Comparative Safety and Efficacy of Two Antiviral Treatments in the Treatment of Recurrent Herpes Simplex Labialis

Inclusion Criteria:

1. Provides written informed consent/assent

2. Immunocompetent male or non-pregnant females, >12 years old, with limited,
non-life-threatening, recurrent herpes simplex labialis.

3. Subjects must have at least 3 recurrences of herpes simplex labialis per year for the
past two years.

4. Females of childbearing potential willing to use an acceptable form of birth control.

5. Subjects must be in general good health with no clinically significant disease that
might interfere with the study evaluations in the opinion of the investigator.

6. Subjects must be willing and able to understand and comply with the requirements of
the study.

Exclusion Criteria:

1. Females who are pregnant or nursing, are not using or does not agree to use an
acceptable form of contraception during the study, or who intends to become pregnant
during the study.

2. The use of antiviral therapies in various forms for a given period of time prior to
screening and study medication application.

3. Candidate for or previous use of parenteral antiviral treatment or prophylactic
antiviral therapy for their recurrent herpes simplex labialis.

4. Recently received an organ transplant.

5. Subjects who are immunocompromised, HIV positive or who have any immune-system
disorders.

6. Recent major change in immune system status that could seriously affect the clinical
manifestations of herpes simplex labialis and need for treatment in the opinion of
the investigator.

7. Subjects with known or suspected history of a clinically significant systemic
disease, unstable medical disorders, life-threatening disease or current
malignancies.

8. Subjects with a current episode of herpes simplex labialis that has not completely
healed.

9. Presence of any facial skin condition or excessive facial hair that may interfere
with diagnosis, assessment, and/or healing ability.

10. History of herpes keratitis.

11. Subject has a history of hypersensitivity or allergy to any ingredient in the drug
product.

12. History of unresponsiveness to topical acyclovir therapy.

13. Participation in any other clinical study or who have received treatment with any
investigational drug or device within 30 days prior to screening.

14. Subjects who have previously enrolled in this study.

15. Subjects who have received any local medication in the target area during the 2 weeks
prior to both enrollment/screening and Day 1 (Visit 2).

16. Subjects who have been treated with immunosuppressive medication therapy within 8
weeks prior to the study both enrollment/screening and Day 1 (Visit 2).

17. Subject consumes excessive alcohol, abuses drugs, or has a condition that could
compromise the subject's ability to comply with study requirements in the
investigator's opinion.

18. Use of tanning booths, sun lamps, or excessive exposure to the sun for up to 21 days
from initiating study medication

19. Subjects using immunostimulators, dye-light therapy, or psoralen therapy within 30
days prior to study medication initiation