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

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

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.

Study Overview

• Status: Completed
• Conditions: Herpes Labialis
• Intervention / Treatment: Drug: Placebo solution; Drug: Squaric Acid solution

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 2% Squaric Acid Sensitization; 2% Squaric Acid solution will be applied for sensitization to the inner arm.	Drug: Squaric Acid solution; Other Names: SADBE; Squaric Acid Dibutyl Ester solution
Placebo Comparator: Placebo Solution; Patients in placebo group will be given dimethyl sulfoxide.	Drug: Placebo solution

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Alexandra B Kimball, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: October 17, 2013
• First Submitted That Met QC Criteria: October 23, 2013
• First Posted (Estimate): October 29, 2013

Study Record Updates

• Last Update Posted (Actual): October 2, 2017
• Last Update Submitted That Met QC Criteria: May 5, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Virus Diseases; Infections; Stomatognathic Diseases; Mouth Diseases; DNA Virus Infections; Skin Diseases, Infectious; Skin Diseases, Viral; Herpesviridae Infections; Lip Diseases; Herpes Simplex; Herpes Labialis; Physiological Effects of Drugs; Immunologic Factors; Adjuvants, Immunologic; Pharmaceutical Solutions; Squaric acid dibutyl ester
• Other Study ID Numbers: 2013P001028