Back to resultsDouble-blind, Vehicle-controlled Study of the Efficacy and Safety of SADBE in Subjects With Recurrent Herpes Labialis (P2a)
Primary Purpose
Herpes Labialis, Cold Sore
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SADBE
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Herpes Labialis
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.
Sites / Locations
- Stanford Medicine Outpatient Center
- International Research Partners, LLC
- Massachusetts General Hospital
- Quality Clinical Research, Inc
- Advantage Clinical Trials
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
One SADBE application
Two SADBE applications
Placebo application (DMSO only-No SADBE)
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02965781
Brief Title
Double-blind, Vehicle-controlled Study of the Efficacy and Safety of SADBE in Subjects With Recurrent Herpes Labialis
Acronym
P2a
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
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
December 20, 2018 (Actual)
Study Completion Date
December 20, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Squarex, LLC
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpes Labialis, Cold Sore
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
139 (Actual)
8. Arms, Groups, and Interventions
Arm Title
One SADBE application
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Two SADBE applications
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo application (DMSO only-No SADBE)
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
SADBE
Other Intervention Name(s)
Squaric acid dibutyl ester
Intervention Description
Topical solution
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Vehicle-DMSO
Intervention Description
Topical solution
Primary Outcome Measure Information:
Title
Days to Next Herpes Labialis (Cold Sore) Episode From 43 Days After the First Dose up to 121 Days After the First Dose
Description
The number of days until a patient reports his or her first new herpes labialis episode from 43 - 121 days following the first dose
Time Frame
43 - 121 days after the first dose
Secondary Outcome Measure Information:
Title
Number of Outbreaks Beginning 43 Days After the First Dose up to 12 Months
Description
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
Time Frame
From day 43 after the first dose up to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hugh McTavish, PhD, JD
Organizational Affiliation
Squarex, LLC
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Thomas D Horn, MD
Organizational Affiliation
Squarex, LLC
Official's Role
Study Chair
Facility Information:
Facility Name
Stanford Medicine Outpatient Center
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Facility Name
International Research Partners, LLC
City
Doral
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Quality Clinical Research, Inc
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Advantage Clinical Trials
City
Bronx
State/Province
New York
ZIP/Postal Code
10468
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Double-blind, Vehicle-controlled Study of the Efficacy and Safety of SADBE in Subjects With Recurrent Herpes Labialis
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