E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Mild to moderate distal subungual Onychomycosis caused by Dermatophytes |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10030338 |
E.1.2 | Term | Onychomycosis |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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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 evaluate the efficacy of P-3058 in the treatment of onychomycosis. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the overall safety and the tolerability of P-3058. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) Written informed consent before starting any study related procedures.
2) Patients aged 12 years and older of any race.
3) Males or females.
4) Outpatients.
5) Clinically diagnosed mild-to-moderate distal lateral subungual onychomycosis (DLSO) of at least one big toenail (the "target nail") at the Screening visit (V1), confirmed by the Independent Panel of Reviewers.
6) Patients with onychomycosis involving ≥ 20% to ≤ 50% of the area of the target big toenail.
7) Patients with a positive KOH examination in the screening target big toenail sample.
8) Patients with positive culture for dermatophyte(s) or positive mixed dermatophyte(s)/Candida culture in the screening target big toenail sample.
9) Evidence of target big toenail growth reported by the patient defined as at least monthly nail clipping.
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E.4 | Principal exclusion criteria |
- Woman who is pregnant, nursing an infant, or planning a pregnancy during the study period.
- Presence of “yellow spikes” (defined as longitudinal streak extending from the free edge of the nail to the proximal edge) on the target nail.
- Presence of dermatophytoma (defined as thick masses of fungal hyphae and necrotic keratin between the nail plate and nail bed) on the target nail.
- Presence of nail thickness exceeding 2 mm.
- 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, lichen planus, immune dysfunction, collagen-vascular diseases, peripheral vascular disease.
- Patients with life expectancy less than 2 years.
- Chemotherapy, immunosuppressive therapy in the 12 weeks prior to Screening visit (V1).
- Systemic corticosteroids, antimetabolites and immune-stimulants therapy in the 4 weeks prior to Screening visit (V1).
- HIV infection or any other immunodeficiency.
- Alcohol or substance abuse.
- Patients with history of allergic reactions to terbinafine or amorolfine or to their excipients. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Complete cure rate defined as composite of negative KOH microscopy and negative culture for dermatophytes and no residual clinical involvement. |
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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) |
• Responder rate.
• Negative culture rate.
• Mycological cure.
• Overall safety and local tolerability during the entire study. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | 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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
P-3058 Vehicle, P-3058 identical nail solution without active and amorolfine 5% nail lacquer |
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E.8.2.4 | Number of treatment arms in the trial | 3 |
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 | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 96 |
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 |
Belgium |
Bulgaria |
Czech Republic |
Germany |
Greece |
Hungary |
Iceland |
Latvia |
Lithuania |
Poland |
Russian Federation |
Slovakia |
Sweden |
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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 end of the trial corresponds to the last visit performed by the last patient included in 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 | 1 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 1 |