Text Size

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: March 5, 2013
Last verified: March 2013
History of Changes
  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:

MedlinePlus related topics: Herpes Simplex
U.S. FDA Resources

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

Primary Outcome Measures:
  • Symptomatic lesions of a oral herpes simplex outbreak [ Time Frame: Daily for 7 days ] [ Designated as safety issue: No ]
    Lesion classification based on diary card and investigator assessment


Secondary Outcome Measures:
  • Number of participants with adverse events [ Time Frame: The course of the study ] [ Designated as safety issue: Yes ]
    Review of adverse experiences, laboratory values to access patient safety


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 ser0positive (by blood test)

Exclusion Criteria:

  • Immuno-suppressed or taking immunosuppressant medication
  • Use of antiviral therapy directly prior and during the study
  Contacts and Locations
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
Last Updated: March 5, 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:
Herpes Simplex
Herpesviridae Infections
Stomatitis, Herpetic
Virus Diseases
DNA Virus Infections
Skin Diseases, Viral
 Skin Diseases, Infectious
Skin Diseases
Stomatitis
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on May 19, 2013