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Double-blind, Vehicle-controlled Study of the Efficacy and Safety of SADBE in Subjects With Recurrent Herpes Labialis (P2a)

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: NCT02965781
Recruitment Status : Unknown
Verified February 2018 by Squarex, LLC.
Recruitment status was:  Active, not recruiting
First Posted : November 17, 2016
Last Update Posted : February 22, 2018
Sponsor:
Information provided by (Responsible Party):
Squarex, LLC

Brief Summary:
This study evaluates the safety and efficacy of SADBE in the prevention of recurrent herpes labialis in adults. Two-thirds of the participants will receive a SADBE solution, while the other third will receive only the vehicle as a placebo control. The solutions will be administered topically to the patient's arms. The study will compare a single-arm application versus a two-arm application versus two placebo doses on the arm.

Condition or disease Intervention/treatment Phase
Herpes Labialis Cold Sore Drug: SADBE Other: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 2, Multi-site, Randomized, Double-blind, Vehicle-controlled Study of the Efficacy and Safety of Squaric Acid Dibutyl Ester (SADBE) in Subjects With Recurrent Herpes Labialis - Single Versus Two-dose Arm Application
Study Start Date : December 2016
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cold Sores

Arm Intervention/treatment
Active Comparator: One SADBE application
Patient will receive a topical 2% SADBE sensitization dose applied to the patient's upper arm. Three weeks after topical sensitization dose patient will receive topical placebo applied to the patient's upper arm.
Drug: SADBE
Topical solution
Other Name: Squaric acid dibutyl ester

Other: Placebo
Topical solution
Other Name: Vehicle-DMSO

Active Comparator: Two SADBE applications
Patient will receive a topical 2% SADBE sensitization dose applied to the patient's upper arm. A 0.5% SADBE intensification dose will be applied to the patient's upper arm 3 weeks after sensitization dose.
Drug: SADBE
Topical solution
Other Name: Squaric acid dibutyl ester

Placebo Comparator: Placebo application (DMSO only-No SADBE)
Patient will receive a topical placebo (vehicle-DMSO) dose applied to the patient's upper arm. A topical placebo (vehicle-DMSO) follow up dose will be applied to the patient's upper arm 3 weeks after the first placebo dose dose.
Other: Placebo
Topical solution
Other Name: Vehicle-DMSO




Primary Outcome Measures :
  1. Days between the first drug dose and onset of next new herpes labialis (cold sore) episode up to 12 months [ Time Frame: From day 1 sensitization dose to new herpes labialis episode up to 12 months ]
    The number of days until a patient reports his or her first new herpes labialis episode following the sensitization dose up to 12 months


Secondary Outcome Measures :
  1. Days between the second drug dose and onset of next new herpes labialis (cold sore) episode that begins after the second drug dose [ Time Frame: 12 months ]
    The number of new herpes labialis episodes during the 12-month follow up period following the first drug dose



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥18
  • Clinical diagnosis of herpes labialis, which may be made at the screening visit based on the patient's self-reported history of symptoms. An active herpes labialis outbreak at the time of entry into the clinical trial will neither be required nor will be an exclusion criteria.
  • Self report having four or more episodes of herpes labialis in the past 12 months

Exclusion Criteria:

  • People that have had treatment with anti viral therapy within 2 weeks before sensitization dose.
  • Pregnant or lactating females.
  • Current or recurrent non-herpetic 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 immunosuppressants at time of recruitment or within past 4 weeks, except for inhaled corticosteroids for asthma or topical steroids in sites other than face.
  • History of malignancy (except patients with surgically cured basal cell or squamous cell skin cancers)
  • History of organ transplantation
  • HIV-positive status determined by history at screening or known history of any other immunosuppressive disease.
  • Severe co-morbidities (diabetes mellitus requiring insulin, CHF (EF<50% at baseline will be exclusionary) MI, CVA or TIA within 3 months of screening visit, unstable angina pectoris, oxygen-dependent severe pulmonary disease
  • History of exposure to squaric acid or squaric acid dibutyl ester.
  • Known hypersensitivity to DMSO
  • Any condition judged by the investigator to cause this clinical trial to be detrimental to the patient.
  • 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.
  • Previous or current participation in a clinical trial of SADBE to treat herpes labialis.

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): NCT02965781


Locations
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United States, California
Stanford Medicine Outpatient Center
Redwood City, California, United States, 94063
United States, Florida
International Research Partners, LLC
Doral, Florida, United States, 33166
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Nebraska
Quality Clinical Research, Inc
Omaha, Nebraska, United States, 68114
United States, New York
Advantage Clinical Trials
Bronx, New York, United States, 10468
Sponsors and Collaborators
Squarex, LLC
Investigators
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Study Director: Hugh McTavish, PhD, JD Squarex, LLC
Study Chair: Thomas D Horn, MD Squarex, LLC
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Responsible Party: Squarex, LLC
ClinicalTrials.gov Identifier: NCT02965781    
Other Study ID Numbers: P2a
First Posted: November 17, 2016    Key Record Dates
Last Update Posted: February 22, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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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
Squaric acid dibutyl ester
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs