Double-blind, Vehicle-controlled Study of the Efficacy and Safety of SADBE in Subjects With Recurrent Herpes Labialis

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 2, Multi-site, Randomized, Double-blind, Vehicle-controlled Study of the Efficacy and Safety of Squaric Acid Dibutyl Ester (SADBE) in Subjects With Recurrent Herpes Labialis - Single Versus Two-dose Arm Application

Conditions
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Cold Sore, Herpes Labialis

Intervention / Treatment
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* Drug: SADBE
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria: People that have had treatment with anti viral therapy within 2 weeks before sensitization dose. Pregnant or lactating females. Current or recurrent non-herpetic 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 immunosuppressants at time of recruitment or within past 4 weeks, except for inhaled corticosteroids for asthma or topical steroids in sites other than face. History of malignancy (except patients with surgically cured basal cell or squamous cell skin cancers) History of organ transplantation HIV-positive status determined by history at screening or known history of any other immunosuppressive disease. Severe co-morbidities (diabetes mellitus requiring insulin, CHF (EF<50% at baseline will be exclusionary) MI, CVA or TIA within 3 months of screening visit, unstable angina pectoris, oxygen-dependent severe pulmonary disease History of exposure to squaric acid or squaric acid dibutyl ester. Known hypersensitivity to DMSO Any condition judged by the investigator to cause this clinical trial to be detrimental to the patient. 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. Previous or current participation in a clinical trial of SADBE to treat herpes labialis.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: One SADBE application<br>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. | Drug: SADBE<br>* Topical solution<br>* Other names: Squaric acid dibutyl ester;Other: Placebo<br>* Topical solution<br>* Other names: Vehicle-DMSO;|
| Active Comparator: Two SADBE applications<br>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. | Drug: SADBE<br>* Topical solution<br>* Other names: Squaric acid dibutyl ester;|
| Placebo Comparator: Placebo application (DMSO only-No SADBE)<br>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. | Other: Placebo<br>* Topical solution<br>* Other names: Vehicle-DMSO;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |