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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 375

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 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

·received treatments like foot or shoe powders, pharmaceutical and cosmetic topicals (e.g. creams/gels, except for washing products) or topical anti-fungal therapy of the feet within 30 days before study entry, oral antifungal therapies within three months before study entry (8 months for oral terbinafine), systemic antibiotic or corticosteroid treatment, topical corticosteroids within 30 days before study entry, radiation therapy and/or anti-neoplastic agents within one year before study entry;
·receiving systemic therapy with cytotoxic or immunosuppressive drugs either concurrently or within 12 weeks before the baseline visit;
·receiving potassium permanganate drugs either concurrently or within 1 week before the baseline visit;
·use of antibacterial, antiviral or antihelminthic drugs concurrently or within 2 weeks before the baseline visit.
·evidence of drug or alcohol abuse;
·pregnancy or nursing;
·have symptoms of a clinically significant illness, or known laboratory value deviation, that may influence the safety of the patient, or the outcome of the study in the 30 days before and during the study;
· are known to be immunodeficient;
·have symptoms of a diabetic foot or neuropathies at foot/feet;
·have foot psoriasis, corn and/or callus involving any interdigital web spaces, atopic or contact dermatitis;
·widespread dermatophytoses, plantar / moccasin type tinea pedis, hyperkeratotic tinea pedis, tinea pedis or systemic fungal infection requiring systemic treatment, onychomycosis, tinea corporis, tinea cruris or tinea capitis, mucocutaneous candidiasis or bacterial skin infection;
·participation in another clinical trial involving pharmaceutical products in the 30 days preceding the study and during the study;
·known allergic reactions or known hypersensitivity to components of the study medications;
·in the opinion of the investigator or physician performing the initial examination the patient should not participate in the study, e. g. due to probable noncompliance or inability to answer questions or to assess tolerability of the study drug or to understand the study and give adequately informed consent.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.;Secondary Objective: -;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. <br>

Secondary Outcome Measures

Name	Time	Method

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