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

Exclusion Criteria

• •Self report having four or more episodes of herpes labialis in the past 12 months
• •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.