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Terbinafine Hydrochloride 1% Iontophoresis for the Treatment of Toenail Onychomycosis: A Randomized Placebo Controlled Study

Ahmed Fathy Samhan and Nermeen Mohamed Abdelhalim

Background: Successful topical treatment with deep penetration of toenail onychomychosis remains hard as the delivery of effective degrees of antifungal drug to the site of action is very difficult.

Purpose: To evaluate the efficacy and safety of terbinafine hydrochloride 1% iontophoresis for treatment of toenail onychomychosis.

Methods: Forty patients (23 male and 17 female) with mean age 46.15 ± 7.72 and with mild-to-moderate toenail onychomycosis of the big toe, were enrolled in a randomized placebo controlled study. All patients were assigned randomly into two groups of equal number: study group received terbinafine hydrochloride 1% iontophoresis on the big toenail onychomycosis with an intensity of 3 to 4 mA/min for 30 minutes, 3 times per week for 4 weeks (12 sessions) and control group received placebo terbinafine hydrochloride 1% iontophoresis. Onychomychosis Severity Index, potassium hydroxide microscopy of a dermatophyte, and visual analogue scale for patient-reported pain during walking wearing shoes had been collected pre-treatment and post-treatment.

Results: Showed significant improvement in the 3 outcomes in study group (p<0.05) with non-significant improvement in control group (p>0.05). Moreover the analysis between the two groups showed highly significant improvement as the study group would be preferred.

Conclusion: Terbinafine hydrochloride 1% iontophoresis with an intensity of 3 to 4 mA/min appeared to be effective and safe for treatment of mild-to-moderate toenail onychomychosis after 4 weeks of treatment.