A Randomized, Efficacy Assessor-Blinded, Study to Assess Preliminary Efficacy and Safety of EDTA Eye Drops v. an Active Comparator in the Suppression of Herpes Simplex Virus Eruptions in Subjects With a History of Herpes Labialis

IRB_00120663

This will be a randomized, efficacy assessor-blinded, parallel group, pilot study of up to 20 subjects with documented herpes labialis. Patients will be treated with the study drug, EDTA Eye Drops or the active comparator of Abreva. Potential subjects will be assessed during a screening visit that must take place no greater than 2 weeks prior to the Day 1 (Baseline) visit. During the screening period, subjects that meet all other entry criteria will undergo UV susceptibility testing to determine their individual MED (minimal erythemal dose). UV susceptibility testing takes place over two days with exposure to UV light on specified regions on the subject's back followed by an assessment of the exposed areas 24 hours later to identify the MED. Subjects who have a measurable MED will be allowed to enroll in the study. Each subject will be randomly assigned in a 1:1 ratio to receive either EED or Comparator. Patients who express a cold sore will track the lesion with a diary card to rate their pain levels, and any unusual symptoms at Day 1, Day 3, Day 5, Day 7, and Day 10. Patients may also take photographs of the lesion throughout the study.

2022-01-20

2024-08-01

2025-01-01

Early phase I

20

Inclusion Criteria To be eligible for enrollment, a subject must meet the following criteria: 1. Understands the requirements of the study and provides written informed consent prior to undergoing any study-related procedures. 2. Subject is a male or female between the ages of 18-65 years old, inclusive. 3. Fitzpatrick skin type II or III. 4. History of at least one year of herpes labialis induced by UV exposure. 5. Able to recall exact location of most common or most recent outbreak. 6. History of at least 50% of cold sore outbreaks occurring with UV (sun) exposure. 7. At least 1 HSV-1 outbreak within the past 12 months. 8. Experiences prodromal symptoms before HSV-1 outbreaks. 9. Subject is willing and able to comply with protocol-specified dosing, visits to the clinic and tracking of pain. Exclusion Criteria Subjects will be excluded from the study if they meet any of the following criteria: 1. Outbreak \<2 weeks prior to enrollment. 2. History of herpes simplex vaccine. 3. On antiviral suppression within the past 30 days. 4. Requires more than acetaminophen for pain from recurrent HSV outbreaks. 5. On any systemic or topical steroid, immune suppressant or chemotherapeutic agent within the past 30 days. 6. Use of tanning beds, history of sunburn, or beach vacation \<2 weeks prior to enrollment. 7. History of photosensitivity, lupus erythematosus, or current use of photosensitizing medication. 8. Current immunosuppressed state due to underlying disease (i.e. HIV infection) concomitant treatment (i.e. chemotherapy). 9. Current upper respiratory tract infection or any active illness that could trigger cold sores or affect overall health of the patient or the assessment of the study agent. 10. Pregnant or intending to become pregnant during the study. 11. Abnormal skin conditions in the area of the recurrent HSV1 outbreaks. 12. Enrolled in another clinical trial within the past 30 days. 13. Previously treated with EED. 14. On any analgesics or NSAIDs that cannot be stopped during the study. 15. Alcohol or drug abuse.

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2023-11-30