EDTA Eye Drops Compared to Abreva for Herpes Simplex Virus Eruptions (NCT04893577) | Clinical Trial Compass
CompletedPhase 2
EDTA Eye Drops Compared to Abreva for Herpes Simplex Virus Eruptions
United States10 participantsStarted 2022-01-20
Plain-language 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 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion 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.
Exclusion criteria
✕. Outbreak \<2 weeks prior to enrollment.
✕. History of herpes simplex vaccine.
What they're measuring
1
Duration (Days) of Herpes Labialis Outbreak Until Healed