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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Oral Herpes Simplex	Drug: BTL TML HSV; Drug: Matching placebo	Phase 1; Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	171 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official 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
Study Start Date :	January 2011
Actual Primary Completion Date :	October 2012
Actual Study Completion Date :	November 2012

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: BTL TML HSV	Drug: BTL TML HSV; Sublingual micro-dosing for 7 days
Placebo Comparator: Matching Placebo	Drug: Matching placebo; sublingual dosing for 7 days

Outcome Measures

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Primary Outcome Measures :

1. 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.

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Kentucky
University of Kentucky College of Dentistry/Center for Oral Health Research
Lexington, Kentucky, United States, 40536
United States, New York
School of Dental Medicine, University at Buffalo
Buffalo, New York, United States, 14214
Family Dentistry
Norwich, New York, United States, 13815
United States, Pennsylvania
University of Pittsburgh School of Dental Medicine
Pittsburgh, Pennsylvania, United States, 15261

Sponsors and Collaborators

Beech Tree Labs, Inc.

Norwich Clinical Research Associates Ltd.

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Beech Tree Labs, Inc.
ClinicalTrials.gov Identifier:	NCT01308424 History of Changes
Other Study ID Numbers:	2010-03-0112
First Posted:	March 4, 2011
Results First Posted:	August 13, 2013
Last Update Posted:	August 13, 2013
Last Verified:	August 2013

Keywords provided by Beech Tree Labs, Inc.:

Herpes Labialis; Herpes Simplex; Herpes

Additional relevant MeSH terms:

Virus Diseases; Herpes Simplex; Herpesviridae Infections; Stomatitis, Herpetic; DNA Virus Infections; Skin Diseases, Viral	Skin Diseases, Infectious; Skin Diseases; Stomatitis; Mouth Diseases; Stomatognathic Diseases