Randomized Clinical Study Comparing Compeed Cold Sore Patch to Zovirax Cream 5% in the Treatment of Herpes Labialis

Active, not recruiting

• Conditions: Herpes Labialis; MedDRA version: 8.1Level: LLTClassification code 10019942Term: Herpes labialis

• Registration Number: EUCTR2006-004015-21-DK
• Lead Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08-10
• Last Update Posted: 2012-03-19

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 300

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

•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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified