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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of Cold Sore Treatments on UV Induced Cold Sores

Conditions
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Oral Herpes Simplex

Intervention / Treatment
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* Drug: Matching Placebo
* Drug: BTL-TML-HSV


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Matching Placebo<br>Matching Placebo | Drug: Matching Placebo<br>* Sublingual micro dosing of placebo for 7 days<br>|
| Experimental: BTL-TML-HSV<br>Experimental Product | Drug: BTL-TML-HSV<br>* Sublingual micro dosing of BTL-TML-HSV for 7 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 0- Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 0 -7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Herpes Labialis, Herpes Simplex, Herpes, Ultra Violet (UV) Induced