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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Information provided by (Responsible Party):
Alexandra Kimball, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE October 17, 2013
First Posted Date  ICMJE October 29, 2013
Results First Submitted Date  ICMJE March 23, 2017
Results First Posted Date  ICMJE October 2, 2017
Last Update Posted Date October 2, 2017
Study Start Date  ICMJE October 2013
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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.
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE Safety and Efficacy of Squaric Acid Dibutyl Ester for the Treatment of Herpes Labialis
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Herpes Labialis
Intervention  ICMJE
  • Drug: Squaric Acid solution
    Other Names:
    • Squaric Acid Dibutyl Ester solution
    • SADBE
  • Drug: Placebo solution
Study Arms  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 5, 2017)
54
Original Estimated Enrollment  ICMJE
 (submitted: October 23, 2013)
60
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01971385
Other Study ID Numbers  ICMJE 2013P001028
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alexandra Kimball, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alexandra B Kimball, MD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP