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| ID | Type | Description | Link |
|---|---|---|---|
| HTR - 13-131178 | Other Identifier | Hill Top Research |
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| Name | Class |
|---|---|
| Norwich Clinical Research Associates Ltd. | OTHER |
| Hill Top Research | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Matching Placebo | Placebo Comparator | Matching Placebo |
|
| BTL-TML-HSV | Experimental | Experimental Product |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Matching Placebo | Drug | Sublingual micro dosing of placebo for 7 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 0- Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John McMichael, PhD | President, Beech Tree Labs, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hill Top Research | St. Petersburg | Florida | 33714 | United States | ||
| Hill Top Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35142535 | Derived | 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. |
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Subjects who did not meet inclusion/exclusion or withdrew consent prior to enrollment were not enrolled in the study. Eligible subjects underwent minimum erythema dose (MED) UVr determination and if MED criteria was met were randomized. Those enrolled who did not develop prodrome following the UVr induced process were not treated.
Recruitment occurred from 29Jul2013 through 09Sep2014. Subjects were recruited through three research clinics located in the US who had been trained in UVr application used to trigger recurrent oral Herpes Simplex Labialis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Matching Placebo | Matching Placebo Treatment regimens will be as follows (upon the first signs/symptoms of prodrome (tingling, itching, burning):
|
| FG001 | BTL-TML-HSV | Experimental Product BTL-TML-HSV: Sublingual micro dosing of BTL-TML-HSV for 7 days Treatment regimens will be as follows (upon the first signs/symptoms of prodrome (tingling, itching, burning):
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| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Demographics based on number of subjects who were randomization and subsequently assigned investigational product
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| ID | Title | Description |
|---|---|---|
| BG000 | Matching Placebo | Placebo Safety Population - All subjects enrolled and received placebo test article |
| BG001 | BTL-TML-HSV Active Treatment | BTL-TML Safety Population - All subjects enrolled and received active test article |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Participants that did not experience prodrome stage as assessed by the evaluator or met major protocol violations were not included in the PP analysis. | Posted | Number | participants who had aborted lesions | Day 0- Day 7 |
|
AEs were collected from the time of informed consent until end of follow up period which was up to 14 days after start of treatment.
Serious AE were collected for all patients. AEs noted over 5% were only for those patients that took study medication.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Matching Placebo | Placebo Safety Population - All subjects that enrolled and were allocated to placebo test article except for SAEs and that includes all subjects that signed informed consent. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood pressure diastolic increased | Investigations | MedDRA (16) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. John McMichael | Beech Tree Labs, Inc. | 518-872-1144 |
| ID | Term |
|---|---|
| D013283 | Stomatitis, Herpetic |
| D006560 | Herpes Labialis |
| D006561 | Herpes Simplex |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| BTL-TML-HSV |
| Drug |
Sublingual micro dosing of BTL-TML-HSV for 7 days |
|
| 0 -7 days |
| Cincinnati |
| Ohio |
| 45242 |
| United States |
| Coastal Carolina Research Center | Mt. Pleasant | South Carolina | 29464 | United States |
| Protocol Violation |
|
| subject lost investigational product |
|
| Did not develop a cold sore |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Placebo Efficacy Population - All subjects enrolled and received placebo test article and met Per protocol definition |
| OG001 | BTL-TML-HSV Active Treatment | BTL-TML Efficacy Population - All subjects enrolled and received active test article and met Per Protocol definition |
|
|
|
| Secondary | 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. | 158 subjects randomized to treatment. 118 subjects used allocated assigned treatment (62 test article and 56 placebo). 7 subjects failed to complete and 111 completed study. For this secondary analysis (self assessments) 53 subjects noted prodrome occurring on Day 0. | Posted | Number | participants with aborted lesions | 0 -7 days |
|
|
|
|
| 0 |
| 222 |
| 7 |
| 56 |
| EG001 | BTL-TML-HSV Active Treatment | BTL-TML Safety Population - All subjects enrolled and allocated to active test article except for SAEs which includes all subjects that signed informed consent. | 0 | 81 | 6 | 62 |
| Heart rate increased | Investigations | MedDRA (16) | Systematic Assessment |
|
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| D013280 |
| Stomatitis |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D017193 | Skin Diseases, Viral |
| D008047 | Lip Diseases |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |