A randomized, open-label, active-controlled, multicenter, parallel group study to assess the efficacy, safety and tolerability of topical 10% terbinafine hydrogen chloride (HCl) formulation versus 5% amorolfine nail lacquer for 48 weeks of treatment in patients with mild to moderate toenail onychomycosis

INTERVENTION: Product Name: 10% Terbinafine HCl NSO Product Code: SFO327N Pharmaceutical Form: Cutaneous solution INN or Proposed INN: Terbinafine Hydrochloride CAS Number: 91161‐71‐6 Current Sponsor code: SFO327 Concentration unit: % percent Concentration type: equal Concentration number: 10‐ Trade Name: Loceryl Pharmaceutical Form: Cutaneous solution INN or Proposed INN: Amorolfine CAS Number: 78613‐35‐1 Concentration unit: % percent Concentration type: equal Concentration number: 5‐ CONDITION: mild to moderate toenail onychomycosis ; MedDRA version: 8.1 Level: LLT Classification code 10030338 Term: Onychomycosis PRIMARY OUTCOME: Main Objective: To demonstrate the superiority of topical 10% terbinafine HCl NSO versus 5% amorolfine nail lacquer in terms of complete cure rate at the end of study (week 52), after treating patients with mild to moderate toenail onychomycosis for 48 weeks, where the complete cure is defined as having negative mycology culture, negative KOH microscopy and 0% residual involvement of onychomycosis of the target toenail. Primary end point(s): Demonstrate superiority of terbinafine vs amorolfine for complete cure rate at week 52 Secondary Objective: • To demonstrate the superiority of 10% terbinafine HCl NSO over 5% amorolfine nail lacquer in mycological cure (negative culture for dermatophytes and negative KOH microscopy) and in clinical effectiveness (= 10% residual involvement of the target toenail and culture negative for dermatophytes and negative KOH microscopy) after treating patients with mild to moderate toenail onychomycosis for 48 weeks.; ; • To assess the safety of and tolerability of 10% terbinafine HCl NSO versus 5% amorolfine nail lacquer in terms of reported adverse events and laboratory values.; ; ; Exploratory objective(s); ; • To explore the efficacy in terms of complete cure rate, mycological cure rate, and clinical effectiveness at week 24 and week 36.; ; • To explore the efficacy in terms of clinical cure (defined as 0% residual involvement of onychomycosis of the target toenail) at week 52.; ; • To explore patient’s satisfaction with medication for the treatment of onychomycosis.; ; ; 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 (18‐6