E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Distal subungual onychomycosis (DSO) |
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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 study is to evaluate the efficacy of topical Kaprolac® K70 in adults with distal subungual onychomycosis with a target nail involvement of ≤ 50% at baseline compared to placebo after 6 months treatment +2 weeks washout.
The primary efficacy variable is the proportion of patients with mycological cure (defined as negative fungal culture and negative direct microscopy) at 6 months treatment +2 weeks washout. |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives are to evaluate the efficacy of Kaprolac® K70 compared to placebo separately in patients with a target nail involvement of ≤ 50% and in patients with an involvement of 51-75% at baseline. Safety and tolerability of Kaprolac® K70 will be assessed in all patients together irrespective of target nail involvement at baseline. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
·Male or female (including fertile women) ·18 years or older ·Distal subungual onychomycosis of finger(s) and/or toe(s) affecting ≤ 75% of the nail bed ·Positive culture for dermatophytes (Trichofyton species i.e. T. rubrum or T. mentagrophytes) ·Signed written informed consent
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E.4 | Principal exclusion criteria |
·Proximal subungual onychomycosis ·Distal subungual onychomycosis of finger(s) and/or toe(s) where involvement has extended into the proximal portion of the nail, or distal subungual onychomycosis of finger(s) and/or toe(s) affecting >75% of the nail bed ·Conditions known to cause abnormal nail appearance ·Topical treatment of the nails with other antifungal medication within 1 month before screening ·Systemic use of antifungal treatment within 3 months before screening ·Signs of severe peripheral circulatory insufficiency ·Immunosuppression ·Participation in another clinical nail study during the previous 3 months ·Known allergy to any of the tested treatment products or to surgical tape occlusion
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary objective of the study is to evaluate the efficacy of topical Kaprolac® 70 in adults with distal subungual onychomycosis with a target nail involvement of ≤ 50% at baseline compared to placebo after 6 months treatment +2 weeks washout.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Yes |
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 | 70 |
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 | 1 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | |