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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
303
Sublingual micro dosing of placebo for 7 days
Sublingual micro dosing of BTL-TML-HSV for 7 days
Hill Top Research
St. Petersburg, Florida, United States
Hill Top Research
Cincinnati, Ohio, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, United States
Number of Participants for Whom a Recurrent Oral Herpes Episode Initiated With Prodromal Symptoms Were Aborted Before Progressing to a Lesion as Assessed by a Trained Evaluator
The primary efficacy endpoint of this study is to determine if a recurrent oral herpes episode initiated with prodromal symptoms is aborted before progressing to a lesion (vesicle stage) via assessing lesion stages by the trained evaluator. Any episode of oral herpes that did not reach a vesicle stage or higher by Day 7 (based on evaluator and self-assessments of legion stage) was considered "aborted" or "blocked". Any episode of oral herpes that reached a vesicle stage or higher by Day 7 was considered a treatment failure.
Time frame: Day 0- Day 7
Number of Participants for Whom a Recurrent Oral Herpes Episode Initiated With Prodromal Symptoms Were Aborted Before Progressing to a Lesion as Assessed by the Participant
The secondary efficacy endpoint of this study is to determine if a recurrent oral herpes episode initiated with prodromal symptoms is aborted before progressing to a lesion (vesicle stage) via assessing lesion stages by the participant. Any episode of oral herpes that did not reach a vesicle stage or higher by Day 7 (based on evaluator and self-assessments of legion stage) was considered "aborted" or "blocked". Any episode of oral herpes that reached a vesicle stage or higher by Day 7 was considered a treatment failure.
Time frame: 0 -7 days
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