Safety and Efficacy of Squaric Acid Dibutyl Ester for the Treatment of Herpes Labialis (Squarex)
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ClinicalTrials.gov Identifier: NCT01971385 |
Recruitment Status :
Completed
First Posted : October 29, 2013
Results First Posted : October 2, 2017
Last Update Posted : October 2, 2017
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Condition or disease | Intervention/treatment | Phase |
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Herpes Labialis | Drug: Squaric Acid solution Drug: Placebo solution | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 54 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, 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 |
Study Start Date : | October 2013 |
Actual Primary Completion Date : | September 2015 |
Actual Study Completion Date : | September 2015 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 2% Squaric Acid Sensitization
2% Squaric Acid solution will be applied for sensitization to the inner arm.
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Drug: Squaric Acid solution
Other Names:
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Placebo Comparator: Placebo Solution
Patients in placebo group will be given dimethyl sulfoxide.
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Drug: Placebo solution |
- Subjects With at Least One Form of Contact With Study Staff With no Herpes Labialis Outbreaks Within 119 Days of Sensitization [ Time Frame: 8 months ]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
- Number of Adverse Events Reported [ Time Frame: 8 months ]To assess the safety and tolerability of squaric acid solution the number of adverse events in each treatment arm will be collected and compared.

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01971385
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 |
Principal Investigator: | Alexandra B Kimball, MD | Massachusetts General Hospital |
Responsible Party: | Alexandra Kimball, Director, Clinical Unit for Research Trials in Skin, Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT01971385 |
Other Study ID Numbers: |
2013P001028 |
First Posted: | October 29, 2013 Key Record Dates |
Results First Posted: | October 2, 2017 |
Last Update Posted: | October 2, 2017 |
Last Verified: | May 2017 |
Herpes Simplex Herpes Labialis Herpesviridae Infections DNA Virus Infections Virus Diseases Infections Skin Diseases, Viral Skin Diseases, Infectious Skin Diseases |
Lip Diseases Mouth Diseases Stomatognathic Diseases Pharmaceutical Solutions Squaric acid dibutyl ester Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs |