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

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ClinicalTrials.gov Identifier: NCT01308424
Recruitment Status : Completed
First Posted : March 4, 2011
Results First Posted : August 13, 2013
Last Update Posted : August 13, 2013
Sponsor:
Collaborator:
Norwich Clinical Research Associates Ltd.
Information provided by (Responsible Party):
Beech Tree Labs, Inc.

Study Description
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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

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Arms and Interventions
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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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01308424


Locations
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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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Responsible Party: Beech Tree Labs, Inc.
ClinicalTrials.gov Identifier: NCT01308424    
Other Study ID Numbers: 2010-03-0112
First Posted: March 4, 2011    Key Record Dates
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:
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Virus Diseases
Herpesviridae Infections
Herpes Simplex
Stomatitis, Herpetic
DNA Virus Infections
Skin Diseases, Viral
 Skin Diseases, Infectious
Skin Diseases
Stomatitis
Mouth Diseases
Stomatognathic Diseases