OnychomycosisNCT05390190
Radiofrequency in Onychomycosis
A study testing Non ablative radiofrequency in people with Onychomycosis, run by Cairo University.
Trial summary
Onychomycosis is the most common nail disease, representing more than 50% of all onychopathies. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Onychomycosis
- What is being tested?
- Non ablative radiofrequency
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2022to 1 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Onychomycosis patients
Who cannot join
- Patients with excessive manual work
About this study
Official title: 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.
Read the 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.
- Conditions
- Onychomycosis
- Being tested
- Non ablative radiofrequency
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non ablative radiofrequencyDevice
Device
| Study group | Role | What they receive |
|---|---|---|
| Non ablative radiofrequency | Experimental | Device Receives: Device: Non ablative radiofrequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
Onychomycosis severity index
Clinical assessment
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start1 Jul 2022 (estimated)
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OnychomycosisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hagar El Sayed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05390190
- Sponsor's protocol ID
- onychomycosis
- Status last verified
- May 2022
- First submitted
- 20 May 2022
- Last updated
- 25 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non Ablative Radiofrequency in the Treatment of Onychomycosis, a Pilot Study
- ClinicalTrials.gov ID
- NCT05390190
- Acronym / sponsor ID
- onychomycosis
- Conditions
- Onychomycosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 25 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non ablative radiofrequency | Experimental | Device: Non ablative radiofrequencyDevice |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Onychomycosis patients
Key exclusion criteria (1 listed)
- Patients with excessive manual work
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non ablative radiofrequencyDevice | Device | Non ablative radiofrequency |
Primary outcome
Onychomycosis severity index
Time frame: 3 months
Clinical assessment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Non ablative radiofrequency in people with Onychomycosis, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Onychomycosis severity index (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2022.