Topical Efinaconazole 10% for Onychomycosis: Pooled Phase 3 Analysis in White, Black, and Asian Participants

Document Type

Article

Publication Date

1-1-2026

Publication Title

Journal of drugs in dermatology : JDD

Keywords

Adolescent, Adult, Aged, Female, Humans, Male, Middle Aged, Young Adult, Administration, Cutaneous, Administration, Topical, Antifungal Agents, Double-Blind Method, Foot Dermatoses, Onychomycosis, Treatment Outcome, Triazoles, Asian, Black or African American, White

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.  .

Medical Subject Headings

Adolescent; Adult; Aged; Female; Humans; Male; Middle Aged; Young Adult; Administration, Cutaneous; Administration, Topical; Antifungal Agents; Double-Blind Method; Foot Dermatoses; Onychomycosis; Treatment Outcome; Triazoles; Asian; Black or African American; White

PubMed ID

41493257

Volume

25

Issue

1

First Page

67

Last Page

74

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