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

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

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 Overview

• Status: Completed
• Conditions: Herpes Labialis; Cold Sore
• Intervention / Treatment: Drug: SADBE; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 139
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Redwood City, California, United States, 94063
      • Stanford Medicine Outpatient Center
  • Florida
    • Doral, Florida, United States, 33166
      • International Research Partners, LLC
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Quality Clinical Research, Inc
  • New York
    • Bronx, New York, United States, 10468
      • Advantage Clinical Trials

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: Squaric acid dibutyl ester; Other: Placebo; Topical solution; Other Names: 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 Names: 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 Names: Vehicle-DMSO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Days to Next Herpes Labialis (Cold Sore) Episode From 43 Days After the First Dose up to 121 Days After the First Dose	The number of days until a patient reports his or her first new herpes labialis episode from 43 - 121 days following the first dose	43 - 121 days after the first dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Outbreaks Beginning 43 Days After the First Dose up to 12 Months	The number of new herpes labialis episodes per subject during the 12-month follow up period following the first drug dose, beginning day 43 after the first dose	From day 43 after the first dose up to 12 months

Collaborators and Investigators

• Sponsor: Squarex, LLC
• Investigators: Study Director: Hugh McTavish, PhD, JD, Squarex, LLC; Study Chair: Thomas D Horn, MD, Squarex, LLC

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): December 20, 2018
• Study Completion (Actual): December 20, 2018

Study Registration Dates

• First Submitted: October 24, 2016
• First Submitted That Met QC Criteria: November 14, 2016
• First Posted (Estimate): November 17, 2016

Study Record Updates

• Last Update Posted (Actual): November 2, 2021
• Last Update Submitted That Met QC Criteria: October 3, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Virus Diseases; Infections; Stomatognathic Diseases; Mouth Diseases; DNA Virus Infections; Skin Diseases, Infectious; Skin Diseases, Viral; Herpesviridae Infections; Lip Diseases; Herpes Simplex; Herpes Labialis; Physiological Effects of Drugs; Immunologic Factors; Adjuvants, Immunologic; Squaric acid dibutyl ester
• Other Study ID Numbers: P2a

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided