Systemic Antifungal Plus Q-Switched Nd:YAG Laser for Onychomycosis

NCT07869706 — Not applicable, Not yet recruiting, 97 participants, Assiut University

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Systemic Antifungal Therapy Combined With Q-Switched Nd:YAG Laser Versus Systemic Antifungal Therapy Alone in the Treatment of Onychomycosis

Registry	NCT07869706
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	97 (Estimated)
Sponsor	Assiut University (Other)
Conditions	Onychomycosis
Interventions	Terbinafine, Q-switched Nd:YAG laser (Drug, device)
Dates	start 2026-10-10 (estimated), primary completion 2027-10-10 (estimated), completion 2028-02-10 (estimated), first posted 2026-10-09, last updated 2026-10-09

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Terbinafine plus Q-switched Nd:YAG laser	Experimental	Drug: Terbinafine; Device: Q-switched Nd:YAG laser	Oral terbinafine 250 mg daily plus Q-switched Nd:YAG laser sessions every 2 weeks for 6 sessions.
Terbinafine alone	Active comparator	Drug: Terbinafine	Oral terbinafine 250 mg daily without laser therapy.

Terbinafine (Drug): Oral terbinafine 250 mg once daily for 6 weeks (fingernails) or 12 weeks (toenails).
Q-switched Nd:YAG laser (Device): Q-switched Nd:YAG laser (1064 nm) applied to the affected nail plate, 4 passes per session, every 2 weeks for 6 sessions.

+Outcome measures

Primary outcomes

Change in Onychomycosis Severity Index [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.

Secondary outcomes

Mycological cure rate [At 3 months]: Number of patients with negative direct microscopy and negative fungal culture at the end of treatment.
Clinical cure rate [At 3 months]: Number of patients achieving complete or near-complete normalization of the treated nail appearance.
Patient satisfaction score [At 3 months]: Mean patient satisfaction score using a quartile grading system (0 = unsatisfied to 3 = very satisfied).
Number of patients with treatment-related adverse events [At 3 months]: Number of patients who experience any treatment-related adverse events.

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* \- 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

Exclusion Criteria:

* \- 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
* 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

+Investigators

Sahar A Ahmed, prof, Study chair, Dermatology Department, Assiut University Hospitals