A CLINICAL TRIAL TO ASSESS THE EFFECT OF FOSRAVUCONAZOLE L-LYSINE ETHANOLATE CAPSULES IN PATIENTS WITH ONYCHOMYCOSIS

INTERVENTION: Intervention1: Fosravuconazole L‐Lysine ethanolate Capsules: Test Arm: Patient in test arm will receive Fosravuconazole L‐Lysine ethanolate Capsules 169.1mg; and 2 capsules of matching placebo of Itraconazole Once daily for 12 weeks Control Intervention1: Itraconazole 200 mg: Comparator arm: Patient in comparator arm will receive Itraconazole 200 mg (2 capsules of 100 mg); and matching placebo of Fosravuconazole L‐Lysine ethanolate Capsule once daily for 12 weeks CONDITION: Health Condition 1: L088‐ Other specified local infections of the skin and subcutaneous tissue PRIMARY OUTCOME: Percentage of patients with complete cure (mycological cure + clinical cure) at week 48.Timepoint: At week 48 SECONDARY OUTCOME: To evaluate the safety and tolerability of Fosravuconazole L‐Lysine ethanolate Capsules 169.1mg in comparison with Itraconazole 200 mg for in patients with Onychomycosis.Timepoint: Percentage of patients with mycological /Complete/Clinical cure at week 12, 24, 36 and 48. ; Percentage of patients with clinical cure (defined as investigatorâ??s global assessment response of â??clearedâ?? or â??excellentâ??) at week 12, 24, 36 and 48. ; Relapse in terms of clinical (Clinical signs of infection determined at any time point subsequent to a clinical cure) or mycological relapse (Positive mycology determined at any time point subsequent to a mycological cure) by week 48 INCLUSION CRITERIA: 1. Male and female subjects between 18 to 65 years of age. 2. Clinical diagnosis of Onychomycosis in atleast one great toenail confirmed by positive mycological culture and microscopic (KOH examination) findings for a dermatophyte. (If both great toenails meet inclusion criteria, the toenail with the greater involvement will be designated the target toenail). 3. Clinical involvement affecting 25% or more of the toenail 4. Willing to comply with protocol requirements and sign a statement of informed consent 5. Willing to refrain from using on the toenails topical products on the affected toenail and to which the subject has a high risk of developing an allergic reaction and/or dermatitis 6. Female subjects of child‐bearing potential should have negative serum pregnancy test at screening and agree to use adequate birth control during the entire study period. OR Is surgically sterile (bilateral tubal