervention Type
Device
Intervention Name(s)
Ingrowing Toenail Treatment Kit
Intervention Description
detailed in arm description
Primary Outcome Measure Information:
Title
The proportion of subjects who demonstrate a reduction in the severity of their ingrowing toenail
Description
This will be assessed by the Investigator, using the Investigator Ingrowing Toenail Severity Scale.
Time Frame
At Day 42 from Day 0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
CPS Research Ltd.
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G20 0XA
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Clinical Investigation to Evaluate the Safety and Performance of a Treatment Kit for Ingrowing Toenail
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