Herpes Labialis MedDRA version: 8.1 Level: LLT Classification code 10019942 Term: Herpes labialis
Conditions
Interventions
Trade Name: Zovir creme 5%
Pharmaceutical Form: Cream
Sponsors
Johnson & Johnson Consumer and Personal Products Worldwide
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: Safety/tolerability, compliance, and treatment use information will also be assessed.;Primary end point(s): The primary endpoint will be the subject’s global assessment rated at the end of therapy. | — |
Countries
Denmark
Outcome results
None listed