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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2% Squaric Acid Sensitization | Active Comparator | 2% Squaric Acid solution will be applied for sensitization to the inner arm. |
|
| Placebo Solution | Placebo Comparator | Patients in placebo group will be given dimethyl sulfoxide. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Squaric Acid solution | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexandra B Kimball, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 0.2% Squaric Acid | 0.2% Squaric Acid solution disolved in dimethyl sulfoxide will be applied Squaric Acid solution |
| FG001 | 0.5% Squaric Acid | 0.5% Squaric Acid solution disolved in dimethyl sulfoxide will be applied Squaric Acid solution |
| FG002 | Placebo Solution | Patients in placebo group will be given dimethyl sulfoxide. Placebo solution |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 0.2% Squaric Acid | 0.2% Squaric Acid solution disolved in dimethyl sulfoxide will be applied Squaric Acid solution |
| BG001 | 0.5% Squaric Acid | 0.5% Squaric Acid solution disolved in dimethyl sulfoxide will be applied Squaric Acid solution |
| 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 | 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 | 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%. | Posted | Number | percentage of particpants | 8 months |
|
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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 | 0.2% Squaric Acid | 0.2% Squaric Acid solution disolved in dimethyl sulfoxide will be applied Squaric Acid solution |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non Serious Itching, Redness, or Swelling | Skin and subcutaneous tissue disorders | Systematic Assessment | Subjects who reported itching, redness, or swelling and were recorded as a non-serious AE |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Maria Alora-Palli | Massachusetts General Hospital | 6177265066 | mpalli@mgh.harvard.edu |
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| ID | Term |
|---|---|
| D006560 | Herpes Labialis |
| ID | Term |
|---|---|
| D006561 | Herpes Simplex |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| C020637 | squaric acid dibutyl ester |
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| Placebo solution | Drug |
|
| BG002 | Placebo Solution | Patients in placebo group will be given dimethyl sulfoxide. Placebo solution |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Number of Outbreaks a year | Mean | Standard Deviation | frequency per year |
|
| Placebo Solution |
Patients in placebo group will be given dimethyl sulfoxide. Placebo solution |
|
|
| 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. | Not Posted | 8 months | Participants |
| 0 |
| 17 |
| 9 |
| 17 |
| EG001 | 0.5% Squaric Acid | 0.5% Squaric Acid solution disolved in dimethyl sulfoxide will be applied Squaric Acid solution | 0 | 18 | 6 | 18 |
| EG002 | Placebo Solution | Patients in placebo group will be given dimethyl sulfoxide. Placebo solution | 0 | 19 | 3 | 19 |
|
| Other Non Serious AE | Skin and subcutaneous tissue disorders | Systematic Assessment | Other AEs that were reported by subjects but were non-serious |
|
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| D007239 |
| Infections |
| D017193 | Skin Diseases, Viral |
| D008047 | Lip Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |