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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):

Study Description
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.

Condition or disease Intervention/treatment Phase
Herpes Labialis Drug: Squaric Acid solution Drug: Placebo solution Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Clinical Trial to Test the Safety and Efficacy of Squaric Acid Dibutyl Ester for the Treatment of Herpes Labialis
Study Start Date : October 2013
Primary Completion Date : September 2015
Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cold Sores
U.S. FDA Resources

Arms and Interventions

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:
  • Squaric Acid Dibutyl Ester solution
  • SADBE
Placebo Comparator: Placebo Solution
Patients in placebo group will be given dimethyl sulfoxide.
Drug: Placebo solution


Outcome Measures

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01971385


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Alexandra B Kimball, MD Massachusetts General Hospital
More Information

Responsible Party: Alexandra Kimball, Director, Clinical Unit for Research Trials in Skin, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01971385     History of Changes
Other Study ID Numbers: 2013P001028
First Posted: October 29, 2013    Key Record Dates
Results First Posted: October 2, 2017
Last Update Posted: October 2, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Herpes Labialis
Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Lip Diseases
Mouth Diseases
Stomatognathic Diseases
Skin Diseases, Infectious
Skin Diseases
Pharmaceutical Solutions
Squaric acid dibutyl ester
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs