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

This study has been completed.
Sponsor:
Collaborator:
Norwich Clinical Research Associates Ltd.
Information provided by (Responsible Party):
Beech Tree Labs, Inc.
ClinicalTrials.gov Identifier:
NCT01308424
First received: March 2, 2011
Last updated: August 12, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Oral Herpes Simplex
Drug: BTL TML HSV
Drug: Matching placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Beech Tree Labs, Inc.:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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.


Enrollment: 171
Study Start Date: January 2011
Study Completion Date: November 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01308424

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

No publications provided

Responsible Party: Beech Tree Labs, Inc.
ClinicalTrials.gov Identifier: NCT01308424     History of Changes
Other Study ID Numbers: 2010-03-0112
Study First Received: March 2, 2011
Results First Received: May 22, 2013
Last Updated: August 12, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 01, 2014