Tinea pedis interdigital
Conditions
Interventions
Product Name: Abafungin cream 1.0 %
Pharmaceutical Form: Cream
Sponsors
YORK Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - caucasian male and female patients - 18 to 75 years of age - 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 - female patients of childbearing potential agree to undergo pregnancy tests and to use an appropriate method of contraception (i.e. oral contraceptive steroids, intrauterine device, barrier method) - findings within the range of clinical acceptability in medical history and physical examination, and laboratory results within the “normal ranges” for the relevant laboratory tests (unless the clinical investigator considers the deviation to be irrelevant for the purpose of the study). Normal ranges are included in Appendix III - normal ECG and vital signs, or abnormalities which the clinical investigator does not consider a disqualification for participation in the study - willingness to undergo a pre-study physical examination and pre- and post-study laboratory investigations - ability to comprehend and willingness to sign both statements of informed consent (for screening and phase-related procedures). 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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. • Positive testing for HIV, HBsAg, or HCV. • Positive urine screen for drugs of abuse. • Do not tolerate vein puncture.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Presently it is not known whether or not abafungin will be percutaneously absorbed and reach systemic circulation after topical dermal application on damaged skin. In previous single dose and multiple dose (7 treatment days) phase I studies in healthy volunteers abafungin could not be detected in plasma or urine. In this study the percutaneous absorption of abafungin will be investigated after topical dermal application of a cream formulation (Abafungin cream 1.0 %) in patients with tinea pedis interdigitalis. About 0.5 g cream formulation will be applied on the foot/feet over a period of 15 days. ;Secondary Objective: ;Primary end point(s): Pharmacokinetic parameters Primary variables: - plasma concentrations of abafungin; plasma concentrations will be evaluated descriptively. Efficacy variables: - clinical cure on study day 15 - patient’s assessment of pruritus/burning (0,1,2,3) on study days 1 and 15 - physician's assessment of signs and symptoms on study days 1 and 15 (i.e., the overall severity of each sign and symptom [0,1,2,3]: erythema, scaling, vesicles, pustules, crusting, fissuring and maceration). - the Physician’s Global Assessment Score (1, 2, 3, 4) on study days 1, 15 - the Physician’s assessment of overall efficacy and tolerability (0, 1, 2, 3, 4) at the final visit | — |
Countries
Hungary
Outcome results
None listed