E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
For the treatment of tinea pedis |
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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 determine whether ketoconazole 2% cream (F126) is non-inferior to Nizoral® cream (F012) in effecting mycological cure (MC) following 4 weeks of treatment, following determination of superiority of both active treatment arms to placebo, in the treatment of symptomatic uncomplicated interdigital Tinea pedis. MC is defined as negative Potassium Hydroxide (KOH) microscopy and mycological culture and will be assessed at week 6. |
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E.2.2 | Secondary objectives of the trial |
To compare the overall cure (OC) of ketoconazole 2% cream (F126) and Nizoral® cream (F012), versus placebo (F000) at 6 weeks following a 4-week treatment regimen in the treatment of symptomatic uncomplicated interdigital Tinea pedis. Overall cure is defined as MC in addition to a global clinical evaluation of either ‘Completely cleared’ or ‘Marked Improvement’ (assessed at Week 6). To study the safety and tolerability of ketoconazole 2% cream (F126) in this subject population. To determine systemic exposure to ketoconazole following topical application of ketoconazole 2% cream (F126) and Nizoral® cream (F012).
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or female subjects aged 18 years or more. 2. Subjects must be co-operative, reliable and sufficiently competent to grade and record symptoms as requested. 3. Clinical diagnosis of uncomplicated interdigital Tinea pedis confirmed by KOH microscopy. 4. Female subjects must be, surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study; have a negative urine pregnancy test at screening. 5. Willing to adhere to the prohibitions and restrictions specified in this protocol. 6. Subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
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E.4 | Principal exclusion criteria |
1. Complicated Tinea pedis defined as: Confluent, diffuse moccasin type tinea pedis of the entire plantar surface, onychomycosis; other dermatomycosis requiring active treatment. 2. Subjects with a previous sensitivity to imidazole antifungal agents or to any ingredient of the study medication. 3. History of disallowed therapies: history of oral antifungal treatments within the previous 6 weeks; recent use (within two weeks of the study start) of topical antifungal agent; immunosuppressive or radiation therapy within the previous four weeks; recent use (within two weeks prior to screening) of other oral antibiotics, systemic corticosteroids or topical corticosteroids or antibiotics applied to the feet. 4. Recent history of drug or alcohol abuse, psychosis, or other condition making the subject unlikely to comply with the protocol. 5. Known HIV-positive (testing will not be performed). 6. Uncontrolled diabetes mellitus or peripheral vascular disease requiring active treatment. 7. Clinically relevant abnormal findings on clinical examination of the feet. 8. Any subject in whom skin scraping would be considered contraindicated. 9. Have received an experimental drug or used an experimental medical device within 30 days prior to the study or within five half-lives of the investigational drug, whichever is longer. 10. Is pregnant or breast-feeding. 11. Employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy endpoint is to assess the percentage of patients achieving mycological cure (defined as both KOH microscopy and mycological culture negative) of interdigital Tinea pedis following 4 weeks of treatment. This will be assessed at week 6 (2 weeks after active treatment has stopped). In support of the mycological cure, the clinical efficacy of the therapy will also be assessed. This will be determined by examination of the change in overall score of clinical signs and symptoms and by a global evaluation of the therapy. The change in the overall score of clinical signs and symptoms from baseline measures will be assessed at each visit and at follow-up. |
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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 | Yes |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
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 | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 8 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 21 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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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The study is considered completed with the last visit of the last subject undergoing the study |
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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 | 22 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 22 |