Distal/lateral Subungual onychomycosis (DSO) caused by dermatophytes MedDRA version: 8.1 Level: LLT Classification code 10030338 Term: Onychomycosis
Conditions
Interventions
Product Name: TLT Antifungal Formulation - Terbinafine hydorchloride/Ethanol Solution
Pharmaceutical Form: Spot-on solution
INN or Proposed INN: terbinafine
CAS Number: 78628-80-5
Concentration unit:
Sponsors
TLT Medical Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male or female between 18 and 75 years of age of any race. 2) Subjects must present with distal/lateral subungual onychomycosis of at least one great toenail at Visit 1 with a degree of involvement of 15% to 75% at screening day. 3) A positive KOH examination and a positive dermatophyte culture using a validated test from nail specimens taken from the target nails within 20 to 35 days prior to the Day 1 visit. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Subjects with nail infections due to organisms other than dermatophytes (e.g. Candida or non-dermatophyte molds) as determined using a suitable culture and proper sampling method; i.e. no mixed infections. 2) Pregnant or lactating women. 3) Subjects with known hypersensitivity to terbinafine or ciclopirox or to any of the ingredients in the study drugs. 4) Subjects with structural deformities of the affected nails, toes or foot that would interfere with the digital photography needed for the planimetric analyses and/or appropriate immobilization of the target toe during the laser treatment. 5) Subjects that had used oral antifungals (e.g. Lamisil or Sporanox) to treat onychomycosis during the previous 6 months. 6) Subjects that had used topical antifungal formulation (e.g. Mycoster, Batrafen or Loceryl) to treat onychomycosis during the last 3 months. 7) Patients with a dermatophytoma.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective of this trial will be to demonstrate superior efficacy at Week 48 in terms of complete cure for the treatment of onychomycosis infected toe nails treated for 48 weeks with either a two-phase topical TLT formulation system consisting of a 10% terbinafine ethanolic solution and an 8% terbinafine lacquer in nails pre-treated with the laser with the TLT laser method which creates an array of partially perforated holes (Study arm 1) compared to 8% ciclopirox lacquer as comparator in intact toenails nails (i.e. nails not treated with the laser) (Study arm 2). Complete cure is defined as 100% clear nails, KOH negative and culture negative. ;Secondary Objective: 1. To asses time-to-complete-cure, effectively treated/almost clear and mycological cure for the treatment of onychomycoses infected toenails in nails treated with: - A two-phase topical TLT formulation system (Study arm 1) in nails pre-treated with the TLT laser method as compared with the efficacy of: - 8% ciclopirox lacquer as comparator (Study arm 2) in intact toenails nails (i.e. nails not treated with the laser). 2. To determine the efficacy after a 12 weeks follow-up period (i.e., without topical application) after the end of the treatment to determine relapse. Only those patients from both study arms who achieved complete cure (i.e., those meeting the stringent treatment cure criteria) will be eligible for the follow-up assessment. 3. To determine the safety and tolerance of the TLT laser pre-treatment at Day 1. ;Primary end point(s): Complete cure (defined as 100 % clear nails, mycological KOH assessment negative and mycological culture negative; determined by digital planimetry and mycological assessments) | — |
Countries
Iceland
Outcome results
None listed