An interventional study of Terbinafine and Q-switched Nd:YAG laser in Onychomycosis, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by Assiut University · Not applicable, Interventional, and Treatment
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.
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.
147 studies on the registry are indexed under Onychomycosis; 13 are open to participants now.
This study's planned enrollment of 97 is above the median of 56 across 134 interventional studies indexed under Onychomycosis.
Browse Onychomycosis studies →Assiut University is the lead sponsor of 4,919 studies on the registry; 2,116 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Oral terbinafine 250 mg daily plus Q-switched Nd:YAG laser sessions every 2 weeks for 6 sessions.
Drug: Terbinafine · Device: Q-switched Nd:YAG laser
Oral terbinafine 250 mg daily without laser therapy.
Drug: Terbinafine
Oral terbinafine 250 mg once daily for 6 weeks (fingernails) or 12 weeks (toenails).
Q-switched Nd:YAG laser (1064 nm) applied to the affected nail plate, 4 passes per session, every 2 weeks for 6 sessions.
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.
Time frame: At 3 months
Mycological cure rate
Number of patients with negative direct microscopy and negative fungal culture at the end of treatment.
Time frame: At 3 months
Clinical cure rate
Number of patients achieving complete or near-complete normalization of the treated nail appearance.
Time frame: At 3 months
Patient satisfaction score
Mean patient satisfaction score using a quartile grading system (0 = unsatisfied to 3 = very satisfied).
Time frame: At 3 months
Number of patients with treatment-related adverse events
Number of patients who experience any treatment-related adverse events.
Time frame: At 3 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Assiut University