Oral Herpes Simplex
Conditions
Keywords
Herpes Labialis, Herpes Simplex, Herpes
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.
Interventions
DRUGBTL TML HSV
Sublingual micro-dosing for 7 days
DRUGMatching placebo
sublingual dosing for 7 days
Sponsors
Norwich Clinical Research Associates Ltd.
Beech Tree Labs, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
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 * Experiences prodromal symptoms (tingling, burning, itching) of cold sores * Herpes Simplex Virus seropositive (by blood test)
Exclusion criteria
* Immuno-suppressed or taking immunosuppressant medication * Use of antiviral therapy directly prior and during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from four dental clinics in the USA during the study period of 1/26/11 - 9/14/2012
Pre-assignment details
Participants entered a baseline run in period to assess eligibility before randomization and dental procedure.
Participants by arm
| Arm | Count |
|---|---|
| Matching Placebo Matching placebo : sublingual dosing for 7 days | 87 |
| BTL TML HSV BTL TML HSV : Sublingual micro-dosing for 7 days | 84 |
| Total | 171 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Baseline Eligibility | Screen Failures | 71 | 0 | 0 |
| Randomization | Adverse Event | 0 | 1 | 1 |
| Randomization | Lost to Follow-up | 0 | 1 | 0 |
| Randomization | Physician Decision | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | Matching Placebo | BTL TML HSV | Total |
|---|---|---|---|
| Age Continuous | 41.6 years | 45.2 years | 43.3 years |
| Region of Enrollment United States | 87 participants | 84 participants | 171 participants |
| Sex: Female, Male Female | 55 Participants | 61 Participants | 116 Participants |
| Sex: Female, Male Male | 32 Participants | 23 Participants | 55 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 71 | 32 / 87 | 29 / 84 |
| serious Total, serious adverse events | 0 / 71 | 2 / 87 | 0 / 84 |
Outcome results
Primary
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.
Time frame: 7-14 days (depending on time of lesion outbreak - subjects had 7 days to experience a new emerging cold sore)
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Matching Placebo | 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). | 77.8 percentage of Participants |
| BTL TML HSV | 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). | 45.5 percentage of Participants |