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 | 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 |
The primary objective of this study is to evaluate and compare the efficacy of Compeed® Cold Sore Patch to Zovirax® Cream 5% in the treatment of herpes labialis. |
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E.2.2 | Secondary objectives of the trial |
Safety/tolerability, compliance, and treatment use information will also be assessed. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Male or female, 18 years of age or older and in good general health • History of recurrent herpes labialis (HSV-1) on the lips and/or perioral skin, with lesions typically manifesting as classical lesions (i.e., episodes progressing to vesicle, ulcer, and/or crust stages). Based on history, subject is considered likely to experience a cold sore outbreak within a time period of 3-4 months • Has treated prior outbreaks of herpes labialis with acyclovir or other cold sore therapy • Willing to stop all other treatment of this condition during the test period, including creams, tablets and other treatments. • Agrees not to use any topical product (e.g., cosmetics, lip balms, sunscreens) on the lesion area other than study medication • Agrees not to use any analgesics or anti-inflammatory agents during the treatment period • If sexually active female of childbearing potential, must be practicing an effective method of birth control (e.g., oral contraceptives, intrauterine device, male partner sterilization, double-barrier method) before enrollment and throughout the study • Signed an informed consent form indicating they understand the purpose of and procedures required for the study and are willing to participate in the study.
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E.4 | Principal exclusion criteria |
• History of diabetes mellitus • History of viral infection (e.g., hepatitis, HIV) or other condition likely to require treatment with systemic antiviral or steroid medications during the period of the study • History of dermatologic or other condition(s) that in the judgment of the investigator may affect the course of the cold sore lesion or interfere with the actions of the study treatment or confound the interpretation of the study results • Systemic antiviral or steroid therapy within past 30 days • Known allergy to any of the ingredients in the Compeed Cold Sore Patch or Zovirax Cream • Known alcohol or drug abuse • Participation in any other clinical study within the past 30 days • Is pregnant or actively breast-feeding, or plans to become pregnant during the time period of the study. • Employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, 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) |
The primary endpoint will be the subject’s global assessment rated at the end of therapy. |
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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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | No |
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
| 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 | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 2 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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 | 5 |
E.8.9.1 | In the Member State concerned days | 15 |
E.8.9.2 | In all countries concerned by the trial months | 5 |
E.8.9.2 | In all countries concerned by the trial days | 15 |