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

Hallux, Inc.

Status and phase

Active, not recruiting

Phase 2

Conditions

Onychomycosis of Toenail

Treatments

Drug: Hallux Terbinafine Subungual Gel

Study type

Interventional

Funder types

Industry

Identifiers

NCT05135910

HSG-201

Details and patient eligibility

About

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).

Full 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.

Enrollment

35 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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