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

NCT02965781 | Completed Phase 1 Results DMC

• 1 other identifier: P2a
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 5

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (3)

One SADBE application

ACTIVE COMPARATOR

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; Other: Placebo

Two SADBE applications

ACTIVE COMPARATOR

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

Placebo application (DMSO only-No SADBE)

PLACEBO COMPARATOR

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

Interventions

SADBE DRUG

Topical solution

Also known as: Squaric acid dibutyl ester

One SADBE application; Two SADBE applications

Placebo OTHER

Topical solution

Also known as: Vehicle-DMSO

One SADBE application; Placebo application (DMSO only-No SADBE)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Squarex, LLC: lead

Study Sites (5)

Stanford Medicine Outpatient Center

Redwood City, California, 94063, United States

Location

International Research Partners, LLC

Doral, Florida, 33166, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Quality Clinical Research, Inc

Omaha, Nebraska, 68114, United States

Location

Advantage Clinical Trials

The Bronx, New York, 10468, United States

Location

MeSH Terms

Conditions

Herpes Labialis

Interventions

squaric acid dibutyl ester

Condition Hierarchy (Ancestors)

Herpes Simplex; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Hugh McTavish
• Organization: Squarex LLC

hmctavish@squarex-pharma.com

6512078270

Study Officials

• Hugh McTavish, PhD, JD

  Squarex, LLC

  STUDY DIRECTOR

• Thomas D Horn, MD

  Squarex, LLC

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2016
• First Posted: November 17, 2016
• Study Start: December 1, 2016
• Primary Completion: December 20, 2018
• Study Completion: December 20, 2018
• Last Updated: November 2, 2021
• Results First Posted: November 2, 2021

Record last verified: 2021-10

Locations

US (5)