Status:
COMPLETED
EDTA Eye Drops Compared to Abreva for Herpes Simplex Virus Eruptions
Lead Sponsor:
University of Utah
Conditions:
Herpes Simplex Oral
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
1.1 Background and Rationale Herpes simplex virus (HSV) infections are common and can cause significant morbidity both at the time of the original infection and when recurrences occur. There are two t...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- To be eligible for enrollment, a subject must meet the following criteria:
- Understands the requirements of the study and provides written informed consent prior to undergoing any study-related procedures.
- Subject is a male or female between the ages of 18-65 years old, inclusive.
- Fitzpatrick skin type II or III.
- History of at least one year of herpes labialis induced by UV exposure.
- Able to recall exact location of most common or most recent outbreak.
- History of at least 50% of cold sore outbreaks occurring with UV (sun) exposure.
- At least 1 HSV-1 outbreak within the past 12 months.
- Experiences prodromal symptoms before HSV-1 outbreaks.
- 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:
- Outbreak \<2 weeks prior to enrollment.
- History of herpes simplex vaccine.
- On antiviral suppression within the past 30 days.
- Requires more than acetaminophen for pain from recurrent HSV outbreaks.
- On any systemic or topical steroid, immune suppressant or chemotherapeutic agent within the past 30 days.
- Use of tanning beds, history of sunburn, or beach vacation \<2 weeks prior to enrollment.
- History of photosensitivity, lupus erythematosus, or current use of photosensitizing medication.
- Current immunosuppressed state due to underlying disease (i.e. HIV infection) concomitant treatment (i.e. chemotherapy).
- 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.
- Pregnant or intending to become pregnant during the study.
- Abnormal skin conditions in the area of the recurrent HSV1 outbreaks.
- Enrolled in another clinical trial within the past 30 days.
- Previously treated with EED.
- On any analgesics or NSAIDs that cannot be stopped during the study.
- Alcohol or drug abuse.
Exclusion
Key Trial Info
Start Date :
January 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04893577
Start Date
January 20 2022
End Date
August 1 2025
Last Update
October 31 2025
Active Locations (1)
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1
University of Utah MidValley Dermatology
Murray, Utah, United States, 84107