A Randomized, Single-Blinded, Comparative Study of Mycosinate and Curanail in the Treatment of Fungal Nail Infection

INTERVENTION: Product Name: Mycosinate Product Code: A3IS Pharmaceutical Form: Gel INN or Proposed INN: Glucose CAS Number: 77938‐63‐7 Current Sponsor code: CTP001B Other descriptive name: GLUCOSE Concentration unit: % (W/W) percent weight/weight Concentration type: equal Concentration number: 35‐ INN or Proposed INN: Glucose Oxidase CAS Number: 9001‐37‐0 Current Sponsor code: CTP001B Other descriptive name: GLUCOSE OXIDASE Concentration unit: % (W/W) percent weight/weight Concentration type: equal Concentration number: 0.50‐ Trade Name: Curanail Product Name: Curanail Pharmaceutical Form: Cream INN or Proposed INN: AMOROLFINE HYDROCHLORIDE CAS Number: 78613‐35‐1 Current Sponsor code: CTP001B Other descriptive name: AMOROLFINE Concentration unit: % (W/V) percent weight/volume Concentration type: equal Concentration number: 5‐ CONDITION: Onychomycosis Therapeutic area: Diseases [C] ‐ Skin and Connective Tissue Diseases [C17] PRIMARY OUTCOME: ; Main Objective: 1. % Reduction in the Size of Infection; Photos taken during the trial will be analyzed by the statistician who will measure both the entire size of the nail and the size of the infected portion of the nail. Using this data, the statistician will be able to calculate the % reduction in the size of the infection as the trial progresses.; ; 2. Viability of the Infection at Time ‘T’ (Mycological Cure Rate); Confirmation testing will be carried out in a 3rd party contract laboratory and will be cultured to determine the viability of the infection at the various time points in the study.; ; Primary end point(s): 1) Viability of the infection; 2) % Reduction in the Size of Infection (Visual improvement); ; ; Secondary Objective: 1. Relapse Rates; The viability testing carried out from the month 6 follow up visit will form the relapse rate results. If the infection is viable at 9 month and was not viable at month 6 then the patient has relapsed.; ; 2. Adverse Reactions; Any adverse reactions will be recorded and serious adverse reactions will be reported directly to the HPRA via the sponsor’s pharmacovigilance provider, Diamond Pharma Services.; ; Timepoint(s) of evaluation of this end point: Both primary endpoints assessed at T=0 weeks, 3 weeks, 6 weeks, 12 weeks, 6 months and 9 months; SECONDARY OUTCOME: ; Secondary end point(s): 1) Relapse rates; 2) Adverse events; ; Timepoint(s) of evaluation of this end point: 1) Relapse rates ‐ measured at 6 month and 9 month visits; 2) Adverse events ‐ recorded throughout duration of study; INCLUSION CRITERIA: • Confirmed presence of hyphae through microscopy of nail sample taken from patient. (Further details of nail sampling given in section 2.7.5) • In good overall health (Subject to Health Assessment conducted by the responsible Physician). • Male and Female aged between 18‐65 inclusive. • Fungal Infection on maximum of 2 nails per foot. • The fungal infection is seen across 20‐75% of the nail with no involvement of the lunula. (Details of nail sizing protocol given in section 2.8.1) • Subject is willing and available to return for study follow ups. • Subject is willing to discontinue use of cosmetic nail products for the duration of the study. • Subjects must agree to refrain from using other nail fungus treatments for the duration of the study • Physical examination without signi