Safety and Efficacy Study of a New Treatment for Recurrent Symptoms of Oral Herpes Virus Infection

The purpose of this study is to determine if a new treatment is effective for the treatment of recurrent symptomatic oral herpes virus infections.

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Key information

Conditions

Oral Herpes Simplex DNA Virus Infections Herpes Labialis Herpes Simplex Herpesviridae Infections Infections Lip Diseases Mouth Diseases Skin Diseases Skin Diseases, Infectious Skin Diseases, Viral Skin and Connective Tissue Diseases Stomatitis Stomatitis, Herpetic Stomatognathic Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Kentucky College of Dentistry/Center for Oral Health Research, Lexington, Kentucky, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Clinical history of recurrent cold sores averaging 2 or more episodes per year
Experiences prodromal symptoms (tingling, burning, itching) of cold sores
Herpes Simplex Virus seropositive (by blood test)

Exclusion criteria

Immuno-suppressed or taking immunosuppressant medication
Use of antiviral therapy directly prior and during the study

Treatment and study plan

BTL TML HSV

Drug

Sublingual micro-dosing for 7 days

Matching Placebo

Drug

sublingual dosing for 7 days

Primary outcomes

Proportion of Subjects Who Experience a New Cold Sore Outbreak That Proceeds to the Lesion Stage. Of Those Subjects That Take Study Medication (Experience a New Emerging Cold Sore) Those That Proceed to Lesion Stage (Cold Sore Stage - 3 Vesicle or Above).

Time frame: 7-14 days (depending on time of lesion outbreak - subjects had 7 days to experience a new emerging cold sore)

Subjects start a daily diary based on start of symptoms of a new emerging cold sore and start taking study medication. Subjects note the start time of study medication along with cold sore stage(s)for at least 7 days and up to 14 days. Subjects take study medication for 7 days. Cold Sore stages are 0=Dormant, 1=Prodrome, 2=Inflammation, 3=Vesicle, 4=Ulcer, 5=Crust, 6=Healed. If subjects do not experience a new cold sore outbreak within 7 days, they do not take study medication and are completed with the study.

Sponsors and collaborators

Lead sponsor

Beech Tree Labs, Inc.

Industry

Collaborators

Norwich Clinical Research Associates Ltd.

Registry information

Official study title

A Randomized, Double-blind, Parallel, Placebo-controlled Study for the Assessment of the Safety and Efficacy of BTL-TML-HSV for the Treatment of Recurrent Symptomatic Oral Herpes Virus Infection

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Mar 4, 2011
Registry last updated: Aug 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed