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

Evaluation of Cold Sore Treatments on UV Induced Cold Sores

The purpose of this study is to determine if a new drug treatment is effective to block the development of a cold sore lesion following Ultra Violet (UV) exposure.

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.