E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Herpes Simplex Labialis on the perioral area |
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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 |
The primary objective of the study is to demonstrate that the new topical formulation of acyclovir 5% gel (Acyclovir Liquipatch) is more effective than the acyclovir 5% cream formulation in time to healing of lesions of Herpes Simplex Labialis. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives of the study are: To assess the efficacy of the two investigational medicinal products (IMPs) on extension of lesions, staging of lesions, and intensity of itching; To assess the local tolerability and general safety of the two IMPs. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Written informed consent obtained, 2. Patients of either sex aged > 18 and ≤ 70 years; 3. Patients in good general health conditions; 4. Patients with recurrent Herpes Simplex labialis infections; 5. Patients with clinically diagnosed Herpes Simplex labialis on the perioral area and burning symptoms started ≤ 24 hours; 6. Female subjects of childbearing potential (i.e., not status post hysterectomy or tubal ligation) must be using an appropriate method of contraception (implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner) and must be willing to continue using it throughout the entire study period; 7. Female subjects of childbearing potential must have a negative urine pregnancy test at the baseline visit; 8. Patients co-operative attitude and able to understand and adhere to study protocol procedures and timelines. |
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E.4 | Principal exclusion criteria |
1. Patients with diseases requiring systemic or topical corticosteroids; 2. Concomitant use of other anti-herpetic/antiviral drugs; 3. Concomitant use of anti-inflammatory medications or analgesics; 4. Concomitant use of any other drug administered as ointment, cream or gel, dermatological products, emollients, in the area of herpes labialis lesions; 5. Immunocompromised patients; 6. Patients with herpetic stomatitis (first infection); 7. Patients with Herpes labialis severe symptoms or signs of more 24 hours in duration, intraoral lesions, or lesions within the nares; 8. Patients with lesions wider than 2.0 cm2; 9. Traumatic loss of first crust; 10. Patients affected by severe renal, dysmetabolic or hepatic failure, which represent a risk to the subjects; 11. Presence of underlying medical conditions that might interfere with study completion; 12. Allergy, sensitivity or intolerance to study drug and/or study drug formulation ingredients; 13. History of alcoholism, drug abuse, psychological or other emotional problems that could invalidate informed consent or limit the subject compliance with protocol requirements; 14. Breastfeeding females; 15. Necessity to have a concomitant therapy with any drug mentioned in the restrictions. 16. Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study; 17. Patients who received any investigational drug within the last 12 weeks; 18. Patients who have been previously enrolled in this study; 19. Employees of the investigator or study centre (i.e., principal investigator, sub-investigator, study coordinators, other study staff, employees, or contractors of each), with direct involvement in the proposed study or other studies under the direction of that investigator and/or study centre, as well as family members of the employees or the investigator. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Time to healing, defined as the rate of patients with complete non-traumatic loss of the first hard crust (residual erythema can be present after loss of hard crust) at any follow-up visit, as assessed by the external observer. |
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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 | 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 | Yes |
E.8.1.3 | Single blind | No |
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 | No |
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 | 5 |
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial months | 9 |