Oral Herpes SimplexPhase 1/2NCT01308424

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

A Phase 1/2 study testing BTL TML HSV in people with Oral Herpes Simplex, run by Beech Tree Labs, Inc. at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Oral Herpes Simplex
What is being tested?: BTL TML HSV
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 171 participants
Where: 4 sitesUnited States
Study dates: Jan 2011to Nov 2012
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

Who cannot join

Immuno-suppressed or taking immunosuppressant medication
Use of antiviral therapy directly prior and during the study

Trial locations and contacts

4 sites in 1 country.

United States4 sites

School of Dental Medicine, University at Buffalo
Buffalo, New York, 14214
University of Kentucky College of Dentistry/Center for Oral Health Research
Lexington, Kentucky, 40536
Family Dentistry
Norwich, New York, 13815
University of Pittsburgh School of Dental Medicine
Pittsburgh, Pennsylvania, 15261

Other trials in United States

About this study

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

The purpose of this study is to determine if a new treatment is effective for the treatment of recurrent symptomatic oral herpes virus infections.

Conditions: Oral Herpes Simplex
Being tested: BTL TML HSV, Matching placebo
Keywords: Herpes Labialis, Herpes Simplex, Herpes
Medical subject headings: Stomatitis, Herpetic, Herpes Labialis, Herpes Simplex

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BTL TML HSVDrug
Sublingual micro-dosing for 7 days
Matching placeboDrug
sublingual dosing for 7 days

Study groups in NCT01308424
Study group	Role	What they receive
BTL TML HSV	Experimental	Not described Receives: Drug: BTL TML HSV
Matching Placebo	Placebo comparator	Not described Receives: Drug: Matching placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 7-14 days (depending on time of lesion outbreak - subjects had 7 days to experience a new emerging cold sore)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2011Nov 2012

First posted4 Mar 2011 (estimated)
Study startJan 2011
Primary completionOct 2012
Study completionNov 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Oral Herpes SimplexStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 171 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01308424
Sponsor's protocol ID: 2010-03-0112
Status last verified: Aug 2013
First submitted: 2 Mar 2011
Last updated: 13 Aug 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 35142535

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Improving Prescribing Quality for Oral Mucosal Disorders Using a Pharmacist-Led Model
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All Oral Herpes Simplex trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01308424
Acronym / sponsor ID: 2010-03-0112
Conditions: Oral Herpes Simplex
Keywords: Herpes Labialis, Herpes Simplex, Herpes
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 171 participants (actual)
Lead sponsor: Beech Tree Labs, Inc.Industry (pharma, biotech, devices)
Collaborators: Norwich Clinical Research Associates Ltd.
Study start: Jan 2011
Primary completion: Oct 2012 (actual)
Study completion: Nov 2012 (actual)
First posted: 4 Mar 2011 (estimated)
Results: Posted 13 Aug 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to determine if a new treatment is effective for the treatment of recurrent symptomatic oral herpes virus infections.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
BTL TML HSV	Experimental	Drug: BTL TML HSV
Matching Placebo	Placebo comparator	Drug: Matching placebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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)

Key exclusion criteria (2 listed)

Immuno-suppressed or taking immunosuppressant medication
Use of antiviral therapy directly prior and during the study

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BTL TML HSVSublingual micro-dosing for 7 days	Drug	BTL TML HSV
Matching placebosublingual dosing for 7 days	Drug	Matching Placebo

Primary outcome

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.

Results and safety

Results posted to the registry on 13 Aug 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Baseline Run In	242	171
Matching Placebo	0	0
BTL TML HSV	0	0

Primary outcome: 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). Number. Unit: percentage of Participants

Measure	Matching Placebo n = 23	BTL TML HSV n = 9
Value	77.8	45.5

Population analysed: As randomized subjects waited until reoccurrence of cold sore lesions, 23/87 participants in the placebo treatment group and 9/84 in the BTL-TML-HSV group took study medication and were eligible for the primary outcome.

Adverse events

Time frame: Adverse Events were collected from the time of signing informed consent till the subjects completed the study (up to 28 days). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Baseline Run In	0 of 71 (0%)	0 of 71 (0%)	Not reported
Matching Placebo	2 of 87 (2.3%)	32 of 87 (36.8%)	Not reported
BTL TML HSV	0 of 84 (0%)	29 of 84 (34.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35142535Mamber 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.

Related trials for Oral Herpes Simplex

RecruitingObservational study
Viral Infections in Healthy and Immunocompromised Hosts
Anogenital Herpes, COVID-19
Recruiting
The Analgesic Efficacy and Safety of Venlafaxine for Prevention of Postherpetic Neuralgia in Patients With Acute Herpes Zoster
Herpes Zoster, Pain
Not yet recruiting
Improving Prescribing Quality for Oral Mucosal Disorders Using a Pharmacist-Led Model
Oral Lichen Planus, Recurrent Aphthous Stomatitis
Active, not recruitingPhase 4
Recombinant Herpes Zoster Vaccine in Patients With Autoimmune Rheumatic Diseases
Rheumatoid Arthritis, Spondylitis, Ankylosing
Recruiting
The Analgesic Efficacy and Safety of Mirogabalin in Patients With Herpes Zoster
Herpes Zoster, Mirogabalin

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing BTL TML HSV in people with Oral Herpes Simplex, run by Beech Tree Labs, Inc. at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01308424, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2013.