To Evaluate Hallux Terbinafine Subungual Gel (HSG) in the Treatment of Onychomycosis

Status unconfirmed · Phase 2

Conditions studied: Onychomycosis of Toenail

In brief

The key objective is to establish the efficacy, safety, tolerability, and pharmacokinetics of investigational drug Hallux Terbinafine Subungual Gel (HSG) administered over 44 weeks to patients with distal-lateral subungual onychomycosis (DLSO).

Key facts

Study ID

NCT05135910

Run by

Hallux, Inc.

People needed

35

Starts

2022-01-13

Expected to finish

2024-09-30

Last updated by the study team

2023-08-07

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and females 18 - 75 years of age inclusive
• Patients with DLSO of at least one great toe
• Patients with DLSO in the target toe confirmed by positive KOH and positive fungal culture for dermatophytes
• Willingness to abstain from pedicures, nail clipping, or application of nail polish or nail cosmetics to their toenails over the study period

You may not qualify if…

• History of any significant chronic fungal disease other than onychomycosis or an immunocompromised condition
• Any previous surgery to or abnormalities of the target toe that in the investigator's opinion could prevent the toenail surface area from clearing even if eradication of the DLSO infection is achieved
• Participation in another clinical study of an investigational drug or device within 3 months of screening
• No administration of oral terbinafine or another oral antifungal within 6 months of screening
• No topical antifungal used for onychomycosis or a dermatophyte infection (i.e. tinea pedis) within 3 months of screening
• No uncontrolled diabetes mellitus
• No severe psoriasis or severe atopic dermatitis
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• OrthoArizona - East Valley Foot & Ankle Specialists — Mesa, Arizona, United States
• Front Range Foot and Ankle Clinic — Parker, Colorado, United States
• Oregon Dermatology & Research Center — Portland, Oregon, United States
• J&S Studies — College Station, Texas, United States

Full record on ClinicalTrials.gov

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