Onychomycosis (mild to moderate) MedDRA version: 8.1 Level: LLT Classification code 10030338 Term: Onychomycosis
Conditions
Interventions
Product Name: Lamisil Nail Solution
Product Code: SFO327N
Pharmaceutical Form: Cutaneous solution
INN or Proposed INN: Terbinafine Hydrochloride
Current Sponsor code: SFO327
Concentration unit: % perc
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Outpatients of either sex and 12 – 75 years of age. 2. Clinically suspected dermatophyte infection confirmed by a positive KOH microscopy and culture performed by the central mycology laboratory. 3. The target toenail area must have at least 25% to no more than 75% disease involvement without spikes. 4. At least 1 large (great) toenail meeting the infection criteria. (If more than 1 large toenail is infected and meets inclusion/exclusion criteria, both toenails should be sampled for culture. The toenail with greater involvement will be selected as the target nail. If both large toenails have the same degree of involvement, the right toenail will be selected as the “target” toenail. 5. The target large toenail must be confirmed as having at least a minimum of 1 mm growth, measured by the site, within the 4-6 week screening period. Are the trial subjects under 18? yes 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. Patients who have had systemic antifungal therapy within 6 months prior to screening for the study. 2. Patients who have used prescription topical antifungal therapy indicated for onychomycosis within 3 months prior to screening, or commercially available topical antifungal therapy for onychomycosis or any other commercially available topical antifungal therapy applied directly to the toenails within 1 month prior to screening. 3. Patients who have used other investigational drugs at the time of enrollment or within 30 days. 4. Nail infection due to an organism other than a dermatophyte (mixed infections [dermatophyte and non-dermatophyte] are not allowed). 5. The target foot has severe plantar (moccasin) tinea pedis infection that would require systemic therapy (as determined by the investigator). Mild to moderate tinea pedis infection should be treated with Lamisil DermGel, or with Lamisil Cream if Lamisil DermGel is unavailable, to eliminate fungal reservoir as needed prior to baseline or at any time during the trial. Other topical treatments indicated for tinea pedis may be recommended at the discretion of the investigator. 6. Patients with the target toenail involving the matrix (lunula) or having less than 2mm clear (unaffected) nail plate length beyond the proximal fold. 7. Presence of dermatophytoma (defined as thick masses of fungal hyphae and necrotic keratin between the nail plate and nail bed) on the target nail. 8. Patients with abnormalities of the target nail that could prevent obtaining a normal appearing nail if clearing of the infection is achieved (i.e. tumors, chemical damage, genetic disorders, pigmentary disorders, psoriasis, collagen vascular disease, lichen planus, peripheral vascular disease, traumatic onychodystrophy due to chronic stimuli, structural deformity, severe diabetic foot neuropathy). 9. Patients with abnormal findings (laboratory or physical) or conditions which are considered to be clinically important by the investigator and indicative of conditions that could jeopardize patient safety or interfere with the interpretation of the results of the study. Please note: diabetic patients may be enrolled in the study if their diabetes is well-controlled. 10. Patients with a history of malignancy of any organ system within the past year, whether or not there is recurrence or metastases, with the exception of localized basal cell or squamous cell carcinoma of the skin for which medical intervention should be planned. 11. Known pregnant or lactating women at the time of enrollment or patients who plan to become pregnant during the study period. 12. Patients with sensitivity to terbinafine or excipients of the formulation. 13. Patients not likely or unable to cooperate with study requirements including those with a recent history of alcohol or drug abuse, or are currently known to abuse alcohol or drugs. 14. Patients not willing to stop professional pedicures, or not willing to remove or discontinue the use of any nail polish product or other nail cosmetic product on their toenails at the screening visit and throughout the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the superiority of topical terbinafine HCl formulation vs. vehicle in terms of complete cure rate (refer to section 7.4) in patients with mild to moderate toenail onychomycosis at the end of study (i.e., 52 weeks after the initial application) after treating for 24 or 48 weeks.;Secondary Objective: To demonstrate the efficacy of topical terbinafine HCl formulation vs. vehicle in terms of mycological cure and clinical effectiveness at the end of study (refer to section 7.4) after treating patients for 24 or 48 weeks by testing the hypothesis that topical terbinafine hydrogen chloride (HCl) is superior to vehicle. To assess the safety of terbinafine hydrogen chloride (HCl) vs. vehicle in terms of reported adverse events. Exploratory objective : To evaluate clinical cure after treating patients for 24 or 48 weeks. ;Primary end point(s): To demonstrate the superiority of topical terbinafine HCl formulation vs. vehicle in terms of complete cure rate (refer to section 7.4) in patients with mild to moderate toenail onychomycosis at the end of study (i.e., 52 weeks after the initial application) after treating for 24 or 48 weeks. The primary efficacy variable is complete cure rate achieved at the end of study (week 52 after the initiation of study drug). The complete cure is a composite binary variable defined as ‘Yes’ if - mycological cure (negative KOH and negative culture for dermatophytes) and - No residual involvement of the target toenail | — |
Countries
Iceland
Outcome results
None listed