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

Description

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.

Study Start Date

December, 01 2016

Estimated Completion Date

June 2018

Interventions

  • Drug: SADBE
  • Other: Placebo

Study ID

Squarex, LLC -- P2a

Status

Recruiting

Trial ID

NCT02965781

Study Type

Interventional

Trial Phase

Phase 1/Phase 2

Enrollment Quota

94

Sponsor

Squarex, LLC

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.

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (7)

Study Location Distance Name Phone Email
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Maria AloraPalli MD 617-726-5066 harvardskinstudies@partners.org
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Maria AloraPalli MD 617-726-5066 harvardskinstudies@partners.org
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Maria AloraPalli MD 617-726-5066 harvardskinstudies@partners.org
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Maria AloraPalli MD 617-726-5066 harvardskinstudies@partners.org
Stanford Medicine Outpatient Center - Redwood City, California 2,694.5 miles Linna Ling Gaun 650-721-7195 linna@stanford.edu
Stanford Medicine Outpatient Center - Redwood City, California 2,694.5 miles Linna Ling Gaun 650-721-7195 linna@stanford.edu
Stanford Medicine Outpatient Center - Redwood City, California 2,694.5 miles Linna Ling Gaun 650-721-7195 linna@stanford.edu

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