Onychomycosis of Toenail
Conditions
Keywords
Onychomycosis
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.
Interventions
DRUGHallux Terbinafine Subungual Gel
Hallux Terbinafine Subungual Gel (HSG) administered every 1 to 2 months over 44 weeks.
Sponsors
Hallux, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Clinical Cure in the Target Toe | Week 52 | 100% healthy, clear nail |
| Mycological Cure in the Target Toe | Week 52 | Negative KOH, negative fungal culture |
| Positive Response in the Target Toe | Week 52 | ≥ 80% decrease in disease involvement |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability: Established from patient incidence of Treatment-Emergent Adverse Events | Monitored from screening visit to end of study visit (Week 52) | Indicated by the number of patients with treatment-related adverse events assessed by Common Terminology Criteria for Adverse Events (CTCAE) |
| Plasma Pharmacokinetics | Week 52 | To characterize plasma concentrations of terbinafine and metabolite from a subset of patients over the study period |
| Safety and Tolerability: Established from patient reported medical condition and use of medications | Monitored from screening visit to end of study visit (Week 52) | Monitored by assessing clinically significant changes in patient medical condition and/or use of medications over the study period |
| Safety and Tolerability: Established from clinical laboratory results | Monitored at selected time points from screening visit to end of study visit (Week 52) | Indicated by clinically significant changes in patient liver function, serum chemistry, urinalysis, and complete blood count over the study period |
| Nail Pharmacokinetics | Week 52 | To characterize nail concentrations of terbinafine and metabolite from patients over the study period |
| Subungual Topical Procedure | Week 44 | To evaluate the ease and durability of once monthly and once bi-monthly HSG subungual topical treatments to the target toe over 44 weeks. Nail measurements indicating progressive clearing are recorded from an Investigator Global Assessment scale referencing % disease involvement corroborated by nail image analysis. The ease and durability of subungual topical treatment is established using a 5-point Likert Scale. Patient local tolerability is established using a Treatment Site Assessment Scale and Pain Intensity Scale. |
| Patient Global Assessment | Week 52 | To establish each patient's impression of DLSO improvement in their target toe over the study period, patients will reference the following scale (0 = clear of DLSO, 1 = marked improvement of DLSO, 2 = moderately improved DLSO, 3 = slightly improved DLSO, 4 = unchanged, 5 = worse) |
Countries
United States
Outcome results
None listed