Overview

A Phase 2, Muti-Center Study of Repeat Dosing of Squaric Acid Dibutyl Ester in Subjects With Herpes Labialis

Status:
Terminated
Trial end date:
2019-10-05
Target enrollment:
0
Participant gender:
All
Summary
Primary Objective: To assess local and generalized adverse events with repeat topical application of 2% and 0.5% squaric acid dibutyl ester (SADBE) in subjects with frequent herpes labialis (4 or more episodes in the previous 12 months). Secondary Objective: To assess efficacy of repeat topical application of 2% and 0.5% SADBE in the prevention of herpes labialis episodes.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Squarex, LLC
Treatments:
Squaric acid dibutyl ester
Criteria
Inclusion Criteria:

1. Age ≥ 18 and ≤ 65

2. 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 criterion.

3. Self report having four (4) or more episodes of herpes labialis in the past 12 months.

Subjects will NOT be told that four-or-more episodes in the previous 12 months is the
entry criterion. Subjects will be asked "How many separate episodes of cold sores have
you had in the previous 12 months?" They will be included if they give an answer of
four or more and excluded if they give an answer of three or fewer.

4. At least half of the subject's episodes of the previous 12 months should be vesicular
in nature and at least half preceded by prodromal symptoms. Prodromal symptoms may
include tingling, itching, burning or pain before the development of a herpetic
lesion.

Exclusion Criteria:

1. Pregnant or lactating females.

2. 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 in the last 12 months.

3. Therapy with glucocorticoid or immunosuppressants at time of recruitment or within
past 4 weeks prior to the screening visit, or at any time during the study (including
inhaled corticosteroids for asthma), except for topical steroids in sites other than
face.

4. History of malignancy (except patients with surgically cured basal cell or squamous
cell skin cancers).

5. History of organ transplantation.

6. HIV-positive status determined by history at screening or known history of any other
immunosuppressive disease.

7. Severe co-morbidities (CHF [NYHA class II or worse], MI, CVA or TIA) within 3 months
of screening visit, current unstable angina pectoris or oxygen-dependent severe
pulmonary disease.

8. Known hypersensitivity to Dimethyl sulfoxide (DMSO).

9. Any condition judged by the investigator to cause this clinical trial to be
detrimental to the patient.

10. Subject is currently enrolled in another investigational device or drug trial(s), or
subject has received other investigational agent(s) within 28 days of the screening
visit.

11. Previous exposure to SADBE (squaric acid or squaric acid dibutyl ester).

12. Subject has an abnormal skin condition (e.g., acne, eczema, rosacea, psoriasis,
albinism, or chronic vesiculo-bullous disorder) that occurs in the area ordinarily
affected by herpes labialis

13. Subject has an abnormal skin condition (e.g., eczema, rosacea, psoriasis, albinism, or
chronic vesiculo-bullous disorder) that occurs in the inner aspect of either upper arm
(the area where drug will be applied).

14. Subject has had a vaccine for either HSV-1 or HSV-2.

15. Subject has had treatment with anti-viral therapy (including ABREVA) within 2 weeks
before first dose of SADBE or at any time during the study.