Radiofrequency in Onychomycosis | NCT05390190

Studies
Radiofrequency in Onychomycosis

NCT05390190

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

May 25, 2022Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Onychomycosis

Interventions

Non ablative radiofrequency

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2022Estimated

Primary Completion Date

Oct 1, 2022Estimated

Completion Date

Oct 1, 2022Estimated

First Submitted Date

May 20, 2022

First Submission Date that Met QC Criteria

May 24, 2022

First Posted Date

May 25, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 24, 2022

Last Update Posted Date

May 25, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Non ablative radiofrequency	Experimental	Device	Device: Non ablative radiofrequency

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Non ablative radiofrequency	Device	Device	Non ablative radiofrequency

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Onychomycosis severity index	Clinical assessment	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Onychomycosis patients

Exclusion Criteria:

Patients with excessive manual work

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014009	Onychomycosis

Ancestor Terms

ID	Term
D014005	Tinea
D003881	Dermatomycoses
D009181	Mycoses
D001423	Bacterial Infections and Mycoses

Browse Leaves

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Browse Branches

Not provided