Oral Herpes Simplex
Conditions
Keywords
Herpes Labialis, Herpes Simplex, Herpes, Ultra Violet (UV) Induced
Brief 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.
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.
Interventions
DRUGMatching Placebo
Sublingual micro dosing of placebo for 7 days
DRUGBTL-TML-HSV
Sublingual micro dosing of BTL-TML-HSV for 7 days
Sponsors
Norwich Clinical Research Associates Ltd.
Hill Top Research
Beech Tree Labs, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical history of recurrent cold sores averaging 2 or more episodes per year * UV exposure is known to cause a cold sore outbreak
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 0 -7 days | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Matching Placebo Placebo Safety Population - All subjects enrolled and received placebo test article | 77 |
| BTL-TML-HSV Active Treatment BTL-TML Safety Population - All subjects enrolled and received active test article | 81 |
| Total | 158 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Did not develop a cold sore | 21 | 19 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Protocol Violation | 2 | 2 |
| Overall Study | subject lost investigational product | 0 | 1 |
Baseline characteristics
| Characteristic | Matching Placebo | BTL-TML-HSV Active Treatment | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 8 Participants | 13 Participants |
| Age, Categorical Between 18 and 65 years | 72 Participants | 73 Participants | 145 Participants |
| Sex: Female, Male Female | 58 Participants | 57 Participants | 115 Participants |
| Sex: Female, Male Male | 19 Participants | 24 Participants | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 7 / 56 | 6 / 62 |
| serious Total, serious adverse events | 0 / 222 | 0 / 81 |
Outcome results
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.
Time frame: Day 0- Day 7
Population: Participants that did not experience prodrome stage as assessed by the evaluator or met major protocol violations were not included in the PP analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Matching Placebo | 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 | 6 participants who had aborted lesions |
| BTL-TML-HSV Active Treatment | 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 | 11 participants who had aborted lesions |
p-value: >0.5Chi-squared
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.
Time frame: 0 -7 days
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Matching Placebo | 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 | 6 participants with aborted lesions |
| BTL-TML-HSV Active Treatment | 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 | 8 participants with aborted lesions |
p-value: 0.3835Chi-squared