Radiofrequency in Onychomycosis

May 24, 2022 updated by: Hagar El Sayed, Cairo University

Non Ablative Radiofrequency in the Treatment of Onychomycosis, a Pilot Study

Onychomycosis is the most common nail disease, representing more than 50% of all onychopathies.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Onychomycosis patients

Exclusion Criteria:

Patients with excessive manual work

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Non ablative radiofrequency
Device
Device: Non ablative radiofrequency
Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Onychomycosis severity index
Time Frame: 3 months
Clinical assessment
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2022

Primary Completion (Anticipated)

October 1, 2022

Study Completion (Anticipated)

October 1, 2022

Study Registration Dates

First Submitted

May 20, 2022

First Submitted That Met QC Criteria

May 24, 2022

First Posted (Actual)

May 25, 2022

Study Record Updates

Last Update Posted (Actual)

May 25, 2022

Last Update Submitted That Met QC Criteria

May 24, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Onychomycosis

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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