E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Herpes Simplex Labialis (HSL) |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10019942 |
E.1.2 | Term | Herpes labialis |
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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 |
Primary objective of this study is to investigate the efficacy of repeated topical applications of brivudin cream 0.5% and 1.0% versus placebo cream in the treatment of HSL as measured by the duration of the HSL episode, defined as time from start of treatment to: a) Complete loss of hard crusts in classical HSL lesions. b) Time to resolution of sign(s) and symptom(s) in aborted lesions (defined as lesions not developing beyond the papula stage).
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E.2.2 | Secondary objectives of the trial |
Secondary objectives of the study include the following evaluations: a) The efficacy of brivudin cream 0.5% and 1.0% as measured by: The occurence/proportion of aborted lesions (defined as lesions not developing beyond the papule stage). Time to complete resolution of pain and/or discomfort. Time to resolution of all sign(s) and symptom(s). b) The potential for systemic absorption of BVDU after repeated topical applications of brivudin cream 0.5% and 1.0% (pharmacokinetic measurement of BVDU and BVU plasma levels will be performed at baseline and after 4 days of treatment). c) The potential inhibition of DPD enzyme activity after repeated topical applications of brivudin cream 0.5% and 1.0% (measurement of DPD activity will be performed at baseline and after 4 days of treatment). d) The safety and tolerability of brivudin cream 0.5% and 1.0%.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Male and female Caucasian otherwise healthy HSL patients, >= 18 years of age. • Clinically diagnosed HSL lesion meeting the following criteria: a) Early lesion stage, i.e. prodromi, erythema, papule, or the vesicular stage (within 48 hours after onset of the first sign and/or symptom). b) Location on the lips, the vermilion border, or the perioral skin. • Willingness to avoid use of topical perioral protectants, lip balms, cosmetics, and over-the-counter products (OTC) or prescription treatments for cold sores during the study. • Written informed consent. |
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E.4 | Principal exclusion criteria |
• Evidence of congenital, acquired, or drug-induced immuno-deficiency including any malignancy. • History of allergy or hypersensitivity to brivudin. • Any use of local or systemic antivirals or immune-modifying therapy (e.g. corticosteroids, anticancer drugs) within 3 weeks prior to start of treatment. • History of congenital or acquired DPD deficiency. • History of complications of herpes simplex infection including central nervous system and ophthalmologic complications, visceral or cutaneous dissemination. • Patients considered unreliable or unable to follow protocol requirements. • Concomitant diseases which could have a relevant impact on study results. • Pregnancy or lactation in female patients. • Participation in other clinical trials within 4 weeks before enrolment. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Duration of the HSL episode defined as time from start of treatment to: a) complete loss of hard crusts in classical HSL lesions and b) time to resolution of sign(s) and symptom(s) in aborted lesions (defined as lesions not developing beyond the papule stage).
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
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) | Yes |
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 |
Clinical phase I/II Study |
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E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 1 |
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 | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | 25 |
E.8.9.2 | In all countries concerned by the trial days | 25 |