A Phase 2 interventional study of Hallux Terbinafine Subungual Gel in Onychomycosis of Toenail, sponsored by Hallux, Inc.. Active, not recruiting at 4 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-08-07.
Sponsored by Hallux, Inc. · Phase 2, Interventional, and Treatment
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.
147 studies on the registry are indexed under Onychomycosis; 13 are open to participants now.
This study's planned enrollment of 35 is below the median of 56 across 134 interventional studies indexed under Onychomycosis.
Browse Onychomycosis studies →Hallux, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Hallux terbinafine subungual gel
Drug: Hallux Terbinafine Subungual Gel
Hallux Terbinafine Subungual Gel (HSG) administered every 1 to 2 months over 44 weeks.
Also known as: HSG
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
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
Plasma Pharmacokinetics
To characterize plasma concentrations of terbinafine and metabolite from a subset of patients over the study period
Time frame: Week 52
Nail Pharmacokinetics
To characterize nail concentrations of terbinafine and metabolite from patients over the study period
Time frame: Week 52
Subungual Topical Procedure
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.
Time frame: Week 44
Patient Global Assessment
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)
Time frame: Week 52
Safety and Tolerability: Established from patient incidence of Treatment-Emergent Adverse Events
Indicated by the number of patients with treatment-related adverse events assessed by Common Terminology Criteria for Adverse Events (CTCAE)
Time frame: Monitored from screening visit to end of study visit (Week 52)
Safety and Tolerability: Established from clinical laboratory results
Indicated by clinically significant changes in patient liver function, serum chemistry, urinalysis, and complete blood count over the study period
Time frame: Monitored at selected time points from screening visit to end of study visit (Week 52)
Safety and Tolerability: Established from patient reported medical condition and use of medications
Monitored by assessing clinically significant changes in patient medical condition and/or use of medications over the study period
Time frame: Monitored from screening visit to end of study visit (Week 52)
Plan to share: No — This is a phase II study. Individual participant data (IPD) of this study will not be shared.
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This study is active, not recruiting, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Hallux, Inc.