Safety and Efficacy of Squaric Acid Dibutyl Ester for the Treatment of Herpes Labialis - Full Text View

Purpose

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.

Condition	Intervention	Phase
Herpes Labialis	Drug: Squaric Acid solution Drug: Placebo solution	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Clinical Trial to Test the Safety and Efficacy of Squaric Acid Dibutyl Ester for the Treatment of Herpes Labialis

Resource links provided by NLM:

MedlinePlus related topics: Cold Sores

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

Number of days with lesions [ Time Frame: 8 months ] [ Designated as safety issue: No ]
Determine the effect of squaric acid on frequency and severity of herpes labialis outbreaks compared to placebo in terms of number of days with lesions during the 8 months after the last treatment.

Secondary Outcome Measures:

Number of days until first subject-reported recurrence. [ Time Frame: 8 months ] [ Designated as safety issue: No ]
Determine the effect of squaric acid on frequency and severity of herpes labialis outbreaks compared to placebo in terms of number of days until first subject-reported recurrence (distinct new outbreak) after the last treatment.
Number of adverse events reported [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]
To assess the safety and tolerability of squaric acid solution the number of adverse events in each treatment arm will be collected and compared.


Estimated Enrollment:	60
Study Start Date:	October 2013
Study Completion Date:	September 2015
Primary Completion Date:	September 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 0.2% Squaric Acid 0.2% Squaric Acid solution disolved in dimethyl sulfoxide will be applied	Drug: Squaric Acid solution Other Names: Squaric Acid Dibutyl Ester solution SADBE
Active Comparator: 0.5% Squaric Acid 0.5% Squaric Acid solution disolved in dimethyl sulfoxide will be applied	Drug: Squaric Acid solution Other Names: Squaric Acid Dibutyl Ester solution SADBE
Placebo Comparator: Placebo Solution Patients in placebo group will be given dimethyl sulfoxide.	Drug: Placebo solution

Eligibility


Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01971385

Locations


United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Massachusetts General Hospital

Investigators


Principal Investigator:	Alexandra B Kimball, MD	Massachusetts General Hospital

More Information


Responsible Party:	Alexandra Kimball, Director, Clinical Unit for Research Trials in Skin, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT01971385 History of Changes
Other Study ID Numbers:	2013P001028
Study First Received:	October 17, 2013
Last Updated:	September 16, 2015
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


Herpes Labialis Herpes Simplex Herpesviridae Infections DNA Virus Infections Virus Diseases Skin Diseases, Viral Lip Diseases Mouth Diseases Stomatognathic Diseases Skin Diseases, Infectious Skin Diseases	Pharmaceutical Solutions Dimethyl Sulfoxide Squaric acid dibutyl ester Cryoprotective Agents Protective Agents Physiological Effects of Drugs Free Radical Scavengers Antioxidants Molecular Mechanisms of Pharmacological Action Adjuvants, Immunologic Immunologic Factors

ClinicalTrials.gov processed this record on September 28, 2016

Safety and Efficacy of Squaric Acid Dibutyl Ester for the Treatment of Herpes Labialis (Squarex)