Oral Herpes SimplexPhase 2NCT01902303
Evaluation of Cold Sore Treatments on Ultra Violet (UV) Induced Cold Sores
A Phase 2 study testing BTL-TML-HSV in people with Oral Herpes Simplex, run by Beech Tree Labs, Inc. at 3 sites in United States.
Trial summary
The purpose of this study is to determine if a new drug treatment is effective to block the development of a cold sore lesion following Ultra Violet (UV) exposure. 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
- 303 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2013to Feb 2015
- Phase
- Phase 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
- UV exposure is known to cause a cold sore outbreak
Who cannot join
- History of abnormal reactions to sunlight
- Used antiviral therapy directly prior to entering study
- Any other condition which in the opinion of the Investigator may affect the results or place the subject at undue risk.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Hill Top Research
Cincinnati, Ohio, 45242
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464
Hill Top Research
St. Petersburg, Florida, 33714
About this study
Official title: Evaluation of Cold Sore Treatments on UV Induced Cold Sores
The purpose of this study is to determine if a new drug treatment is effective to block the development of a cold sore lesion following Ultra Violet (UV) exposure.
Read the detailed description
This was a multi-center, randomized, evaluator and subject-blind, placebo controlled study design
The objective of this study was to evaluate the ability of the test articles to block the development of a cold sore lesion from progressing beyond the prodromal stage following a UV-induced process.
The primary efficacy endpoint of this study was to determine if a recurrent oral herpes episode initiated with prodromal symptoms was aborted before progressing to a lesion (vesicle) via assessing lesion stages by a trained evaluator.
The secondary efficacy endpoints included: a) subject self-assessments and b) test article weights and diaries to track treatment compliance.
- Conditions
- Oral Herpes Simplex
- Being tested
- Matching Placebo, BTL-TML-HSV
- Keywords
- Herpes Labialis, Herpes Simplex, Herpes, Ultra Violet (UV) Induced
- 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.
Matching PlaceboDrug
Sublingual micro dosing of placebo for 7 days
BTL-TML-HSVDrug
Sublingual micro dosing of BTL-TML-HSV for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Matching Placebo | Placebo comparator | Matching Placebo Receives: Drug: Matching Placebo |
| BTL-TML-HSV | Experimental | Experimental Product Receives: Drug: BTL-TML-HSV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants for Whom a Recurrent Oral Herpes Episode Initiated With Prodromal Symptoms Were Aborted Before Progressing to a Lesion as Assessed by a Trained Evaluator
The primary efficacy endpoint of this study is to determine if a recurrent oral herpes episode initiated with prodromal symptoms is aborted before progressing to a lesion (vesicle stage) via assessing lesion stages by the trained evaluator. Any episode of oral herpes that did not reach a vesicle stage or higher by Day 7 (based on evaluator and self-assessments of legion stage) was considered "aborted" or "blocked". Any episode of oral herpes that reached a vesicle stage or higher by Day 7 was considered a treatment failure.
Measured: Day 0- Day 7
Secondary outcomes (1)
Number of Participants for Whom a Recurrent Oral Herpes Episode Initiated With Prodromal Symptoms Were Aborted Before Progressing to a Lesion as Assessed by the Participant
The secondary efficacy endpoint of this study is to determine if a recurrent oral herpes episode initiated with prodromal symptoms is aborted before progressing to a lesion (vesicle stage) via assessing lesion stages by the participant. Any episode of oral herpes that did not reach a vesicle stage or higher by Day 7 (based on evaluator and self-assessments of legion stage) was considered "aborted" or "blocked". Any episode of oral herpes that reached a vesicle stage or higher by Day 7 was considered a treatment failure.
Measured: 0 -7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionSep 2014
- Study completionFeb 2015
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beech Tree Labs, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Norwich Clinical Research Associates Ltd., Hill Top Research
- Responsible party
- Sponsor
- Investigators
- John McMichael, PhD, Study director, President, Beech Tree Labs, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01902303
- Sponsor's protocol ID
- BTL - 2013-06-0161
- Other IDs
- HTR - 13-131178
- Status last verified
- Mar 2016
- First submitted
- 15 Jul 2013
- Last updated
- 28 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cold Sore Treatments on UV Induced Cold Sores
- ClinicalTrials.gov ID
- NCT01902303
- Acronym / sponsor ID
- BTL - 2013-06-0161
- Conditions
- Oral Herpes Simplex
- Keywords
- Herpes Labialis, Herpes Simplex, Herpes, Ultra Violet (UV) Induced
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- Beech Tree Labs, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Norwich Clinical Research Associates Ltd., Hill Top Research
- Study start
- Jul 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 18 Jul 2013 (estimated)
- Results
- Posted 14 Mar 2016
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 drug treatment is effective to block the development of a cold sore lesion following Ultra Violet (UV) exposure.
Detailed description
This was a multi-center, randomized, evaluator and subject-blind, placebo controlled study design
The objective of this study was to evaluate the ability of the test articles to block the development of a cold sore lesion from progressing beyond the prodromal stage following a UV-induced process.
The primary efficacy endpoint of this study was to determine if a recurrent oral herpes episode initiated with prodromal symptoms was aborted before progressing to a lesion (vesicle) via assessing lesion stages by a trained evaluator.
The secondary efficacy endpoints included: a) subject self-assessments and b) test article weights and diaries to track treatment compliance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Matching Placebo | Placebo comparator | Drug: Matching PlaceboMatching Placebo |
| BTL-TML-HSV | Experimental | Drug: BTL-TML-HSVExperimental Product |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical history of recurrent cold sores averaging 2 or more episodes per year
- UV exposure is known to cause a cold sore outbreak
Key exclusion criteria (3 listed)
- History of abnormal reactions to sunlight
- Used antiviral therapy directly prior to entering study
- Any other condition which in the opinion of the Investigator may affect the results or place the subject at undue risk.
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 |
|---|---|---|
| Matching PlaceboSublingual micro dosing of placebo for 7 days | Drug | Matching Placebo |
| BTL-TML-HSVSublingual micro dosing of BTL-TML-HSV for 7 days | Drug | BTL-TML-HSV |
Primary outcome
Number of Participants for Whom a Recurrent Oral Herpes Episode Initiated With Prodromal Symptoms Were Aborted Before Progressing to a Lesion as Assessed by a Trained Evaluator
Time frame: Day 0- Day 7
The primary efficacy endpoint of this study is to determine if a recurrent oral herpes episode initiated with prodromal symptoms is aborted before progressing to a lesion (vesicle stage) via assessing lesion stages by the trained evaluator. Any episode of oral herpes that did not reach a vesicle stage or higher by Day 7 (based on evaluator and self-assessments of legion stage) was considered "aborted" or "blocked". Any episode of oral herpes that reached a vesicle stage or higher by Day 7 was considered a treatment failure.
1 secondary outcome
Number of Participants for Whom a Recurrent Oral Herpes Episode Initiated With Prodromal Symptoms Were Aborted Before Progressing to a Lesion as Assessed by the Participant
Time frame: 0 -7 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2016.
- 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.
- Individual participant dataSharing planned: No
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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.
John McMichael, PhD study director
President, Beech Tree Labs, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BTL-TML-HSV in people with Oral Herpes Simplex, run by Beech Tree Labs, Inc. at 3 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 2 inclusion and 3 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 28 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 phase mean?
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 14 Mar 2016). 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?
Number of Participants for Whom a Recurrent Oral Herpes Episode Initiated With Prodromal Symptoms Were Aborted Before Progressing to a Lesion as Assessed by a Trained Evaluator (time frame: Day 0- Day 7). 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 NCT01902303, 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 28 Apr 2016.