EDTA Eye Drops Compared to Abreva for Herpes Simplex Virus Eruptions
Not yet recruiting
University of Utah
Phase 2
2021-11-01
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.
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