E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Mild to moderate onychomycosis of fingernail(s) or toenail(s) |
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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 | 10030338 |
E.1.2 | Term | Onychomycosis |
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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 |
The primary objective of the trial is to demonstrate superiority of bifonazole vs. placebo after 28 days of onychomycosis treatment as a follow-up of non-surgical nail ablation with a 40% urea paste over 14 days (in rare cases up to 28 days) by assessing complete cure (mycological and clinical cure) 2 weeks after the end of treatment (visit 3) |
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E.2.2 | Secondary objectives of the trial |
The secondary objective of the trial is to compare safety and tolerability of bifonazole vs. placebo with respect to the incidence of adverse events (AEs) during the trial. In addition, clinical signs and symptoms and mycological culture and microscopy will be assessed 2 weeks after the end of treatment (visit 3), as well as 3 months (visit 4) and 6 months (visit 5) after the end of treatment. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•Age of at least 18 years;
•Positive clinical findings of onychomycosis according to the judgement of the investigator (e.g. thickening, discoloration, structural changes, misshaped nails);
•Positive mycological findings (positive microscopy and positive culture with identification of pathogen) in material taken from affected nail sites before the start of treatment;
•Nail mycosis with an affected nail area between 20% and 50% in the target nail;
•Nail mycosis in not more than 3 nails (each nail not more than 50% infected area);
•Willingness and ability to understand and adhere to the trial procedures;
•Provide a personally signed and dated informed consent indicating that the subject has been informed of all pertinent aspects of the trial;
•Subjects of childbearing potential must use an acceptable method of contraception. Hormonal or oral contraceptive drugs, intra-uterine devices (IUD) and abstinence are considered acceptable methods of contraception.
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E.4 | Principal exclusion criteria |
Doubtful or negative mycological findings;
•Proximal subungual onychomycosis (PSO);
•Topical antimycotic treatment of feet or hands within 4 weeks prior to screening, topical treatment of onychomycosis of feet or hands within 12 weeks prior to screening;
•Systemic antimycotic treatment within 12 weeks prior to screening;
•Failure to treat tinea pedis/manus (diagnosed at screening) successfully with topical treatment between screening visit and visit 1 (baseline);
•Tinea pedis/manus at visit 1 (baseline);
•Uncontrolled diabetes mellitus;
•Psoriasis;
•Peripheral arterial disease;
•Chronic venous insufficiency;
•Diabetic neuropathy;
•Multi-morbidity;
•History of hypersensitivity to bifonazole, or any other similar pharmacological agents or components of the products;
•Known sensitivity to plasters;
•Intake of drugs interfering with the immune system (e.g. corticosteroids, immunosuppressants) within 30 days before as well as intended use during the trial;
•Any type of immunosuppressive disorder;
•All infectious diseases which require systemic antimicrobial/antiviral therapy (e.g. hepatitis, AIDS);
•Any reason that speaks against trial participation in the opinion of the investigator;
•Participation in a clinical trial within the last 30 days prior to enrollment;
•Prior participation in this trial;
•Pregnancy or breast-feeding;
•Incapability of understanding the language in which the information for the subject is given;
•Legal incapacity and/or other circumstances rendering the subject unable to understand the nature, scope and possible consequences of the trial;
•Presence or history of drug or alcohol abuse;
•Presence of malign diseases during the past 5 years;
•The subject is the investigator him/herself, investigator’s family members and employees;
•Employees of sponsor/CRO.
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E.5 End points |
E.5.1 | Primary end point(s) |
Overall cure rate comprising clinical cure and mycological cure rate (microscopy + culture negative) assessed 14 days after the end of treatment (V3). The primary endpoint will be analyzed in a confirmatory manner using two-sided Fisher’s exact test at the significance level of 0.05.
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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 | 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) | 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.8.4.1 | Number of sites anticipated in Member State concerned | 29 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 50 |
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 follow-up visit (visit 5; 6 months after end of treatment) of 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 | 3 |
E.8.9.1 | In the Member State concerned days | |
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 | 3 |