Efinaconazole Topical Solution, 10%: The Benefits of Treating Onychomycosis Early
January 2015 | Volume 14 | Issue 1 | Original Article | 58 | Copyright © January 2015
Phoebe Rich MD
Oregon Dermatology and Research Center, Portland, OR
OBJECTIVE: To evaluate efficacy of efinaconazole topical solution, 10% in onychomycosis patients with early and long-standing disease.
METHODS: An analysis of 1655 patients, aged 18-70 years, randomized to receive efinaconazole topical solution, 10% or vehicle from
two identical multicenter, double-blind, vehicle-controlled 48-week studies evaluating safety and efficacy. The primary end point was
complete cure rate (0% clinical involvement of target toenail, and both negative potassium hydroxide examination and fungal culture)
at Week 52. Three groups were compared: those with early disease (<1year), patients with a baseline disease of 1-5 years, and those
with long-standing onychomycosis (>5years).
RESULTS: The majority of patients had long-standing disease; were older, male and white. While nail involvement of the target toenail
did not differ noticeably amongst the three groups, the number of nails involved did increase progressively with disease duration. Differences
were seen in terms of infecting pathogens in early disease that might have important treatment implications. Efinaconazole
was more effective in treating early disease, however more than 40% of patients with long-standing disease were considered treatment
LIMITATIONS: A period of 52 weeks may be too brief to evaluate a clinical cure in onychomycosis.
CONCLUSIONS: Treatment of onychomycosis early to avoid disease progression to other toenails is important. Once daily efinaconazole
topical solution, 10% is particularly effective in these patients. J Drugs Dermatol.
Onychomycosis is a progressive fungal infection of the
nail bed, matrix or plate; it leads to destruction and
deformity of the toenails and (less frequently) fingernails. 1,2 It represents up to 50% of all nail disorders, and is nearly
always associated with tinea pedis.1,3 Toenail onychomycosis
frequently involves several nails4 and can be more challenging
to treat because of the nail’s slow growth rate.5,6
Onychomycosis is caused by dermatophyte fungi (mainly Trichophyton rubrum) in up to 90% of cases, but can also be
due to other fungi such as yeasts (mainly Candida albicans) or
molds (mainly Scopulariopsis brevicaulis).2
Onychomycosis is not self-healing and may be a source of more
widespread fungal lesions, spreading to other digits, other sites
(groin, skin, scalp), and even to family members if not treated
and managed effectively.7
Many onychomycosis patients suffer from onychomycosis that
has been present for several years. Long-standing disease, the
number of toenails involved and co-existing fingernail disease
significantly influence its psychosocial effects.8,9 In a study of
patients who had onychomycosis of over 10 years duration,
41% reported pain or discomfort, reflecting the continuing impact
associated with this condition.10
Early treatment before the disease progresses to total dystrophic
onychomycosis can increase cure rate and may avoid the
need for systemic treatments.
Two identical 52-week prospective, multicenter, randomized,
double-blind studies in 1655 patients (18-70 years) assessed
the safety and efficacy of efinaconazole topical solution, 10%
in the treatment of onychomycosis. We provide an analysis of
efficacy based on the duration of disease at baseline to provide
important insights in the early treatment of the disease.
Two multicenter, randomized, double-blind, vehicle-controlled
studies designed to evaluate the efficacy, safety, and tolerability
of efinaconazole topical solution, 10% relative to its vehicle
in 1655 male and female patients aged 18 to 70 years with mild
to moderate toenail onychomycosis.
Patients who presented with 20%-50% clinical involvement of
the target toenail were randomized (3:1) to apply blinded study