[ORIgINAL
ReSeARCH]
Efinaconazole Topical Solution, 10%, for the Treatment of Mild and Moderate Toenail Onychomycosis DAVID A. RODRIGUEZ, MD Dermatology Associates/Research, Coral Gables, Florida
ABSTRACT Objective: To evaluate efficacy, safety, and tolerability of efinaconazole topical solution, 10%, in patients with mild (≤25% nail involvement) and moderate (>25% nail involvement) toenail onychomycosis. Methods: A subgroup analysis of patients, aged 18 to 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 endpoint was complete cure rate (0% clinical involvement of target toenail and both negative potassium hydroxide examination and fungal culture) at Week 52. Results: Mycologic cure rates were similar in mild and moderate onychomycosis patients treated with efinaconazole (58.2% and 55.5%, respectively), but markedly different with vehicle (25.0% and 14.1%, respectively). The primary endpoint, complete cure, was achieved in 25.8 percent of mild onychomycosis patients and 15.9 percent of moderate onychomycosis patients compared to 11.3 and 2.7 percent, respectively, with vehicle (both P25% nail involvement) onychomycosis.
METHODS 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 1,655 male and female patients aged 18 to 70 years with mild-to-moderate toenail onychomycosis.8 Patients who presented with 20 to 50 percent clinical involvement of the target toenail were randomized (3:1) to apply blinded study drug once daily to the toenails for 48 weeks. Representative examples of patients with 20 and 50 percent target toenail
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onychomycosis (≤25% nail involvement) and 1,237 patients with moderately severe onychomycosis MILD MODERATE (>25% nail involvement). Pooled ONYCHOMYCOSIS ONYCHOMYCOSIS results (Observed Case, OC) are ≤25% NAIL INVOLVEMENT >25% NAIL INVOLVEMENT provided below. Patients with mild onychoAge, y (SD) mycosis (≤25% target toenail involvement). At baseline, mean Mean 50.7 (11.9) 51.8 (11.2) patient age was 50.7 years. The Median 52.0 53.0 majority of patients (369, 89.1%) were aged 25% White 312 (75.4%) 939 (75.9%) target toenail involvement). At baseline, mean patient age was 51.8 Black/African American 34 (8.2%) 64 (5.2%) years. The majority of patients (1064, 86.0%) were aged
ReSeARCH]
Efinaconazole Topical Solution, 10%, for the Treatment of Mild and Moderate Toenail Onychomycosis DAVID A. RODRIGUEZ, MD Dermatology Associates/Research, Coral Gables, Florida
ABSTRACT Objective: To evaluate efficacy, safety, and tolerability of efinaconazole topical solution, 10%, in patients with mild (≤25% nail involvement) and moderate (>25% nail involvement) toenail onychomycosis. Methods: A subgroup analysis of patients, aged 18 to 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 endpoint was complete cure rate (0% clinical involvement of target toenail and both negative potassium hydroxide examination and fungal culture) at Week 52. Results: Mycologic cure rates were similar in mild and moderate onychomycosis patients treated with efinaconazole (58.2% and 55.5%, respectively), but markedly different with vehicle (25.0% and 14.1%, respectively). The primary endpoint, complete cure, was achieved in 25.8 percent of mild onychomycosis patients and 15.9 percent of moderate onychomycosis patients compared to 11.3 and 2.7 percent, respectively, with vehicle (both P25% nail involvement) onychomycosis.
METHODS 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 1,655 male and female patients aged 18 to 70 years with mild-to-moderate toenail onychomycosis.8 Patients who presented with 20 to 50 percent clinical involvement of the target toenail were randomized (3:1) to apply blinded study drug once daily to the toenails for 48 weeks. Representative examples of patients with 20 and 50 percent target toenail
[June 2015 • Volume 8 • Number 6]
25
onychomycosis (≤25% nail involvement) and 1,237 patients with moderately severe onychomycosis MILD MODERATE (>25% nail involvement). Pooled ONYCHOMYCOSIS ONYCHOMYCOSIS results (Observed Case, OC) are ≤25% NAIL INVOLVEMENT >25% NAIL INVOLVEMENT provided below. Patients with mild onychoAge, y (SD) mycosis (≤25% target toenail involvement). At baseline, mean Mean 50.7 (11.9) 51.8 (11.2) patient age was 50.7 years. The Median 52.0 53.0 majority of patients (369, 89.1%) were aged 25% White 312 (75.4%) 939 (75.9%) target toenail involvement). At baseline, mean patient age was 51.8 Black/African American 34 (8.2%) 64 (5.2%) years. The majority of patients (1064, 86.0%) were aged
