Onychomycosis of Toenail Clinical Trial
Official title:
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
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03110029 -
Evaluating the Efficacy and Compatibility of Efinaconazole 10% Solution (Jublia) for the Treatment of Toenail Onychomycosis in Patients Wearing Toenail Polish Compared to Those Without Polish
|
Phase 4 | |
| Active, not recruiting |
NCT05110638 -
Safety and Tolerability Study of SKX-16 in Subjects With Moderate to Severe Distal Subungual Onychomycosis
|
Phase 1 | |
| Completed |
NCT05260450 -
Laser Treatment of Toenail Onychomycosis With a 1064 nm Nd:YAG-laser
|
N/A | |
| Completed |
NCT03382717 -
Efficacy and Safety of a Medical Device for the Treatment of Toenail Onychomycosis
|
N/A | |
| Withdrawn |
NCT03094468 -
Study to Evaluate the Efficacy and Safety of P-3058 Nail Solution in the Treatment of Onychomycosis
|
Phase 3 | |
| Recruiting |
NCT05674747 -
Pilot Study of Swift Microwave Device for Onychomycosis
|
Phase 1/Phase 2 | |
| Recruiting |
NCT06006455 -
Effect of the Erchonia® LunulaLaser™ for the Treatment of Toenail Onychomycosis
|
N/A | |
| Not yet recruiting |
NCT03098342 -
Comparison of Efficacy and Safety Between Methylene Blue-mediated Photodynamic Therapy and 5% Amorolfine Nail Lacquer for Toenail Onychomycosis Treatment
|
N/A | |
| Completed |
NCT03216200 -
Early Feasibility Study to Evaluate the Efficacy of the RenewalNail™ Plasma Treatment System in Patients With Onychomycosis (Fungal Nail)
|
N/A | |
| Recruiting |
NCT04042857 -
Safety and Efficacy of Next Science Gel on Toenail Fungus
|
N/A | |
| Active, not recruiting |
NCT05139888 -
Light Therapy for Onychomycosis Study
|
N/A | |
| Completed |
NCT04961684 -
Clinical Evaluation of Efficacy and Safety of a Medical Device for the Treatment of Toenail Onychomycosis
|
N/A | |
| Completed |
NCT03141840 -
Clinical Trial of Topical ABL01 Treatment of Onychomycosis
|
N/A | |
| Recruiting |
NCT04084782 -
An Internet Mediated Research Study to Assess the Quality of Life of Consumers With Self-reported Fungal Nail Infection (Onychomycosis) During Treatment With Scholl Fungal Nail.
|
||
| Withdrawn |
NCT03066336 -
A Study to See if Low Level Laser Light Can Help to Treat Toenail Fungus
|
N/A |