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EDTA Eye Drops vs. Abreva for Cold Sores
Phase 2
Waitlist Available
Led By Christopher M Hull, M.D.
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject is a male or female between the ages of 18-65 years old, inclusive.
Able to recall exact location of most common or most recent outbreak.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 days per patient
Awards & highlights
Study Summary
This trial will test a new drug to see if it is effective in treating cold sores. The study will last 10 days, and patients will be asked to rate their pain levels and document any unusual symptoms.
Who is the study for?
This trial is for adults aged 18-65 with a history of cold sores from herpes, particularly after UV exposure. They must have had at least one outbreak in the past year and know where they usually occur. Participants need to be able to follow study rules and track their pain levels. People can't join if they're immunosuppressed, recently on antivirals or steroids, pregnant, or have certain skin conditions.Check my eligibility
What is being tested?
The study compares EDTA Eye Drops with Abreva in treating herpes simplex virus eruptions (cold sores). Up to 20 subjects will be randomly assigned to either treatment and will document their symptoms over a period of time using diary cards and possibly photographs.See study design
What are the potential side effects?
While specific side effects are not listed here, participants should report any unusual symptoms during the trial. Common side effects for topical treatments like these could include local irritation, itching, redness or swelling at the application site.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 65 years old.
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I can remember where my last or most common illness outbreak occurred.
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Half of my cold sore outbreaks happen after sun exposure.
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I have had at least one cold sore outbreak in the last year.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 days per patient
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 days per patient
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of subjects using EDTA Eye drops v. those using the Comparator, who do not progress to Stage 3 (vesicle) of a herpes labialis outbreak following UV radiation exposure
Secondary outcome measures
Time of duration of the lesion until healed (loss of hard crust) of patients using EDTA eye drops compared to those using the active comparator.
Side effects data
From 2012 Phase 3 trial • 1708 Patients • NCT0004421315%
Hypocalcaemia
10%
Hypoglycaemia
5%
Proteinuria
4%
Diarrhoea
4%
Nausea
3%
White Blood Cell Count Decreased
100%
80%
60%
40%
20%
0%
Study treatment Arm
EDTA + High Dose Vitamin
EDTA + High Dose Vitamin Placebo
EDTA Placebo + High Dose Vitamin
EDTA Placebo + High Dose Vitamin Placebo
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Study Drug (EDTA Eye Drops)Experimental Treatment1 Intervention
Patients will treat herpes simplex eruption with EDTA eye drops.
Group II: Active Comparator (Abreva)Active Control1 Intervention
Patients will treat herpes simplex eruption with Abreva.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
EDTA
2016
Completed Phase 4
~1960
Find a Location
Who is running the clinical trial?
University of UtahLead Sponsor
1,104 Previous Clinical Trials
1,782,513 Total Patients Enrolled
Christopher M Hull, M.D.Principal InvestigatorUniversity of Utah
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 65 years old.I have had cold sores from sun exposure for at least a year.You have a history of using alcohol or drugs excessively.I haven't used a tanning bed, had a sunburn, or been on a beach vacation in the last 2 weeks.I haven't taken steroids, immune suppressants, or chemotherapy in the last 30 days.I have skin issues where my cold sores usually appear.I feel warning signs before a cold sore outbreak.I am currently immunosuppressed due to a condition like HIV or treatments like chemotherapy.I have been on antiviral medication in the last 30 days.I have been treated with EED before.I can remember where my last or most common illness outbreak occurred.Half of my cold sore outbreaks happen after sun exposure.You have fair or light skin.I have had at least one cold sore outbreak in the last year.I do not have a cold, flu, or any illness that could worsen my health or affect study results.You have received a herpes simplex vaccine in the past.I have a history of sensitivity to sunlight or lupus, or I'm currently using medication that increases my sensitivity to sunlight.I cannot stop taking painkillers or anti-inflammatory drugs for the study.I need stronger medication than acetaminophen for my HSV outbreaks.
Research Study Groups:
This trial has the following groups:- Group 1: Active Comparator (Abreva)
- Group 2: Study Drug (EDTA Eye Drops)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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