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

Hallux, Inc.35 enrolled

Overview

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).

Primary Efficacy: To identify patients achieving Complete Cure in the target toenail at Week 52. Secondary Efficacy: To identify patients that have achieved 1) Clinical Cure, 2) Mycological Cure, and/or 3) Positive Response in the target toenail at Week 52. Plasma Pharmacokinetics: To characterize concentrations of terbinafine and major metabolite in a subpopulation of patients over the study period. Nail Pharmacokinetics: To characterize concentrations of terbinafine and major metabolite in distal nail clippings in patients over the study period. HSG Safety and Tolerability Profile: To establish from plasma pharmacokinetics, related adverse events, treatment site reactions, pain, clinically significant changes in medical condition and/or medications, and clinically significant changes in liver function, serum chemistry, urinalysis, and complete blood count over the study period. Subungual Topical Procedure: To establish the ease and durability of once monthly and once bi-monthly HSG subungual topical treatments, the Investigator will record at selected time points 1) nail measurements indicating progressive clearing, 2) the ease and depth of each topical administration, 3) the investigational drug volume administered each treatment, and 4) patient tolerability.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Onychomycosis of Toenail

Interventions

Hallux Terbinafine Subungual GelDRUG

Hallux Terbinafine Subungual Gel (HSG) administered every 1 to 2 months over 44 weeks.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Locations (4)

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

Outcomes

Primary Outcomes

Complete Cure at Week 52 in the Target Toe

Complete Cure is defined as 1) 100% healthy, clear nail, and 2) negative mycology. Healthy, clear nail is absent any disease involvement attributable to DLSO and is determined by Investigator Global Assessment (IGA). Negative mycology is defined as zero visualization of septate hyphae by KOH microscopy (negative KOH) combined with a fungal culture negative for causal dermatophytes (negative fungal culture).

Time frame: Week 52

Secondary Outcomes

Clinical Cure in the Target Toe

100% healthy, clear nail

Time frame: Week 52

Mycological Cure in the Target Toe

Negative KOH, negative fungal culture

Time frame: Week 52

Positive Response in the Target Toe

≥ 80% decrease in disease involvement

Time frame: Week 52

Data from ClinicalTrials.gov

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