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

Phase 1

Completed

Brief Summary: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
2% Squaric Acid Sensitization	Squaric Acid solution	2% Squaric Acid solution will be applied for sensitization to the inner arm.
Placebo Solution	Placebo solution	Patients in placebo group will be given dimethyl sulfoxide.

Primary Outcome Measures

Name	Time	Method
Subjects With at Least One Form of Contact With Study Staff With no Herpes Labialis Outbreaks Within 119 Days of Sensitization	8 months	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

Secondary Outcome Measures

Name	Time	Method
Number of Adverse Events Reported	8 months	To assess the safety and tolerability of squaric acid solution the number of adverse events in each treatment arm will be collected and compared.