Onychomycosis
Conditions
Keywords
Terbinafine, Onychomycosis, Q-switched Nd:YAG laser, Assiut, Nail fungus
Brief 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.
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.
Interventions
DRUGTerbinafine
Oral terbinafine 250 mg once daily for 6 weeks (fingernails) or 12 weeks (toenails).
DEVICEQ-switched Nd:YAG laser
Q-switched Nd:YAG laser (1064 nm) applied to the affected nail plate, 4 passes per session, every 2 weeks for 6 sessions.
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Contacts
CONTACTHala A Farghaly
STUDY_CHAIRSahar A Ahmed, prof
Dermatology Department, Assiut University Hospitals
Outcome results
None listed