patients
Conditions
Interventions
Product Name: Abasol® (for formulation (1) = 1 % Abafungin-cream
Product Code: N.A.
Pharmaceutical Form: Cream
INN or Proposed INN: Abafungin
CAS Number: 129639-79-8
Current Sponsor code: BAY w 6341
C
Sponsors
York Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: • received treatments like foot or shoe powders, pharmaceutic 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 of the baseline visit; • receiving potassium permanganate drugs either concurrently or within 1 week of the baseline visit; • use of antibacterial, antiviral or antihelminthic drugs; • 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; • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of Abafungin cream 0.2 %, Abafungin cream 1.0 %, Abafungin cream 2.0 % and vehicle to Abafungin cream, applied once daily for 4 weeks in patients with interdigital tinea pedis.;Secondary Objective: __;Primary end point(s): Primary variable for the statistical analysis is the treatment success rate after 6 weeks (2 weeks post-treatment, “Point of Cure”). Treatment success is defined as: 0 (no treatment success) = the patient is not completely cured* or effectively treated** 1 (treatment success) = the patient is completely cured* or effectively treated** * Completely cured are patients who are: 1. mycologically cured*** and 2. have a physicians global assessment score of 1, i.e. clinical cure / clear and 3. have a score of 0 (absent, normal) for all signs and symptoms ** Effectively treated are patients who are: 1. mycologically cured*** and 2. have a physicians global assessment score of 2, i.e. clear or almost clear and 3. have a score no greater than 1 (mild, barely abnormal) for erythema, no greater than 1 (mild, barely abnormal) for scaling and not greater than 0 (absent, normal) for all other signs and symptoms *** Mycological cure is defined as: 0 (no mycological cure) = positive microscopy or positive culture 1 (mycological cure) = both, negative microscopy and negative culture simultaneously | — |
Countries
Germany
Outcome results
None listed