Radiofrequency in Onychomycosis
Primary Purpose
Onychomycosis
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Non ablative radiofrequency
Sponsored by
About this trial
This is an interventional treatment trial for Onychomycosis
Eligibility Criteria
Inclusion Criteria:
- Onychomycosis patients
Exclusion Criteria:
Patients with excessive manual work
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Non ablative radiofrequency
Arm Description
Device
Outcomes
Primary Outcome Measures
Onychomycosis severity index
Clinical assessment
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05390190
Brief Title
Radiofrequency in Onychomycosis
Official Title
Non Ablative Radiofrequency in the Treatment of Onychomycosis, a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2022 (Anticipated)
Primary Completion Date
October 1, 2022 (Anticipated)
Study Completion Date
October 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Onychomycosis is the most common nail disease, representing more than 50% of all onychopathies.
Detailed Description
Treatments with antifungals may not be successful due to several factors, including the long time required to apply topical medications, the side effects of systemic drugs, and the application of insufficient medication to the target area. Non-ablative radiofrequency devices can be used to treat onychomycosis without harming the nail matrix cells.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Onychomycosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Non ablative radiofrequency
Arm Type
Experimental
Arm Description
Device
Intervention Type
Device
Intervention Name(s)
Non ablative radiofrequency
Intervention Description
Device
Primary Outcome Measure Information:
Title
Onychomycosis severity index
Description
Clinical assessment
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Onychomycosis patients
Exclusion Criteria:
Patients with excessive manual work
12. IPD Sharing Statement
Learn more about this trial
Radiofrequency in Onychomycosis
We'll reach out to this number within 24 hrs