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

Primary Purpose

Oral Herpes Simplex

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BTL TML HSV
Matching placebo
Sponsored by
Beech Tree Labs, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oral Herpes Simplex focused on measuring Herpes Labialis, Herpes Simplex, Herpes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Kentucky College of Dentistry/Center for Oral Health Research
  • School of Dental Medicine, University at Buffalo
  • Family Dentistry
  • University of Pittsburgh School of Dental Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

BTL TML HSV

Matching Placebo

Arm Description

Outcomes

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).
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.

Secondary Outcome Measures

Full Information

First Posted
March 2, 2011
Last Updated
August 12, 2013
Sponsor
Beech Tree Labs, Inc.
Collaborators
Norwich Clinical Research Associates Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01308424
Brief Title
Safety and Efficacy Study of a New Treatment for Recurrent Symptoms of Oral Herpes Virus Infection
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 Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beech Tree Labs, Inc.
Collaborators
Norwich Clinical Research Associates Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Herpes Simplex
Keywords
Herpes Labialis, Herpes Simplex, Herpes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
171 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BTL TML HSV
Arm Type
Experimental
Arm Title
Matching Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
BTL TML HSV
Intervention Description
Sublingual micro-dosing for 7 days
Intervention Type
Drug
Intervention Name(s)
Matching placebo
Intervention Description
sublingual dosing for 7 days
Primary Outcome Measure Information:
Title
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).
Description
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.
Time Frame
7-14 days (depending on time of lesion outbreak - subjects had 7 days to experience a new emerging cold sore)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University of Kentucky College of Dentistry/Center for Oral Health Research
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
School of Dental Medicine, University at Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14214
Country
United States
Facility Name
Family Dentistry
City
Norwich
State/Province
New York
ZIP/Postal Code
13815
Country
United States
Facility Name
University of Pittsburgh School of Dental Medicine
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15261
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35142535
Citation
Mamber SW, Hatch T, Miller CS, Murray JV, Strout C, McMichael J. Low-dose Oral Thimerosal for the Treatment of Oral Herpes: Clinical Trial Results and Improved Outcome After Post-hoc Analysis. J Evid Based Integr Med. 2022 Jan-Dec;27:2515690X221078004. doi: 10.1177/2515690X221078004.
Results Reference
derived

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

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