From the Guidelines
Onychomycosis of the toe should be treated with oral terbinafine 250mg daily for 12-16 weeks as the first-line treatment, due to its higher efficacy and tolerability compared to other options. This recommendation is based on the British Association of Dermatologists' guidelines for the management of onychomycosis 2014 1. The guidelines suggest that terbinafine has a higher cure rate compared to itraconazole, with a complete cure rate of 55% compared to 26% for pulsed itraconazole at 72 weeks follow-up.
Some key points to consider when treating onychomycosis of the toe include:
- Confirmation of the diagnosis with a nail clipping for fungal culture or KOH preparation is recommended before starting treatment 1
- Treatment takes time because toenails grow slowly, and complete resolution may require 9-12 months as the infected nail grows out
- Recurrence is common (10-50%), so preventive measures are important, including keeping feet dry, wearing breathable footwear, using antifungal powders, and avoiding walking barefoot in public areas
- Patients with diabetes or immunocompromised conditions should be particularly vigilant about treating onychomycosis to prevent complications
Alternative options for treatment include:
- Itraconazole 200mg twice daily for 1 week per month, repeated for 3-4 months 1
- Fluconazole 150-300mg once weekly for 6-12 months 1
- Topical treatments like ciclopirox 8% nail lacquer or amorolfine 5% nail lacquer, which are less effective but may be used for mild cases or when oral medications are contraindicated 1
It's worth noting that the British Association of Dermatologists' guidelines recommend terbinafine as the first-line treatment for dermatophyte onychomycosis, due to its higher efficacy and tolerability compared to other options 1.
From the FDA Drug Label
Terbinafine tablets, USP are indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium). Ciclopirox Topical Solution, 8%, (Nail Lacquer), as a component of a comprehensive management program, is indicated as topical treatment in immunocompetent patients with mild to moderate onychomycosis of fingernails and toenails without lunula involvement, due to Trichophyton rubrum
Treatment Options for Onychomycosis of the Toe:
- Terbinafine (PO): indicated for the treatment of onychomycosis of the toenail due to dermatophytes 2
- Ciclopirox (TOP): indicated as topical treatment for mild to moderate onychomycosis of toenails without lunula involvement, due to Trichophyton rubrum 3
From the Research
Onychomycosis of the Toe: Treatment Options
- Onychomycosis of the toe is a fungal infection that can be difficult to treat, with high relapse rates 4, 5.
- Terbinafine is an orally active antimycotic agent that has demonstrated excellent fungicidal activity against dermatophytes and variable activity against yeasts and non-dermatophyte molds in vitro 4.
- Studies have shown that terbinafine is more efficacious than itraconazole, fluconazole, and griseofulvin in treating dermatophyte onychomycosis of the toenails 4, 6.
Treatment Regimens
- A 12-week treatment regimen of terbinafine 250 mg/day has been shown to be effective in treating dermatophyte toe onychomycosis, with a mycologic cure rate of 73% at week 48 6.
- Combining oral terbinafine with topical antifungal agents such as amorolfine or ciclopirox may enhance treatment success rates due to additive or synergistic modes of action 7.
- Topical therapy with amorolfine, ciclopirox, tavaborole, or efinaconazole may be appropriate for cases of mild to moderate toenail onychomycosis due to dermatophyte or mixed dermatophyte/Candida infection 8.
Efficacy and Safety
- Terbinafine has been shown to have a better tolerability profile than griseofulvin and a comparable profile to that of itraconazole or fluconazole 4.
- The most common adverse events associated with terbinafine are gastrointestinal complaints, which were experienced by 10.5% of recipients 4.
- Post-marketing surveillance has confirmed terbinafine's good tolerability profile, with a low potential for drug-drug interactions 4.