E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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. |
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | 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
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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End of study = date of last visit of last subject |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |