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

Phase 2

Active, not recruiting

• Conditions: Onychomycosis of Toenail
• Interventions: Drug: Hallux Terbinafine Subungual Gel

• Registration Number: NCT05135910
• Lead Sponsor: Hallux, Inc.

Brief Summary

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).

Detailed Description

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 Timeline

• Study First Submitted: 2021-10-28
• Study First Submitted QC: 2021-11-16
• Study First Posted: 2021-11-26
• Study Start: 2022-01-13
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-03
• Last Update Posted: 2023-08-07
• Primary Completion: 2024-09-30
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HSG	Hallux Terbinafine Subungual Gel	Hallux terbinafine subungual gel

Primary Outcome Measures

Name	Time	Method
Complete Cure at Week 52 in the Target Toe	Week 52	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).

Secondary Outcome Measures

Name	Time	Method
Clinical Cure in the Target Toe	Week 52	100% healthy, clear nail
Positive Response in the Target Toe	Week 52	≥ 80% decrease in disease involvement
Mycological Cure in the Target Toe	Week 52	Negative KOH, negative fungal culture

Trial Locations

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