Herpes Labialis
Conditions
Brief summary
Subjects with a history of recurrent herpes labialis will be sensitized with either 2% SADBE or placebo. Following this, subjects sensitized with 2% SADBE will received.2% sqauric acid or.5% squaric acid on their cold sore within 72 hours of a recurrence. Subjects sensitized with placebo solution will receive placebo solution on their cold sore within 72 hours of a recurrence. Subjects will be followed for up to 6 mos after application of study medication.
Interventions
DRUGSquaric Acid solution
DRUGPlacebo solution
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age \>18 * With clinical diagnosis of herpes labialis. * who self report having six or more episodes of herpes labialis in the previous 12 months.
Exclusion criteria
* Pregnant or lactating females. * Current or recurrent infection or any underlying condition that may predispose to infection or anyone who has been admitted to the hospital due to bacteremia, pneumonia or any other serious infection. * Therapy with glucocorticoid or immunosuppressant at time of recruitment or within past 4 weeks, except for inhaled corticosteroids for asthma. * History of malignancy (except patients with surgically cured basal cell or squamous cell skin cancers who will be eligible) * History of organ transplantation * Negative HIV-positive status determined by history at screening or known history of any other immuno-suppressing disease. * Severe comorbidities (diabetes mellitus requiring insulin, CHF (EF\<50% at baseline will be exclusionary) of any severity, MI, CVA or TIA within 3 months of screening visit, unstable angina pectoris, oxygen-dependent severe pulmonary disease * Subject is currently enrolled in another investigational device or drug trial(s), or subject has received other investigational agent(s) within 28 days of baseline visit. * Subjects who have known hypersensitivity to Squaric acid or any of its components. * History of recent alcohol or substance abuse (\< 1 year) * Any condition judged by the investigator to cause this clinical trial to be detrimental to the patient. * History of psychiatric disease that would interfere with the patient's ability to comply with the study protocol * History of non-compliance with other therapies.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjects With at Least One Form of Contact With Study Staff With no Herpes Labialis Outbreaks Within 119 Days of Sensitization | 8 months | Percent of subjects with no reported herpes labialis outbreak within 119 days of sensitization over total number of subjects after one form of contact with study staff |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Adverse Events Reported | 8 months | To assess the safety and tolerability of squaric acid solution the number of adverse events in each treatment arm will be collected and compared. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 0.2% Squaric Acid 0.2% Squaric Acid solution disolved in dimethyl sulfoxide will be applied
Squaric Acid solution | 17 |
| 0.5% Squaric Acid 0.5% Squaric Acid solution disolved in dimethyl sulfoxide will be applied
Squaric Acid solution | 18 |
| Placebo Solution Patients in placebo group will be given dimethyl sulfoxide.
Placebo solution | 19 |
| Total | 54 |
Baseline characteristics
| Characteristic | 0.2% Squaric Acid | 0.5% Squaric Acid | Placebo Solution | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 18 Participants | 19 Participants | 52 Participants |
| Age, Continuous | 44.86 years STANDARD_DEVIATION 13.68 | 47.21 years STANDARD_DEVIATION 9.37 | 44.13 years STANDARD_DEVIATION 10.88 | 44.93 years STANDARD_DEVIATION 11.88 |
| Number of Outbreaks a year | 7.06 frequency per year STANDARD_DEVIATION 1.71 | 7.81 frequency per year STANDARD_DEVIATION 1.81 | 8.14 frequency per year STANDARD_DEVIATION 2.42 | 7.68 frequency per year STANDARD_DEVIATION 2.02 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 13 Participants | 17 Participants | 18 Participants | 48 Participants |
| Region of Enrollment United States | 17 participants | 18 participants | 19 participants | 54 participants |
| Sex: Female, Male Female | 14 Participants | 13 Participants | 13 Participants | 40 Participants |
| Sex: Female, Male Male | 3 Participants | 5 Participants | 6 Participants | 14 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 | 9 / 17 | 6 / 18 | 3 / 19 |
| serious Total, serious adverse events | 0 / 17 | 0 / 18 | 0 / 19 |
Outcome results
Primary
Subjects With at Least One Form of Contact With Study Staff With no Herpes Labialis Outbreaks Within 119 Days of Sensitization
Percent of subjects with no reported herpes labialis outbreak within 119 days of sensitization over total number of subjects after one form of contact with study staff
Time frame: 8 months
Population: Because most patients who received 2% SADBE for sensitization did not experience another herpes outbreak and thus did not receive a subsequent treatment dose, we grouped both squaric acid treatment arms together for analysis since both groups had received the same sensitization dose of 2%.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 2% Squaric Acid Sensitization | Subjects With at Least One Form of Contact With Study Staff With no Herpes Labialis Outbreaks Within 119 Days of Sensitization | 62.96 percentage of particpants |
| Placebo Solution | Subjects With at Least One Form of Contact With Study Staff With no Herpes Labialis Outbreaks Within 119 Days of Sensitization | 20 percentage of particpants |
Secondary
Number of Adverse Events Reported
To assess the safety and tolerability of squaric acid solution the number of adverse events in each treatment arm will be collected and compared.
Time frame: 8 months