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

• ClinicalTrials.gov Identifier: NCT01971385
• Recruitment Status: Completed
• First Posted: October 29, 2013
• Results First Posted: October 2, 2017
• Last Update Posted: October 2, 2017
• Sponsor: Massachusetts General Hospital
• Information provided by (Responsible Party): Alexandra Kimball, Massachusetts General Hospital

Tracking Information

• First Submitted Date: October 17, 2013
• First Posted Date: October 29, 2013
• Results First Submitted Date: March 23, 2017
• Results First Posted Date: October 2, 2017
• Last Update Posted Date: October 2, 2017
• Study Start Date: October 2013
• Actual Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 5, 2017)

Subjects With at Least One Form of Contact With Study Staff With no Herpes Labialis Outbreaks Within 119 Days of Sensitization [ Time Frame: 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

Original Primary Outcome Measures (submitted: October 23, 2013)

Number of days with lesions [ Time Frame: 8 months ]

Determine the effect of squaric acid on frequency and severity of herpes labialis outbreaks compared to placebo in terms of number of days with lesions during the 8 months after the last treatment.

Current Secondary Outcome Measures (submitted: May 5, 2017)

Number of Adverse Events Reported [ Time Frame: 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.

Original Secondary Outcome Measures (submitted: October 23, 2013)

• Number of days until first subject-reported recurrence. [ Time Frame: 8 months ]
  Determine the effect of squaric acid on frequency and severity of herpes labialis outbreaks compared to placebo in terms of number of days until first subject-reported recurrence (distinct new outbreak) after the last treatment.
• Number of adverse events reported [ Time Frame: 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.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Safety and Efficacy of Squaric Acid Dibutyl Ester for the Treatment of Herpes Labialis
• Official Title: A Clinical Trial to Test the Safety and Efficacy of Squaric Acid Dibutyl Ester for the Treatment of Herpes Labialis
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Herpes Labialis

Intervention

• Drug: Squaric Acid solution
  Other Names:

  • Squaric Acid Dibutyl Ester solution
  • SADBE
• Drug: Placebo solution

Study Arms

• Active Comparator: 2% Squaric Acid Sensitization
  2% Squaric Acid solution will be applied for sensitization to the inner arm.
  Intervention: Drug: Squaric Acid solution
• Placebo Comparator: Placebo Solution
  Patients in placebo group will be given dimethyl sulfoxide.
  Intervention: Drug: Placebo solution

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 5, 2017): 54
• Original Estimated Enrollment (submitted: October 23, 2013): 60
• Actual Study Completion Date: September 2015
• Actual Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01971385
• Other Study ID Numbers: 2013P001028
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Alexandra Kimball, Massachusetts General Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Massachusetts General Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Massachusetts General Hospital
• Verification Date: May 2017