At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating EDTA and Abreva for Herpes Simplex Oral. Completed, enrolled 10 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Patients will treat their cold sore with EDTA eye drops based upon their randomization.
Patients will treat their cold sore with Abreva based upon their randomization