Safety and Efficacy Study of a New Treatment for Recurrent Symptoms of Oral Herpes Virus Infection
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
1 other identifier
interventional
171
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2011
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 2, 2011
CompletedFirst Posted
Study publicly available on registry
March 4, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedResults Posted
Study results publicly available
August 13, 2013
CompletedAugust 13, 2013
August 1, 2013
1.8 years
March 2, 2011
May 22, 2013
August 12, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (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).
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.
7-14 days (depending on time of lesion outbreak - subjects had 7 days to experience a new emerging cold sore)
Study Arms (2)
BTL TML HSV
EXPERIMENTALMatching Placebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Immuno-suppressed or taking immunosuppressant medication
- Use of antiviral therapy directly prior and during the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Beech Tree Labs, Inc.lead
- Norwich Clinical Research Associates Ltd.collaborator
Study Sites (4)
University of Kentucky College of Dentistry/Center for Oral Health Research
Lexington, Kentucky, 40536, United States
School of Dental Medicine, University at Buffalo
Buffalo, New York, 14214, United States
Family Dentistry
Norwich, New York, 13815, United States
University of Pittsburgh School of Dental Medicine
Pittsburgh, Pennsylvania, 15261, United States
Related Publications (1)
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.
PMID: 35142535DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. John McMichael
- Organization
- Beech Tree Labs, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 2, 2011
First Posted
March 4, 2011
Study Start
January 1, 2011
Primary Completion
October 1, 2012
Study Completion
November 1, 2012
Last Updated
August 13, 2013
Results First Posted
August 13, 2013
Record last verified: 2013-08