Topical Efinaconazole 10% for Onychomycosis: Pooled Phase 3 Analysis in White, Black, and Asian Participants
January 2026 | Volume 25 | Issue 1 | 67 | Copyright © January 2026
Published online December 31, 2025
Shari R. Lipner MD PhDa, Aditya K. Gupta MD PhDb,c, Tracey C. Vlahovic DPM FFPM RCPSd, Ted Rosen MD FAADe, Boni Elewski MDf, Su Yong Choi PharmDg, Eric Guenin PharmD PhD MPHg, Linda Stein Gold MDh
aWeill Cornell Medicine, Department of Dermatology, New York, NY
bMediprobe Research Inc., London, ON, Canada
cTemerty Faculty of Medicine, Division of Dermatology, Department of Medicine, University of Toronto, ON, Canada
dSamuel Merritt University College of Podiatric Medicine, Oakland, CA
eBaylor College of Medicine, Houston, TX
fUniversity of Alabama at Birmingham School of Medicine, Birmingham, AL
gOrtho Dermatologics,* Bridgewater, NJ
hHenry Ford Hospital, Department of Dermatology, Detroit, MI
Abstract
Background: Topical efinaconazole 10% solution has demonstrated efficacy and safety in two phase 3 trials of onychomycosis. As clinical data for onychomycosis treatments are limited in patients with skin of color, this post hoc analysis evaluated efinaconazole in participants categorized by race.
Methods: Data were pooled from 2 multicenter, double-blind, phase 3 trials (NCT01007708, NCT01008033). Participants aged 18 to 70 years with mild-to-moderate distal lateral subungual onychomycosis in ≥1 great toenail were randomized (3:1) to once-daily efinaconazole or vehicle for 48 weeks. Efficacy endpoints at week 52 included rates of mycologic cure (MC; negative potassium hydroxide examination + negative fungal culture), complete cure (0% clinical involvement + MC), complete/almost complete cure (≤5% clinical involvement + MC), and clinical efficacy (<10% clinical involvement). Adverse events (AEs) were assessed.
Results: Participants (n=1655) were categorized by self-reported race: White (n=1251), Asian (n=269), or Black (n=98). At week 52, more efinaconazole- vs vehicle-treated participants achieved complete cure (White, 14.7% vs 2.0%; Asian, 27.5% vs 13.0%; Black, 12.9% vs 7.1%), complete/almost complete cure (22.8% vs 4.6%; 35.5% vs 18.8%; 25.7% vs 7.1%), and clinical efficacy (31.2% vs 8.6%; 46.0% vs 23.2%; 31.4% vs 21.4%). Mycologic cure rates were also higher with efinaconazole (range: 53.4%–61.4%) vs vehicle (10.7%–30.4%). Most treatment-emergent AEs with efinaconazole were mild/moderate, with low discontinuation rates (<6%).
Conclusions: Topical efinaconazole 10% showed favorable efficacy/safety in White, Asian, and Black participants with mild-to-moderate onychomycosis. Results were generally consistent with the overall phase 3 populations and position efinaconazole as an efficacious treatment for patients, regardless of race.
INTRODUCTION
Onychomycosis, a chronic fungal infection of the nail plate or bed, affects up to 14% of individuals in North America and is the most commonly diagnosed nail disorder in the United States.1,2 Onychomycosis can cause toenail deformity, discomfort, and pain; interfere with daily living activities; act as a risk factor for other infections, including lower-extremity cellulitis; exacerbate foot problems from other illnesses, such as diabetes; and negatively affect quality of life and well-being.2-5
Although it is a common infection, prevalence data regarding onychomycosis in patients with skin of color (SoC) are lacking.6 The US National Ambulatory Medical Care Survey showed that patients with healthcare visits and a diagnosis of onychomycosis in the years 1993-2010 were 84.6% White, 7.6% Black, and 1.9% Asian.6 Another retrospective study found that while Black and Hispanic patients in the US comprised a smaller proportion of the patient population with onychomycosis (19.6% and 16.0%, respectively, vs 44.9% White), their risk of onychomycosis was greater than White patients (Black and Hispanic odds ratios
