Safety and Efficacy of Squaric Acid Dibutyl Ester for the Treatment of Herpes Labialis

Study Overview
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Brief Summary
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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.

Official Title
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A Clinical Trial to Test the Safety and Efficacy of Squaric Acid Dibutyl Ester for the Treatment of Herpes Labialis

Conditions
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Herpes Labialis

Intervention / Treatment
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* Drug: Squaric Acid solution
* Drug: Placebo solution


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2% Squaric Acid Sensitization<br>2% Squaric Acid solution will be applied for sensitization to the inner arm. | Drug: Squaric Acid solution<br> <br> * Other names: SADBE;|
| Placebo Comparator: Placebo Solution<br>Patients in placebo group will be given dimethyl sulfoxide. | Drug: Placebo solution<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |