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

Phase 1

Completed

• Conditions: Herpes Labialis; Cold Sore
• Interventions: Drug: SADBE; Other: Placebo

• Registration Number: NCT02965781
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-24
• Study First Submitted QC: 2016-11-14
• Study First Posted: 2016-11-17
• Study Start: 2016-12
• Primary Completion: 2018-12-20
• Study Completion: 2018-12-20
• Results First Submitted: 2021-05-19
• Status Verified: 2021-10
• Results First Submitted QC: 2021-10-03
• Last Update Submitted: 2021-10-03
• Results First Posted: 2021-11-02
• Last Update Posted: 2021-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 139

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
One SADBE application	SADBE	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.
One SADBE application	Placebo	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.
Two SADBE applications	SADBE	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.
Placebo application (DMSO only-No SADBE)	Placebo	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.

Primary Outcome Measures

Name	Time	Method
Days to Next Herpes Labialis (Cold Sore) Episode From 43 Days After the First Dose up to 121 Days After the First Dose	43 - 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

Secondary Outcome Measures

Name	Time	Method
Number of Outbreaks Beginning 43 Days After the First Dose up to 12 Months	From day 43 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

Trial Locations

Locations (5)

Stanford Medicine Outpatient Center; 🇺🇸 Redwood City, California, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

International Research Partners, LLC; 🇺🇸 Doral, Florida, United States

Advantage Clinical Trials; 🇺🇸 Bronx, New York, United States

Quality Clinical Research, Inc; 🇺🇸 Omaha, Nebraska, United States