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

NCT ID: NCT01971385

Last Updated: 2017-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2015-09-30

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.

Conditions

Herpes Labialis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

2% Squaric Acid Sensitization

2% Squaric Acid solution will be applied for sensitization to the inner arm.

Group Type: ACTIVE_COMPARATOR

Squaric Acid solution

Intervention Type: DRUG

Placebo Solution

Patients in placebo group will be given dimethyl sulfoxide.

Group Type: PLACEBO_COMPARATOR

Placebo solution

Intervention Type: DRUG

Interventions

Squaric Acid solution

Intervention Type: DRUG

Placebo solution

Intervention Type: DRUG

Other Intervention Names

Squaric Acid Dibutyl Ester solution; SADBE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Alexandra Kimball

Director, Clinical Unit for Research Trials in Skin

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alexandra B Kimball, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2013P001028

Identifier Type: -

Identifier Source: org_study_id