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Radiofrequency in Onychomycosis

Primary Purpose

Onychomycosis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Non ablative radiofrequency
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Onychomycosis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    May 20, 2022
    Last Updated
    May 24, 2022
    Sponsor
    Cairo University
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    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

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    Radiofrequency in Onychomycosis

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