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

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.