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

Mass General Brigham

Status and phase: Completed; Phase 1

Conditions: Herpes Labialis

Treatments: Drug: Squaric Acid solution; Drug: Placebo solution

Study type: Interventional

Funder types: Other

Identifiers

NCT01971385

2013P001028

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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54 participants in 2 patient groups, including a placebo group

2% Squaric Acid Sensitization

Active Comparator group

Description:

2% Squaric Acid solution will be applied for sensitization to the inner arm.

Treatment:

Drug: Squaric Acid solution

Placebo Solution

Placebo Comparator group

Description:

Patients in placebo group will be given dimethyl sulfoxide.

Treatment:

Drug: Placebo solution