E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 |
The objective of this study is to evaluate the safety of ME-609 for the treatment of herpes labialis recurrences in adolescents, 12 – 17 years of age.
For evaluation of safety, the following variables will be assessed: • Adverse events • Categorization of recurrence • Maximum lesion area assessment
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or female, 12 - 17 years of age at inclusion 2. General good health, as judged by the Investigator. 3. History of recurrent herpes labialis with at least two recurrences during the last twelve months, as based on an interview with the subject 4. Agreement to refrain from - Using other topical medical, over-the-counter (OTC), or cosmetic products in or around the oral area during the herpes recurrence - Mechanical disruption of the area affected by herpes labialis during the study recurrence 5. Subjects must themselves, and where appropriate their legally acceptable representative (as required by IRB/IEC and local legal requirements), voluntarily sign and date the informed consent |
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E.4 | Principal exclusion criteria |
1. Treatment with other systemic or topical antiviral agents within two weeks prior to inclusion 2. Treatment with systemic corticosteroids, or with topical corticosteroids in or around the oral area, within two weeks prior to inclusion 3. Any evidence of an immunosuppressed state of the subject due to underlying disease (e.g. HIV infection) or concomitant treatment (e.g. cancer chemotherapy) 4. Significant skin conditions that occur in the area typically affected by herpes recurrences, and that would interfere with assessment of lesions such as atopic dermatitis, acne, eczema, psoriasis, or chronic vesiculobullous disorders 5. Receipt of an investigational drug or immunomodulatory agent within two weeks prior to inclusion, or concurrent participation in another research study 6. History of immediate hypersensitivity or serum sickness reaction to any nucleoside analogue antiviral agent, or to any topical steroid, or to the vehicle 7. Nursing or pregnancy
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E.5 End points |
E.5.1 | Primary end point(s) |
• Adverse events
• Categorization of recurrence • Maximum lesion area |
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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 | No |
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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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 | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
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 | 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 | 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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The study will be regarded as complete as soon as 110 subjects have treated an episode of herpes labialis with study medication during the five-day treatment period, and completed the follow-up visit 3 weeks after end of treatment. Thus, the trial may be ended before all included subjects (i.e. subjects who have been dispensed study medication) have the opportunity to complete the trial (i.e. treat themselves and complet visit schedule). |
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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 | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |