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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| One SADBE application | Active Comparator | 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. |
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| Two SADBE applications | Active Comparator | 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. |
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| Placebo application (DMSO only-No SADBE) | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SADBE | Drug | Topical solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 43 - 121 days after the first dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From day 43 after the first dose up to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hugh McTavish, PhD, JD | Squarex, LLC | Study Director |
| Thomas D Horn, MD | Squarex, LLC | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Medicine Outpatient Center | Redwood City | California | 94063 | United States | ||
| International Research Partners, LLC |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 16, 2017 |
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| Placebo | Other | Topical solution |
|
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| Doral |
| Florida |
| 33166 |
| United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Quality Clinical Research, Inc | Omaha | Nebraska | 68114 | United States |
| Advantage Clinical Trials | The Bronx | New York | 10468 | United States |
| 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 |
| FG002 | 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 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| HSV-1-neg / HSV-2 neg | Count of Participants | Participants |
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| HSV-1-neg / HSV-2 pos | Count of Participants | Participants |
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| HSV-1-pos / HSV-2 neg | Count of Participants | Participants |
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| HSV-1-pos / HSV-2 pos | Count of Participants | Participants |
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| Median self-reported prior outbreaks over 12 months | Count of Participants | Participants |
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| 4 or 5 prior outbreaks | Count of Participants | Participants |
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| 6 or more prior outbreaks | Count of Participants | Participants |
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| 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 | 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 | Posted | Median | Full Range | days | 43 - 121 days after the first dose |
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| ||||||||||||||||||||||||||||||||
| 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 | Posted | Mean | Standard Deviation | outbreaks per participant | From day 43 after the first dose up to 12 months |
|
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1 Year
Subjects receiving One or Two doses of SADBE were combined for Adverse Event Reporting because they did not experience adverse events at different incidence rates.
The terms mild, moderate, and severe were undefined except "severe" was defined as requiring topical corticosteroid treatment and none of these events correspond to a serious adverse event or to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 terms for skin and subcutaneous tissue disorders.
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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 | Placebo Application (DMSO Only-No SADBE) | Placebo | 0 | 47 | 0 | 47 | 17 | 47 |
| EG001 | Two SADBE Applications | 2-dose | 0 | 46 | 0 | 46 | 19 | 46 |
| EG002 | One SADBE Application | 1-dose | 0 | 46 | 0 | 46 | 18 | 46 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dead skin at application site | Skin and subcutaneous tissue disorders | CTCAE | Non-systematic Assessment |
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| Dermatitis at application site | Skin and subcutaneous tissue disorders | CTCAE | Non-systematic Assessment |
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| Erythema, stain, or rash at application site | Skin and subcutaneous tissue disorders | CTCAE | Non-systematic Assessment |
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| Erythema distal from application site | Skin and subcutaneous tissue disorders | CTCAE | Non-systematic Assessment |
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| Flushed burning sensation on face | Skin and subcutaneous tissue disorders | CTCAE | Non-systematic Assessment |
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| Herpes lesion on genitals, anus, or spine | Skin and subcutaneous tissue disorders | CTCAE | Non-systematic Assessment |
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| Irritation, itching at application site | Skin and subcutaneous tissue disorders | CTCAE | Non-systematic Assessment |
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| Irritation, itching distal from application site | Skin and subcutaneous tissue disorders | CTCAE | Non-systematic Assessment |
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| Lightheadedness | Skin and subcutaneous tissue disorders | CTCAE | Non-systematic Assessment |
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| Pimple | Skin and subcutaneous tissue disorders | CTCAE | Non-systematic Assessment |
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| Purpura at application site | Skin and subcutaneous tissue disorders | CTCAE | Non-systematic Assessment |
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| Papule on lip | Skin and subcutaneous tissue disorders | CTCAE | Non-systematic Assessment |
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| Dermatitis from adhesive | Skin and subcutaneous tissue disorders | CTCAE | Non-systematic Assessment |
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| Burning at application site. | Skin and subcutaneous tissue disorders | CTCAE | Non-systematic Assessment |
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| Tingling, stinging at application site | Skin and subcutaneous tissue disorders | CTCAE | Non-systematic Assessment |
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| Tingling distal from application site | Skin and subcutaneous tissue disorders | CTCAE | Non-systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | CTCAE | Non-systematic Assessment |
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| Boil at application site | Skin and subcutaneous tissue disorders | CTCAE | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hugh McTavish | Squarex LLC | 6512078270 | hmctavish@squarex-pharma.com |
| May 19, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D006560 | Herpes Labialis |
| ID | Term |
|---|---|
| D006561 | Herpes Simplex |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| 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 |
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| ID | Term |
|---|---|
| C020637 | squaric acid dibutyl ester |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Black |
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| Hispanic |
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| White |
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| Unasnswered |
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