New Topical Therapies for Onychomycosis
For more than 15 years the only available topical therapy for onychomycosis was ciclopirox, which offered rather low cure rates. In 2014 two new topical agents were approved: eficonazole (Jublia) and tavaborole (Kerydin).
Ciclopirox, available as an 8% nail lacquer, is indicated for treatment of mild to moderate onychomycosis. It is available as an 8% topical solution formulated as a nail lacquer. Ciclopirox is applied daily and then removed with alcohol weekly. Nail trimming is advised along with its use.
Two clinical studies evaluated the efficacy and safety of ciclopirox in more than 450 patients with onychomycosis of the great toenails. After 48 weeks of application and monthly debridement of free nail, complete cure rates were 5.5% (vs 0.9% with vehicle) and 8.5% (vs 0% with vehicle) in the two studies, respectively. Mycological cure rates (i.e. negative fungal cultures) were 29% with ciclopirox vs 11% with vehicle and 36% with ciclopirox vs 9% with vehicle in the two studies, respectively. The most common adverse effects were application site reactions.
Efinaconazole, a triazole, was approved by the FDA in June 2014 for the treatment of onychomycosis of the toenails caused byT rubrum or T mentagrophytes. Efinaconazole is applied topically once daily for 48 weeks. Nail debridement is not required.
Clinical studies evaluated the efficacy of efinaconazole in more than 1600 patients with onychomycosis. Complete cure rates after 52 weeks 18.5% vs 4.7% with vehicle in data combined from two studies. Mycological cure rates at week 52 were 56.3% vs 16.6% with vehicle. Application site dermatitis and vesicles were the most commonly reported adverse events.
In July 2014 tavaborole, an oxaborole antifungal, was approved by the FDA for the treatment of onychomycosis of the toenails caused by T rubrum or T mentagrophytes. Tavaborole is applied once daily for 48 weeks. Debridement is not required.
The efficacy of tavaborole was evaluated in two clinical trials in almost 1200 patients. In the two studies, complete cure rates were 6.5% with tavaborole vs 0.5% with vehicle and 9.1% with tavaborole vs 1.5% vehicle, respectively. in the two studies, mycological cure rates were 31.1% with tavaborole vs 7.2% with vehicle and 35.9% with tavaborole vs 12.2% with vehicle, respectively.
Overall, the cure rates with these new vehicles is an advance over prior care. These topical treatments are an option for those unable to take oral antifungal medications, or may be useful adjuncts to oral or laser therapy.