NCT07382427

A Phase 2 Study to Assess the Effectiveness of Topical Terbinafine in Participants With Mild to Moderate Onychomycosis of the Toenails

A Phase 2, Randomized, Single-blind, Active- and Vehicle-controlled Study to Assess the Safety, Tolerability, and Efficacy of 2.4% Terbinafine Hydrochloride Topical Solution (AP4500) in Participants With Mild to Moderate Onychomycosis of the Toenails

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Onyx Axiom · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Onychomycosis is a fungal infection of the toenail caused by a range of organisms, including dermophytes, non-dermophyte molds, and yeasts. Topical antifungals are often used for mild to moderate onychomycosis, especially when oral therapy is contraindicated. Generally, topical antifungal agents are well-tolerated with minimal side effects, but they are less effective than oral antifungal therapies due to poor nail penetration. Consequently, the current treatment period for topical onychomycosis products is \~12 months. Terbinafine is an antifungal drug approved by the FDA for the treatment of topical skin infections. A new formulation (AP4500) has been developed to increase terbinafine absorption through the nail in order to directly kill fungi at the site of onychomycosis infection. The goal of this clinical trial is to learn if AP4500 works to treat mild to moderate toenail fungus in adults. The main questions the study aims to answer are: Does AP4500 work to treat onychomycosis? Does AP4500 work best when applied once or twice per day? Does AP4500 treat onychomycosis faster than current treatments? Is AP4500 more effective than current treatments? Researchers will compare AP4500 to a vehicle control (a look-alike substance that contains no drug) and a commercial comparator product (Jublia) that has already been commercialized for the treatment of toenail fungus. Participants will: Apply topical formulations once or twice a day to an infected toenail for a period of 48 weeks Visit the clinic 4 times over this period for checkups and tests, with a subsequent follow up visit 4 weeks after treatment is completed

Conditions

• Onychomycosis of Toenail

Interventions

Type	Name	Description
DRUG	2.4% Topical Terbinafine	Novel topical terbinafine product designed to increase terbinafine absorption through the nail to the site of infection
DRUG	10% Topical Efinaconazole	Commercial topical efinaconazole formulation approved for the treatment of onychomycosis
OTHER	Vehicle Control	Vehicle control formulation to act as a control for the experimental product

Timeline

• Start date: 2026-03-01
• Primary completion: 2028-01-01
• Completion: 2028-02-01
• First posted: 2026-02-02
• Last updated: 2026-02-04