OnychomycosisNCT05415852
Lasers in Onychomycosis
A study testing Laser in people with Onychomycosis, run by Cairo University.
Trial summary
Onychomycosis is the most common nail disease, representing more than 50% of all onychopathies. Future studies on the absorption spectra of dermatophyte fungi will be needed to develop lasers that effectively exploit absorption differences in fungi and dermal tissue. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Onychomycosis
- What is being tested?
- Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 25 Jun 2022to 15 Sep 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
- Patients with onychomycosis.
Who cannot join
- Patients with excessive manual work
About this study
Official title: Comparison Between Different Types of LASER in the Treatment of Onychomycosis, a Randomized Controlled Trial
Onychomycosis is the most common nail disease, representing more than 50% of all onychopathies. Future studies on the absorption spectra of dermatophyte fungi will be needed to develop lasers that effectively exploit absorption differences in fungi and dermal tissue.
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. Even with adequate systemic or topical therapy, the persistence of fungal infections is not uncommon. In light of these limitations, laser therapy has been proposed as an alternative option for onychomycosis therapy.
- Conditions
- Onychomycosis
- Being tested
- Laser
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaserDevice
Laser
| Study group | Role | What they receive |
|---|---|---|
| fractional CO2 laser | Active comparator | Laser Receives: Device: Laser |
| Pulsed dye laser | Active comparator | Laser Receives: Device: Laser |
| Nd Yag | Active comparator | Laser Receives: Device: Laser |
| Q switched Nd Yag | Active comparator | Laser Receives: Device: Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Onychomycosis severity index
clinical assessment
Measured: change from baseline at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start25 Jun 2022 (estimated)
- Primary completion15 Sep 2022 (estimated)
- Study completion15 Sep 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 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
- NCT05415852
- Sponsor's protocol ID
- Lasers in onychomycosis
- Status last verified
- Jun 2022
- First submitted
- 20 May 2022
- Last updated
- 13 Jun 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 13 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Different Types of LASER in the Treatment of Onychomycosis, a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05415852
- Acronym / sponsor ID
- Lasers in onychomycosis
- Conditions
- Onychomycosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 25 Jun 2022 (estimated)
- Primary completion
- 15 Sep 2022 (estimated)
- Study completion
- 15 Sep 2022 (estimated)
- First posted
- 13 Jun 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. Future studies on the absorption spectra of dermatophyte fungi will be needed to develop lasers that effectively exploit absorption differences in fungi and dermal tissue.
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. Even with adequate systemic or topical therapy, the persistence of fungal infections is not uncommon. In light of these limitations, laser therapy has been proposed as an alternative option for onychomycosis therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| fractional CO2 laser | Active comparator | Device: LaserLaser |
| Pulsed dye laser | Active comparator | Device: LaserLaser |
| Nd Yag | Active comparator | Device: LaserLaser |
| Q switched Nd Yag | Active comparator | Device: LaserLaser |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with onychomycosis.
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 |
|---|---|---|
| LaserLaser | Device | Nd Yag, Pulsed dye laser, Q switched Nd Yag, fractional CO2 laser |
Primary outcome
Onychomycosis severity index
Time frame: change from baseline at 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 13 Jun 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 Laser 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 13 Jun 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: change from baseline at 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 13 Jun 2022.