Oral Herpes Simplex Clinical Trial
Official title:
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01308424 -
Safety and Efficacy Study of a New Treatment for Recurrent Symptoms of Oral Herpes Virus Infection
|
Phase 1/Phase 2 |