E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
distal subungual onychomycosis without lunula involvement due to fungal nail pathogens (dermatophytes, white yeasts and/or Scopulariopsis spp. and/or Fusarium spp.) affecting at least one big toenail |
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E.1.1.1 | Medical condition in easily understood language |
toenails with clinical signs of mycosis |
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E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
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 evaluate the conversion to negative of culture of treatment with Ciclopoli® vs Loceryl® .
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E.2.2 | Secondary objectives of the trial |
To evaluate the conversion to negative of culture at week 4 and 8, 24 and 48. To evaluate the conversion to negative of KOH microscopy at week 4, 8, and 12, 24 and 48. To evaluate the clinical signs of onychomycosis at week 4, 8, and 12, 24 and 48. Responders rate at week 12, 24 and 48, defined as patients with conversion to negative of culture and of microscopic KOH examination and with decrease of affected nail area to ≤10% of total. Complete cure rate at week 12, 24 and 48 defined as complete replacement of the affected nail by new healthy nail, accompanied by conversion to negative of culture and of microscopic KOH examination). To evaluate the overall safety and local tolerability. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Written informed consent before starting any study related procedures Patients aged 18 up to 75 years old Males or females Patients with established clinical diagnosis of distal sub-ungual onychomycosis caused by fungal nail pathogens, affecting at least one big toenail with indication for topical treatment Patients with both positive KOH and culture for fungal nail pathogens (dermatophytes, white yeasts and/or Scopulariopsis spp. and/or Fusarium spp.) in screening target nail sample.
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E.4 | Principal exclusion criteria |
Patients with "Yellow spikes" on the target nail (extension of fungal infection from distal to proximal part of nail) Patients with lunula involvement (marker of immunosuppressed patient) Patients with negative KOH examination at screening Patients with proximal subungual involvement (marker of immunosuppressed patient) Patients with severe plantar or moccasin tinea pedis (defined by blistering, pustules or inability to ambulate) Patients with nail abnormalities due to conditions like psoriasis or lichen planus Patients using nail polish or other nail cosmetic product on the concerned nails from at least 24 hours prior to study drug administration until the end of the study. Patients with target nail hyperkeratosis exceeding 4 mm in thickness Use of any topical antifungal drugs (including investigational drug) or participation in an investigational study within 30 days prior to administration of study medication
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E.5 End points |
E.5.1 | Primary end point(s) |
Conversion to negative of culture. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Conversion to negative of culture evaluated at 4, and 8, 24 and 48 weeks Conversion to negative of microscopy (KOH), monitored at 4, 8, and 12, 24 and 48 weeks. Determination of nail infected area at weeks 4, 8 and 12, 24 and 48 compared to baseline Determination of growth rate of healthy nail at weeks 4, 8, and 12, 24 and 48. Responders rate at week 12, 24 and 48 defined as patients with conversion to negative of culture and of microscopic KOH examination and with decrease of affected nail area to ≤10% of total Complete cure rate at week 12, 24 and 48 defined as complete replacement of the affected nail by new healthy nail, accompanied by conversion to negative of culture and of microscopic KOH examination). Overall safety evaluation |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
4, 8, 12, 24 and 48 weeks |
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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 | 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 | 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 | Yes |
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 | No |
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 | Yes |
E.8.2.3.1 | Comparator description |
Loceryl medicated nail laquer |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
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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it is last patient last visit |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
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 |