Pulse versus continuous terbinafine for onychomycosis: a randomized, double-blind, controlled trial

Area of Science:

• Dermatology
• Pharmacology
• Clinical Trials

Background:

• Onychomycosis treatments can be costly.
• Pulsed-dose antifungal regimens are explored as a less expensive alternative to continuous dosing.
• Terbinafine is a primary treatment for toenail onychomycosis.

Purpose of the Study:

• To compare the efficacy of pulse-dose terbinafine versus standard continuous-dose terbinafine for toenail onychomycosis.
• To determine if pulse-dose terbinafine is noninferior to continuous-dose terbinafine.

Main Methods:

• A double-blind, randomized, noninferiority clinical trial was conducted.
• Participants received either continuous terbinafine (250 mg daily for 3 months) or pulse terbinafine (500 mg daily for 1 week/month for 3 months).
• Primary outcome was mycological cure of the target toenail at 18 months; secondary outcomes included clinical and complete cure.

Main Results:

• Continuous-dose terbinafine demonstrated superiority over pulse-dose therapy for mycological cure (70.9% vs 58.7%) and clinical cure (44.6% vs 29.3%) of the target toenail.
• Complete cure of the target toenail and all 10 toenails was significantly higher with continuous dosing.
• The study did not meet its noninferiority criterion for pulse-dose terbinafine.

Conclusions:

• Continuous-dose terbinafine is more effective than pulse-dose terbinafine for treating toenail onychomycosis.
• The effectiveness of terbinafine therapy, particularly for complete cure of all toenails, was lower than previously anticipated.
• The study population comprised older men with severe onychomycosis.