E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10043873 |
E.1.2 | Term | Tinea pedis |
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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 |
Comparison of the efficacy and tolerability of the new preparation Terbinafine Creme 1% vs. the approved preparation Lamisil(R) vs. vehicle in patients with Tinea pedis.
Primary efficacy variable: Proportion of patients with clinical and mycological treatment success at study end (day 21). |
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E.2.2 | Secondary objectives of the trial |
Secondary efficacy variables: Proportion of patients with clinical and mycological treatment success at the end of the treatment phase (day 7) Change of the sum of scores of the symptoms pruritus, erythema, desquamation, exudation, blisters and pustules between day 0 and day 7 as well as between day 0 and day 21 Change of the scores of the individual symptoms pruritus, erythema, desquamation, exudation, blisters and pustules between day 0 and day 7 as well as between day 0 and day 21 Proportion of patients with mycologically successful treatment at day 7 and at day 21 Proportion of patients with clinically successful treatment at day 7 and at day 21 Proportion of patients with relapse at day 21 Global evaluation of the therapeutic success in the test area by investigator and patient at day 7 and at day 21
Safety Global evaluation of tolerability by investigator and patient at day 7 Adverse Events |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
males and females of at least 18 years of age written informed consent after being verbally informed by the investigator diagnosis of Tinea pedis interdigitalis confirmed by a positive microscopical native preparation with 30% caustic potash at least moderate severity of skin infection, i.e. patients must have score value of at least 4 (=sum score of the clinical parameters pruritus, erythema, desquamation, exudation, blisters and pustules, each rated on a scale of 0 to 3) Women of childbearing potential: Use of a highly effective contraception method for the duration of the study Women of childbearing potential: Negative pregnancy test prior to treatment start |
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E.4 | Principal exclusion criteria |
topical treatment with antimycotic preparations in the test area during the 7 days prior to study inclusion systemic treatment with antimycotic preparations during the 4 weeks prior to study inclusion known intolerance of or hypersensitivity to terbinafine or any other ingredient of the study medication severe heart failure or circulatory failure, severy hepatic or renal insufficiency, severe respiratory insufficiency, neoplasm severe acute or chronic concomitant disease seriously affecting the general condition concomitant diseases which may -taking the present knowledge into account- influence the parameters assessed in the study in a way that would make an objective evaluation impossible concomitant medication which may -taking the present knowledge into account- influence the methods of measurement used in this study or the resulting data well-founded doubt regarding the cooperation of the patient dementia or any other severe intellectual impairment which makes a sound assessment of the patient history or a sound self-assessment impossible excessive consumption of alcohol, illegal drugs, medicaments or nicotine participation in another clinical trial within 30 days prior to inclusion or during this study former participation in this clinical trial pregnancy, lactation |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary efficacy variable: Proportion of patients with clinical and mycological treatment success at study end (day 21). |
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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 | No |
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 | No |
E.6.10 | Pharmacogenetic | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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) | Yes |
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.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
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 | No |
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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last visit of the last subject undergoing the trial |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |