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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

303 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2015-02-28

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.

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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.

Conditions

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Oral Herpes Simplex

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Matching Placebo

Group Type PLACEBO_COMPARATOR

Matching Placebo

Intervention Type DRUG

Sublingual micro dosing of placebo for 7 days

BTL-TML-HSV

Experimental Product

Group Type EXPERIMENTAL

BTL-TML-HSV

Intervention Type DRUG

Sublingual micro dosing of BTL-TML-HSV for 7 days

Interventions

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Matching Placebo

Sublingual micro dosing of placebo for 7 days

Intervention Type DRUG

BTL-TML-HSV

Sublingual micro dosing of BTL-TML-HSV for 7 days

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No