Phase III study to evaluate the anti-mycotic efficacy of a topical Abafungin formulation in patients with tinea pedis

INTERVENTION: Product Name: Abasol = 1 % Abafungin Product Code: N.A. Pharmaceutical Form: Cream Pharmaceutical form of the placebo: Cream Route of administration of the placebo: Topical use (Noncurrent) Product Name: 1 % Clotrimazol Product Code: N.A. Pharmaceutical Form: Cream CONDITION: Patients with tinea pedis interdigitalis PRIMARY OUTCOME: Main Objective: To compare the efficacy of Abafungin cream 1.0 %, the Vehicle to Abafungin cream and Canesten® cream (Clotrimazole 1 %) applied once daily for 4 weeks in the treatment of patients with interdigital tinea pedis. Primary end point(s): The primary efficacy endpoint for comparisons of treatment efficacy will be the rate of Effective Treatment at day 43, defined as proportion of patients achieving negative mycology, negative KOH test, and a Physician’s Global Assessment Score of 1 or 2. ; Secondary Objective: ‐ INCLUSION CRITERIA: · man or woman aged 18 to 75 years; · presence of interdigital tinea pedis caused by dermatophytes on one or both feet, characterized by clinical evidence of involvement of more than one interdigital space and at least moderate erythema (at least score 2), and moderate scaling (at least score 2); · a confirmatory microscopic demonstration of fungal elements; · the physical examination must be without other disease findings unless the investigator considers an abnormality to be irrelevant to the outcome of the study; · sexually active females of childbearing potential should use a medically accepted contraceptive regimen: systemic contraceptive (oral, implant, injection), diaphragm with intravaginal spermicide, cervical cap, intrauterine device (IUD), condom with intravaginal spermicide, or be surgically sterile (hysterectomy or tubal ligation); · written informed consent obtained. Are the trial subjects under 18? no Number of subjects fo