OnychomycosisNCT07869706
Systemic Antifungal Plus Q-Switched Nd:YAG Laser for Onychomycosis
A study testing Terbinafine and Q-switched Nd:YAG laser in people with Onychomycosis, run by Assiut University.
Trial summary
This randomized controlled trial aims to compare the efficacy and safety of systemic terbinafine combined with Q-switched Nd:YAG laser versus systemic terbinafine alone in the treatment of onychomycosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Onychomycosis
- What is being tested?
- Terbinafine and Q-switched Nd:YAG laser
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- No sites listed yet
- Study dates
- 10 Oct 2026to 10 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - Age 18 years or older
- Mycologically confirmed onychomycosis by direct microscopy with potassium hydroxide and/or fungal culture
- Willing to receive systemic antifungal therapy
- Willing to undergo Q-switched Nd:YAG laser treatment
- Written informed consent
Who cannot join
- - Pregnancy or lactation
- Planned pregnancy during treatment
- Nail disorders such as psoriasis, eczema, or lichen planus
- Significant hepatic disease
- Significant renal impairment
- Congestive heart failure or ventricular dysfunction
Show all 10Show fewer
- Previous systemic antifungal therapy within the preceding 3 months
- Previous topical antifungal therapy of the target nail within the preceding 1 month
- Previous laser treatment of the target nail
- Clinically significant drug interaction with systemic antifungal agents
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Systemic Antifungal Therapy Combined With Q-Switched Nd:YAG Laser Versus Systemic Antifungal Therapy Alone in the Treatment of Onychomycosis
This randomized controlled trial aims to compare the efficacy and safety of systemic terbinafine combined with Q-switched Nd:YAG laser versus systemic terbinafine alone in the treatment of onychomycosis.
Read the detailed description
Onychomycosis is a common fungal infection of the nails. Systemic antifungal therapy is the standard treatment for moderate-to-severe disease, and Q-switched Nd:YAG laser has been investigated as an adjunctive modality.
This prospective randomized trial will compare clinical and mycological outcomes between patients receiving oral terbinafine alone and those receiving oral terbinafine combined with Q-switched Nd:YAG laser therapy.
- Conditions
- Onychomycosis
- Being tested
- Terbinafine, Q-switched Nd:YAG laser
- Keywords
- Terbinafine, Onychomycosis, Q-switched Nd:YAG laser, Assiut, Nail fungus
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TerbinafineDrug
Oral terbinafine 250 mg once daily for 6 weeks (fingernails) or 12 weeks (toenails).
Q-switched Nd:YAG laserDevice
Q-switched Nd:YAG laser (1064 nm) applied to the affected nail plate, 4 passes per session, every 2 weeks for 6 sessions.
| Study group | Role | What they receive |
|---|---|---|
| Terbinafine plus Q-switched Nd:YAG laser | Experimental | Oral terbinafine 250 mg daily plus Q-switched Nd:YAG laser sessions every 2 weeks for 6 sessions. Receives: Drug: Terbinafine; Device: Q-switched Nd:YAG laser |
| Terbinafine alone | Active comparator | Oral terbinafine 250 mg daily without laser therapy. Receives: Drug: Terbinafine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Onychomycosis Severity Index
Mean change in Onychomycosis Severity Index (OSI) score (range 0 to 35, higher scores indicate more severe disease) from baseline to end of treatment.
Measured: At 3 months
Secondary outcomes (4)
Mycological cure rate
Number of patients with negative direct microscopy and negative fungal culture at the end of treatment.
Measured: At 3 months
Clinical cure rate
Number of patients achieving complete or near-complete normalization of the treated nail appearance.
Measured: At 3 months
Patient satisfaction score
Mean patient satisfaction score using a quartile grading system (0 = unsatisfied to 3 = very satisfied).
Measured: At 3 months
Number of patients with treatment-related adverse events
Number of patients who experience any treatment-related adverse events.
Measured: 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 posted9 Oct 2026
- Study start10 Oct 2026 (estimated)
- Primary completion10 Oct 2027 (estimated)
- Study completion10 Feb 2028 (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 Assiut 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
- None (open label)
- Enrolment
- 97 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hala Ahmed Farghly Abd Elwahed, Assiut University
- Investigators
- Sahar A Ahmed, prof, Study chair, Dermatology Department, Assiut University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07869706
- Sponsor's protocol ID
- Onychomycosis-Laser-Assiut
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Antifungal Therapy Combined With Q-Switched Nd:YAG Laser Versus Systemic Antifungal Therapy Alone in the Treatment of Onychomycosis
- ClinicalTrials.gov ID
- NCT07869706
- Acronym / sponsor ID
- Onychomycosis-Laser-Assiut
- Conditions
- Onychomycosis
- Keywords
- Terbinafine, Onychomycosis, Q-switched Nd:YAG laser, Assiut, Nail fungus
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 97 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Oct 2026 (estimated)
- Primary completion
- 10 Oct 2027 (estimated)
- Study completion
- 10 Feb 2028 (estimated)
- First posted
- 9 Oct 2026 (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.
This randomized controlled trial aims to compare the efficacy and safety of systemic terbinafine combined with Q-switched Nd:YAG laser versus systemic terbinafine alone in the treatment of onychomycosis.
Detailed description
Onychomycosis is a common fungal infection of the nails. Systemic antifungal therapy is the standard treatment for moderate-to-severe disease, and Q-switched Nd:YAG laser has been investigated as an adjunctive modality.
This prospective randomized trial will compare clinical and mycological outcomes between patients receiving oral terbinafine alone and those receiving oral terbinafine combined with Q-switched Nd:YAG laser therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Terbinafine plus Q-switched Nd:YAG laser | Experimental | Drug: Terbinafine, Device: Q-switched Nd:YAG laserOral terbinafine 250 mg daily plus Q-switched Nd:YAG laser sessions every 2 weeks for 6 sessions. |
| Terbinafine alone | Active comparator | Drug: TerbinafineOral terbinafine 250 mg daily without laser therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- - Age 18 years or older
- Mycologically confirmed onychomycosis by direct microscopy with potassium hydroxide and/or fungal culture
- Willing to receive systemic antifungal therapy
- Willing to undergo Q-switched Nd:YAG laser treatment
- Written informed consent
Key exclusion criteria (10 listed)
- - Pregnancy or lactation
- Planned pregnancy during treatment
- Nail disorders such as psoriasis, eczema, or lichen planus
- Significant hepatic disease
- Significant renal impairment
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 |
|---|---|---|
| TerbinafineOral terbinafine 250 mg once daily for 6 weeks (fingernails) or 12 weeks (toenails). | Drug | Terbinafine alone, Terbinafine plus Q-switched Nd:YAG laser |
| Q-switched Nd:YAG laserQ-switched Nd:YAG laser (1064 nm) applied to the affected nail plate, 4 passes per session, every 2 weeks for 6 sessions. | Device | Terbinafine plus Q-switched Nd:YAG laser |
Primary outcome
Change in Onychomycosis Severity Index
Time frame: At 3 months
Mean change in Onychomycosis Severity Index (OSI) score (range 0 to 35, higher scores indicate more severe disease) from baseline to end of treatment.
4 secondary outcomes
Mycological cure rate
Time frame: At 3 months
Clinical cure rate
Time frame: At 3 months
Patient satisfaction score
Time frame: At 3 months
Number of patients with treatment-related adverse events
Time frame: At 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Sahar A Ahmed, prof study chair
Dermatology Department, Assiut University Hospitals
Questions about this trial
What is this clinical trial studying?
A study testing Terbinafine and Q-switched Nd:YAG laser in people with Onychomycosis, run by Assiut 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 5 inclusion and 10 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: opening soon, as of the sponsor's last update on 9 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hala A Farghaly (01159003770, farghalyhala805@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Onychomycosis Severity Index (time frame: 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 9 Oct 2026.