E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 | 10019948 |
E.1.2 | Term | Herpes simplex |
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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 assess the efficacy, local tolerability and safety of a new topical formulation of acyclovir 5% gel (MILP-01), in comparison with acyclovir 5% cream for the treatment of subjects affected by Herpes Simplex Labialis. |
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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 |
- Both sexes, all ethnic backgrounds, outpatients, between 18 and 70 years of age, in good general health. - Subjects with a diagnosis of Herpes Simplex Labialis. The diagnosis is based on a clinical evaluation. - Ability to understand and comply with the prescriptions contained in the therapeutic protocol. - Subjects who have given their written informed consent in accordance with provisions of the pertinent excerpt of the Declaration of Helsinki. |
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E.4 | Principal exclusion criteria |
- Subjects affected by diseases requiring the use of systemic or topical corticosteroids. - Concomitant use of other anti-herpetic/antiviral drugs - Concomitant use of anti-inflammatory medications or analgesics. - Concomitant use of any other drug administered as ointment, cream or gel, dermatological products, emollients, in the area of herpes labialis lesions. - Immunocompromised subjects. - Patients with herpetic stomatitis (first infection) - Patients with Herpes labialis severe symptoms or signs of more 24 hours in duration, intraoral lesions, or lesions within the nares. - Subjects with lesions wider than 2,0 cm2 - Traumatic loss of first crust - Subjects affected by severe renal, dismetabolic or hepatic failure which represent a risk to the subjects. - Presence of underlying medical conditions that might interfere with study completion. - Partecipation in any other study involving investigational or marketed products concomitantly or within one month prior to study entrance. - A history of alcoholism, drug abuse, psychological or other emotional problems that could invalidate informed consent or limit the subject compliance with protocol requirements. - breastfeeding females. - Necessity to have a concomitant therapy with any drug mentioned in the restrictions. - Subjects likely to be not compliant/uncooperative during the study, in the judgment of the clinical investigator. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary endpoint is the evaluation of clinical efficacy from baseline, at visit day 3, visit day 4 and/or visit day 5, visit day 10.
Trial efficacy primary endpoints will be: - the percentage of healed patients recorded within the 5th day of therapy;
Secondary end points: 1. Evaluation of clinical efficacy by: Time to healing 2.Evaluation of clinical symptomatology by: Staging of lesions (vesicular, pustular, ulcerative, crusted, healed); Itching (absent, mild, moderate, severe) Total lesion area at day 3-4 and/or 5-10 3. Evaluation of local tolerability from baseline. The drug local tolerability will be evaluated on symptoms and feelings reported by subjects and objective data obtained by researchers during treatment. It will be performed by: A. Investigator's assessment of skin irritation. B. Other local reactions. C. Local Side Effects Global Assessment. D. Investigator's Global Assessment of local tolerability. |
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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 | Yes |
E.7.1.3.1 | Other trial type description |
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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 | Yes |
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 |
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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.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 9 |
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 | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |