Cold Sore, Herpes Labialis
Conditions
Brief summary
This study evaluates the safety and efficacy of SADBE in the prevention of recurrent herpes labialis in adults. Two-thirds of the participants will receive a SADBE solution, while the other third will receive only the vehicle as a placebo control. The solutions will be administered topically to the patient's arms. The study will compare a single-arm application versus a two-arm application versus two placebo doses on the arm.
Interventions
DRUGSADBE
Topical solution
OTHERPlacebo
Topical solution
Sponsors
Squarex, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 * Clinical diagnosis of herpes labialis, which may be made at the screening visit based on the patient's self-reported history of symptoms. An active herpes labialis outbreak at the time of entry into the clinical trial will neither be required nor will be an
Exclusion criteria
. * Self report having four or more episodes of herpes labialis in the past 12 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Days to Next Herpes Labialis (Cold Sore) Episode From 43 Days After the First Dose up to 121 Days After the First Dose | 43 - 121 days after the first dose | The number of days until a patient reports his or her first new herpes labialis episode from 43 - 121 days following the first dose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Outbreaks Beginning 43 Days After the First Dose up to 12 Months | From day 43 after the first dose up to 12 months | The number of new herpes labialis episodes per subject during the 12-month follow up period following the first drug dose, beginning day 43 after the first dose |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| One SADBE Application Patient will receive a topical 2% SADBE sensitization dose applied to the patient's upper arm. Three weeks after topical sensitization dose patient will receive topical placebo applied to the patient's upper arm.
SADBE: Topical solution
Placebo: Topical solution | 46 |
| Two SADBE Applications Patient will receive a topical 2% SADBE sensitization dose applied to the patient's upper arm. A 0.5% SADBE intensification dose will be applied to the patient's upper arm 3 weeks after sensitization dose.
SADBE: Topical solution | 46 |
| Placebo Application (DMSO Only-No SADBE) Patient will receive a topical placebo (vehicle-DMSO) dose applied to the patient's upper arm. A topical placebo (vehicle-DMSO) follow up dose will be applied to the patient's upper arm 3 weeks after the first placebo dose dose.
Placebo: Topical solution | 47 |
| Total | 139 |
Baseline characteristics
| Characteristic | Total | One SADBE Application | Two SADBE Applications | Placebo Application (DMSO Only-No SADBE) |
|---|---|---|---|---|
| 4 or 5 prior outbreaks | 55 Participants | 19 Participants | 15 Participants | 21 Participants |
| 6 or more prior outbreaks | 83 Participants | 27 Participants | 31 Participants | 25 Participants |
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 139 Participants | 46 Participants | 46 Participants | 47 Participants |
| Age, Continuous | 47.1 years | 47.8 years | 44.2 years | 50.1 years |
| HSV-1-neg / HSV-2 neg | 6 Participants | 1 Participants | 2 Participants | 3 Participants |
| HSV-1-neg / HSV-2 pos | 9 Participants | 1 Participants | 3 Participants | 5 Participants |
| HSV-1-pos / HSV-2 neg | 73 Participants | 30 Participants | 19 Participants | 24 Participants |
| HSV-1-pos / HSV-2 pos | 49 Participants | 14 Participants | 22 Participants | 13 Participants |
| Median self-reported prior outbreaks over 12 months | 18 Participants | 6 Participants | 6 Participants | 6 Participants |
| Race/Ethnicity, Customized Asian | 4 Participants | 1 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized Black | 26 Participants | 11 Participants | 7 Participants | 8 Participants |
| Race/Ethnicity, Customized Hispanic | 48 Participants | 13 Participants | 18 Participants | 17 Participants |
| Race/Ethnicity, Customized Unasnswered | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 60 Participants | 21 Participants | 18 Participants | 21 Participants |
| Region of Enrollment United States | 139 participants | 46 participants | 46 participants | 47 participants |
| Sex: Female, Male Female | 85 Participants | 31 Participants | 28 Participants | 26 Participants |
| Sex: Female, Male Male | 54 Participants | 15 Participants | 18 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 47 | 0 / 46 | 0 / 46 |
| other Total, other adverse events | 17 / 47 | 19 / 46 | 18 / 46 |
| serious Total, serious adverse events | 0 / 47 | 0 / 46 | 0 / 46 |
Outcome results
Primary
Days to Next Herpes Labialis (Cold Sore) Episode From 43 Days After the First Dose up to 121 Days After the First Dose
The number of days until a patient reports his or her first new herpes labialis episode from 43 - 121 days following the first dose
Time frame: 43 - 121 days after the first dose
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo Application (DMSO Only-No SADBE) | Days to Next Herpes Labialis (Cold Sore) Episode From 43 Days After the First Dose up to 121 Days After the First Dose | 128 days |
| Two SADBE Applications | Days to Next Herpes Labialis (Cold Sore) Episode From 43 Days After the First Dose up to 121 Days After the First Dose | 163 days |
| One SADBE Application | Days to Next Herpes Labialis (Cold Sore) Episode From 43 Days After the First Dose up to 121 Days After the First Dose | 174 days |
Secondary
Number of Outbreaks Beginning 43 Days After the First Dose up to 12 Months
The number of new herpes labialis episodes per subject during the 12-month follow up period following the first drug dose, beginning day 43 after the first dose
Time frame: From day 43 after the first dose up to 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Application (DMSO Only-No SADBE) | Number of Outbreaks Beginning 43 Days After the First Dose up to 12 Months | 0.610 outbreaks per participant | Standard Deviation 0.802 |
| Two SADBE Applications | Number of Outbreaks Beginning 43 Days After the First Dose up to 12 Months | 0.500 outbreaks per participant | Standard Deviation 0.849 |
| One SADBE Application | Number of Outbreaks Beginning 43 Days After the First Dose up to 12 Months | 0.231 outbreaks per participant | Standard Deviation 0.427 |