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

NCT ID: NCT02965781

Last Updated: 2021-11-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 139 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2018-12-20

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.

Conditions

Herpes Labialis; Cold Sore

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

SADBE

Intervention Type: DRUG

Topical solution

Placebo

Intervention Type: OTHER

Topical solution

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.

Group Type: ACTIVE_COMPARATOR

SADBE

Intervention Type: DRUG

Topical solution

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Topical solution

Interventions

SADBE

Topical solution

Intervention Type: DRUG

Placebo

Topical solution

Intervention Type: OTHER

Other Intervention Names

Squaric acid dibutyl ester; Vehicle-DMSO

Eligibility Criteria

Inclusion Criteria

• Age ≥18

Exclusion Criteria

• Self report having four or more episodes of herpes labialis in the past 12 months

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Squarex, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hugh McTavish, PhD, JD

Role: STUDY_DIRECTOR

Squarex, LLC

Thomas D Horn, MD

Role: STUDY_CHAIR

Squarex, LLC

Locations

Stanford Medicine Outpatient Center

Redwood City, California, United States

International Research Partners, LLC

Doral, Florida, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Quality Clinical Research, Inc

Omaha, Nebraska, United States

Advantage Clinical Trials

The Bronx, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

P2a

Identifier Type: -

Identifier Source: org_study_id