Clinical trial NCT02965781: Double-blind, Vehicle-controlled Study of the Efficacy and Safety of SADBE in Subjects With Recurrent Herpes Labialis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Herpes Labialis
Cold Sore
Lead sponsor: Squarex, LLC
Sponsor class: INDUSTRY
First posted: 2016-11-17
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: Days to Next Herpes Labialis (Cold Sore) Episode From 43 Days After the First Dose up to 121 Days After the First Dose
timeFrame: 43 - 121 days after the first dose
Secondary outcomes:
measure: Number of Outbreaks Beginning 43 Days After the First Dose up to 12 Months
timeFrame: From day 43 after the first dose up to 12 months
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Stanford Medicine Outpatient Center
state: California
city: Doral
country: United States
facility: International Research Partners, LLC
state: Florida
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Omaha
country: United States
facility: Quality Clinical Research, Inc
state: Nebraska
city: Bronx
country: United States
facility: Advantage Clinical Trials
state: New York
Study officials:
affiliation: Squarex, LLC
name: Hugh McTavish, PhD, JD
role: STUDY_DIRECTOR
affiliation: Squarex, LLC
name: Thomas D Horn, MD
role: STUDY_CHAIR
References: