What is the mechanism of action of this treatment?

Common treatments for cold sores, such as antiviral medications like acyclovir, work by inhibiting the replication of the herpes simplex virus (HSV) within the cells, thereby reducing the duration and severity of outbreaks. Topical treatments like Abreva (docosanol) prevent the virus from entering healthy cells, which helps to limit the spread of infection. EDTA eye drops, a chelating agent, are being studied for their potential to bind metal ions, which may disrupt viral replication or reduce inflammation. This is significant for cold sore patients as it offers a different mechanism of action that could be used in combination with existing treatments to enhance overall effectiveness and provide better symptom control.

What side effects are associated with this type of intervention?

Common treatments for cold sores include antiviral medications like acyclovir, valacyclovir, and famciclovir, as well as topical treatments such as docosanol (Abreva). Side effects of antiviral medications can include headache, nausea, and diarrhea. Topical treatments may cause mild skin irritation or allergic reactions. For chelating agents like EDTA, potential side effects could include local irritation, redness, or discomfort at the application site. It is important to consult with a healthcare provider to determine the most appropriate treatment and manage any side effects.

What prior FDA approvals exist?

FDA-approved treatments for cold sores primarily include antiviral medications such as acyclovir, valacyclovir, and famciclovir, which inhibit viral replication. Topical treatments like docosanol (Abreva) are also approved and work by preventing the virus from entering cells. While EDTA Eye Drops are being studied for their potential to disrupt viral replication or reduce inflammation through chelation, there are no current FDA-approved chelating agents specifically for cold sores. The focus remains on antiviral agents that directly target the herpes simplex virus.

What other types of research exist?

Promising, novel alternatives to EDTA Eye Drops for cold sores include: 1) PDSTP gel, which has shown significant efficacy in reducing corneal lesions in herpes simplex epithelial keratitis, suggesting potential for broader HSV applications. 2) Oral valaciclovir, which has been effective in treating herpetic keratitis and could be a convenient systemic option for cold sores. 3) Abreva (docosanol), a topical treatment that is already established for cold sores and works by inhibiting the fusion of the herpes virus with the host cell membrane.

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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.

Must not have

Abnormal skin conditions in the area of the recurrent HSV1 outbreaks.

Current immunosuppressed state due to underlying disease (i.e. HIV infection) concomitant treatment (i.e. chemotherapy).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 days per patient

Awards & highlights

No Placebo-Only Group

Summary

This trial tests EDTA Eye Drops and Abreva on patients with recurring cold sores. EDTA Eye Drops aim to stop the virus by reducing calcium levels, while Abreva blocks the virus from infecting skin cells. The goal is to find better treatments for cold sore outbreaks.

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.

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.

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 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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have skin issues where my cold sores usually appear.

Select...

I am currently immunosuppressed due to a condition like HIV or treatments like chemotherapy.

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I have been treated with EED before.

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I have a history of sensitivity to sunlight or lupus, or I'm currently using medication that increases my sensitivity to sunlight.

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I cannot stop taking painkillers or anti-inflammatory drugs for the study.

Select...

I need stronger medication than acetaminophen for my HSV outbreaks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 days per patient

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Proteinuria

Nausea

Diarrhoea

White Blood Cell Count Decreased

100%

80%

60%

40%

20%

Study treatment Arm

EDTA + High Dose Vitamin

EDTA + High Dose Vitamin Placebo

EDTA Placebo + High Dose Vitamin

EDTA Placebo + High Dose Vitamin Placebo

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for cold sores, such as antiviral medications like acyclovir, work by inhibiting the replication of the herpes simplex virus (HSV) within the cells, thereby reducing the duration and severity of outbreaks. Topical treatments like Abreva (docosanol) prevent the virus from entering healthy cells, which helps to limit the spread of infection. EDTA eye drops, a chelating agent, are being studied for their potential to bind metal ions, which may disrupt viral replication or reduce inflammation. This is significant for cold sore patients as it offers a different mechanism of action that could be used in combination with existing treatments to enhance overall effectiveness and provide better symptom control.

Antiviral activity of metal chelates of caffeic acid and similar compounds towards herpes simplex, VSV-Ebola pseudotyped and vaccinia viruses.Results of treatment of Wilson's disease--own observations.[Preparation and antiinflammatory activity of selected aqua-(aryloxyacetate) zinc complexes].