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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alexandra Kimball, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01971385
First received: October 17, 2013
Last updated: September 16, 2015
Last verified: September 2015
  Purpose
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 Intervention Phase
Herpes Labialis
Drug: Squaric Acid solution
Drug: Placebo solution
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Number of days with lesions [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Number of days until first subject-reported recurrence. [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    To assess the safety and tolerability of squaric acid solution the number of adverse events in each treatment arm will be collected and compared.


Estimated Enrollment: 60
Study Start Date: October 2013
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 0.2% Squaric Acid
0.2% Squaric Acid solution disolved in dimethyl sulfoxide will be applied
Drug: Squaric Acid solution
Other Names:
  • Squaric Acid Dibutyl Ester solution
  • SADBE
Active Comparator: 0.5% Squaric Acid
0.5% Squaric Acid solution disolved in dimethyl sulfoxide will be applied
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: October 17, 2013
Last Updated: September 16, 2015
Health Authority: United States: Food and Drug Administration

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
Dimethyl Sulfoxide
Squaric acid dibutyl ester
Cryoprotective Agents
Protective Agents
Physiological Effects of Drugs
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Adjuvants, Immunologic
Immunologic Factors

ClinicalTrials.gov processed this record on December 02, 2016