An Open Label Phase 2a Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Hallux Terbinafine Subungual Gel Administered to the Toenail Bed of Patients With Distal-Lateral Subungual Onychomycosis
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
- Hallux, Inc.
- Enrollment
- 35
- Locations
- 4
- Primary Endpoint
- Complete Cure at Week 52 in the Target Toe
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
HSG
Hallux terbinafine subungual gel
Intervention: Hallux Terbinafine Subungual Gel (Drug)
Outcomes
Primary Outcomes
Complete Cure at Week 52 in the Target Toe
Time Frame: 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 Outcomes
- Clinical Cure in the Target Toe(Week 52)
- Positive Response in the Target Toe(Week 52)
- Mycological Cure in the Target Toe(Week 52)