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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.
History of at least one year of herpes labialis induced by UV exposure.
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 below
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I am between 18 and 65 years old.
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I have had cold sores from sun exposure for at least a year.
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I feel warning signs before a cold sore outbreak.
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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 weeks
Treatment ~ Varies
Follow Up ~10 days per patient
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 days per patient for reporting.

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 • NCT00044213
15%
Hypocalcaemia
10%
Hypoglycaemia
5%
Proteinuria
4%
Nausea
4%
Diarrhoea
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
1,088 Previous Clinical Trials
1,728,329 Total Patients Enrolled
Christopher M Hull, M.D.Principal InvestigatorUniversity of Utah

Media Library

Abreva (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04893577 — Phase 2
Cold Sores Research Study Groups: Study Drug (EDTA Eye Drops), Active Comparator (Abreva)
Cold Sores Clinical Trial 2023: Abreva Highlights & Side Effects. Trial Name: NCT04893577 — Phase 2
Abreva (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04893577 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are actively engaging in this experiment?

"This clinical trial has ended its recruitment process, having first been advertised on January 20th 2022 and last edited on November 19th 2022. However, there are plenty of other available studies - 28 trials for oral herpes simplex and 1 study involving EDTA are currently enrolling participants."

Answered by AI

Is this scientific experiment welcoming new participants?

"Unfortunately, the specified clinical trial is no longer open to applicants. It was originally posted on January 20th 2022 and had its last update on November 19th 2022. However, there are presently 28 trials for oral herpes simplex that remain available as well as one concerning EDTA which welcomes participants."

Answered by AI

Does this experiment have a maximum age limit for participants?

"The age criterion for this medical experiment requires participants to be between 18 and 65. For those under the legal age limit, there are six trials available; over-65s have access to 24 different studies."

Answered by AI

What adverse effects have been associated with EDTA exposure?

"Despite being a Phase 2 trial with limited data on efficacy, EDTA has been deemed somewhat safe by our team at Power and thus given a score of 2."

Answered by AI

Have any other experiments used EDTA in the past?

"Presently, there is one active clinical trial assessing EDTA's efficacy. This advanced research is not in phase 3 yet and has its primary study site located in Murray, Utah with an additional branch based elsewhere."

Answered by AI

Could I gain admittance to this research project?

"Eligibility criteria for this trial necessitate that patients have oral herpes simplex and are aged between 18 to 65. Approximately 20 people need to be recruited in total."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
University of Utah MidValley Dermatology
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
~3 spots leftby Aug 2024