Back to resultsSafety and Efficacy of Squaric Acid Dibutyl Ester for the Treatment of Herpes Labialis (Squarex)
Primary Purpose
Herpes Labialis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Squaric Acid solution
Placebo solution
Sponsored by
About this trial
This is an interventional treatment trial for Herpes Labialis
Eligibility Criteria
Inclusion Criteria:
- Age >18
- With clinical diagnosis of herpes labialis.
- who self report having six or more episodes of herpes labialis in the previous 12 months.
Exclusion Criteria:
- Pregnant or lactating females.
- Current or recurrent 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 immunosuppressant at time of recruitment or within past 4 weeks, except for inhaled corticosteroids for asthma.
- History of malignancy (except patients with surgically cured basal cell or squamous cell skin cancers who will be eligible)
- History of organ transplantation
- Negative HIV-positive status determined by history at screening or known history of any other immuno-suppressing disease.
- Severe comorbidities (diabetes mellitus requiring insulin, CHF (EF<50% at baseline will be exclusionary) of any severity, MI, CVA or TIA within 3 months of screening visit, unstable angina pectoris, oxygen-dependent severe pulmonary disease
- 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.
- Subjects who have known hypersensitivity to Squaric acid or any of its components.
- History of recent alcohol or substance abuse (< 1 year)
- Any condition judged by the investigator to cause this clinical trial to be detrimental to the patient.
- History of psychiatric disease that would interfere with the patient's ability to comply with the study protocol
- History of non-compliance with other therapies.
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
2% Squaric Acid Sensitization
Placebo Solution
Arm Description
2% Squaric Acid solution will be applied for sensitization to the inner arm.
Patients in placebo group will be given dimethyl sulfoxide.
Outcomes
Primary Outcome Measures
Subjects With at Least One Form of Contact With Study Staff With no Herpes Labialis Outbreaks Within 119 Days of Sensitization
Percent of subjects with no reported herpes labialis outbreak within 119 days of sensitization over total number of subjects after one form of contact with study staff
Secondary Outcome Measures
Number of Adverse Events Reported
To assess the safety and tolerability of squaric acid solution the number of adverse events in each treatment arm will be collected and compared.
Full Information
NCT ID
NCT01971385
First Posted
October 17, 2013
Last Updated
May 5, 2017
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01971385
Brief Title
Safety and Efficacy of Squaric Acid Dibutyl Ester for the Treatment of Herpes Labialis
Acronym
Squarex
Official Title
A Clinical Trial to Test the Safety and Efficacy of Squaric Acid Dibutyl Ester for the Treatment of Herpes Labialis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Subjects with a history of recurrent herpes labialis will be sensitized with either 2% SADBE or placebo. Following this, subjects sensitized with 2% SADBE will received.2% sqauric acid or.5% squaric acid on their cold sore within 72 hours of a recurrence. Subjects sensitized with placebo solution will receive placebo solution on their cold sore within 72 hours of a recurrence. Subjects will be followed for up to 6 mos after application of study medication.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpes Labialis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2% Squaric Acid Sensitization
Arm Type
Active Comparator
Arm Description
2% Squaric Acid solution will be applied for sensitization to the inner arm.
Arm Title
Placebo Solution
Arm Type
Placebo Comparator
Arm Description
Patients in placebo group will be given dimethyl sulfoxide.
Intervention Type
Drug
Intervention Name(s)
Squaric Acid solution
Other Intervention Name(s)
Squaric Acid Dibutyl Ester solution, SADBE
Intervention Type
Drug
Intervention Name(s)
Placebo solution
Primary Outcome Measure Information:
Title
Subjects With at Least One Form of Contact With Study Staff With no Herpes Labialis Outbreaks Within 119 Days of Sensitization
Description
Percent of subjects with no reported herpes labialis outbreak within 119 days of sensitization over total number of subjects after one form of contact with study staff
Time Frame
8 months
Secondary Outcome Measure Information:
Title
Number of Adverse Events Reported
Description
To assess the safety and tolerability of squaric acid solution the number of adverse events in each treatment arm will be collected and compared.
Time Frame
8 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age >18
With clinical diagnosis of herpes labialis.
who self report having six or more episodes of herpes labialis in the previous 12 months.
Exclusion Criteria:
Pregnant or lactating females.
Current or recurrent 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 immunosuppressant at time of recruitment or within past 4 weeks, except for inhaled corticosteroids for asthma.
History of malignancy (except patients with surgically cured basal cell or squamous cell skin cancers who will be eligible)
History of organ transplantation
Negative HIV-positive status determined by history at screening or known history of any other immuno-suppressing disease.
Severe comorbidities (diabetes mellitus requiring insulin, CHF (EF<50% at baseline will be exclusionary) of any severity, MI, CVA or TIA within 3 months of screening visit, unstable angina pectoris, oxygen-dependent severe pulmonary disease
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.
Subjects who have known hypersensitivity to Squaric acid or any of its components.
History of recent alcohol or substance abuse (< 1 year)
Any condition judged by the investigator to cause this clinical trial to be detrimental to the patient.
History of psychiatric disease that would interfere with the patient's ability to comply with the study protocol
History of non-compliance with other therapies.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandra B Kimball, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of Squaric Acid Dibutyl Ester for the Treatment of Herpes Labialis
We'll reach out to this number within 24 hrs