Evaluation of Cold Sore Treatments on Ultra Violet (UV) Induced Cold Sores

This was a multi-center, randomized, evaluator and subject-blind, placebo controlled study
design

The objective of this study was to evaluate the ability of the test articles to block the
development of a cold sore lesion from progressing beyond the prodromal stage following a
UV-induced process.

The primary efficacy endpoint of this study was to determine if a recurrent oral herpes
episode initiated with prodromal symptoms was aborted before progressing to a lesion
(vesicle) via assessing lesion stages by a trained evaluator.

The secondary efficacy endpoints included: a) subject self-assessments and b) test article
weights and diaries to track treatment compliance.

Inclusion Criteria:

- Clinical history of recurrent cold sores averaging 2 or more episodes per year

- UV exposure is known to cause a cold sore outbreak

Exclusion Criteria:

- History of abnormal reactions to sunlight

- Used antiviral therapy directly prior to entering study

- Any other condition which in the opinion of the Investigator may affect the results
or place the subject at undue risk.