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 |
To demonstrate the non-inferiority of MedSpray™ TP 1 % compared to Lamisil® Once 1 % as determined by the proportion of subjects categorised as successfully treated at week 1, as measured by the physician’s global assessment score for clinical signs and symptoms |
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E.2.2 | Secondary objectives of the trial |
• Assess tolerability of a single use of MedSpray™ TP 1 % (adverse events) • Assess recurrence / relapse rate following a single use of MedSpray™ TP 1 % • Assess consumer acceptability of a single use of MedSpray™ TP 1 %
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
All of the following criteria have to be met for inclusion of a subject in the study: • men and women aged 18 years or over; • presence of interdigital tinea pedis caused by dermatophytes on one or both feet, characterized by physician’s global assessment score of 2 (“notable signs and symptoms exist”) or 3 (“prominent signs and symptoms exist”) at baseline • the physical examination must be without other disease findings unless the investigator considers an abnormality to be irrelevant to the outcome of the study;
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E.4 | Principal exclusion criteria |
Patients are to be excluded from the study when one or more of the following conditions are met: • patients aged under 18 years; • patients with hyperkeratotic chronic plantar tinea pedis (moccasin type); • patients who are immunosuppressed (includes patients receiving radiation therapy or systemic therapy with cytostatic or immunosuppressive drugs at time of study or within the 2 weeks prior to entry); • patients who had active treatment in the last 2 weeks before entry, or are currently undergoing active treatment for another dermatomycosis with a drug other than the study drugs; • patients with diabetes; • patients with compromised circulation; • patients who have been treated with oral anti-fungal agents within the 12 weeks prior to study entry or treated with topical anti-fungal agents on the feet within the previous 2 weeks; • evidence of drug or alcohol abuse; • pregnancy or nursing; • symptoms of a clinically significant illness that may influence the outcome of the study in the four weeks before and during the study; • treatment with any other investigational drug in the four weeks preceding the study; • patients with known hypersensitivity to terbinafine or any of the test or comparator product excipients (see appendix A of study protocoll); • treatment with systemic or locally acting medications which might counter or influence the study aim within two weeks before the beginning of the study (e.g. antihistamines or glucocorticosteroids); • contraindications according to summary of product characteristics of Lamisil® Once or according to IB on MedSprayTM TP 1 %
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E.5 End points |
E.5.1 | Primary end point(s) |
Treatment success based on the Physician’s global assessment score (see section 6.3 of study protocol) at the week one follow up is the primary variable.
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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 | 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) | 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 | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
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 | 2 |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 6 |