EDTA Eye Drops vs. Abreva for Cold Sores

Overseen By Adrianne D Evans, CCRC

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Utah

Must not be taking: Steroids, Immunosuppressants, Chemotherapy, NSAIDs

Disqualifiers: Recent outbreak, Immunosuppressed, Photosensitivity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: 7 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two treatments for cold sores, which are blisters caused by the herpes simplex virus. Researchers aim to determine if EDTA eye drops, a potential new treatment, can match the effectiveness of Abreva, a cream already used for cold sores. Participants will use either the eye drops or the cream to treat their cold sores and will monitor their symptoms. The trial seeks individuals who have experienced cold sores triggered by sunlight for at least a year and have had at least one outbreak in the past year. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop taking my current medications to join the trial?

The trial requires that you stop taking any antiviral medications, steroids, immune suppressants, chemotherapeutic agents, and certain pain relievers like NSAIDs at least 30 days before joining. If you are on these medications, you will need to stop them to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research on EDTA eye drops for cold sores has not yet provided much specific safety data. However, since this trial is in Phase 2, the treatment has already undergone safety testing in humans. This indicates that EDTA eye drops are considered safe enough for further testing, though more information is needed for confirmation.

Abreva, a well-known treatment for cold sores, has already received FDA approval, indicating its general safety for use. While minor side effects may occur, they are typically mild and uncommon.

In summary, both treatments in this trial have some safety support. EDTA eye drops are still under safety evaluation, while Abreva has a well-established safety record. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for cold sores?

EDTA eye drops are unique because they utilize a different active ingredient than standard cold sore treatments like Abreva, which typically contain docosanol. While most treatments work by blocking the virus from entering healthy cells, EDTA, an agent known for chelating metals, may offer a novel mechanism by potentially disrupting viral replication. Researchers are excited about EDTA eye drops because they could provide a faster or more effective way to reduce the duration and severity of cold sores.

What evidence suggests that this trial's treatments could be effective for cold sores?

Research has shown that EDTA Eye Drops, one of the treatments in this trial, might help treat cold sores by reducing calcium levels, which can prevent the virus from spreading. In contrast, Abreva, the active comparator in this trial, is already known to effectively treat cold sores by stopping the virus from entering healthy skin cells. This study will compare EDTA Eye Drops to Abreva to determine which heals cold sores faster. While Abreva's effectiveness is well-established, the potential of EDTA Eye Drops remains under investigation. Early results from similar treatments suggest that EDTA might be effective, but further research is needed to confirm this. ^{1 2 3 6 7}

Who Is on the Research Team?

Christopher M Hull, M.D.

Principal Investigator

University of Utah

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have had cold sores from sun exposure for at least a year.

I feel warning signs before a cold sore outbreak.

I can remember where my last or most common illness outbreak occurred.

Exclusion Criteria

Pregnant or intending to become pregnant during the study.

Enrolled in another clinical trial within the past 30 days.

You have a history of using alcohol or drugs excessively.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Treatment

Participants receive either EDTA Eye Drops or Abreva, applied 5 times daily for up to 7 days following UV radiation exposure

7 days

Daily self-administration, with virtual follow-ups on Days 3, 4, 5, 6, and 7

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments on Day 10 and an end of study visit

3 days

1 visit (in-person) on Day 10, 1 end of study visit

What Are the Treatments Tested in This Trial?

Interventions

• Abreva
• EDTA Eye Drops

Trial Overview

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.

How Is the Trial Designed?

Group I: Study Drug (EDTA Eye Drops) Experimental Treatment 1 Intervention

Patients will treat herpes simplex eruption with EDTA eye drops.

Group II: Active Comparator (Abreva) Active Control 1 Intervention

Patients will treat herpes simplex eruption with Abreva.

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04893577

EDTA Eye Drops Compared to Abreva for Herpes Simplex ...

Patients will treat herpes simplex eruption with EDTA eye drops. Patients will treat their cold sore with EDTA eye drops based upon their randomization.

2.

withpower.com

withpower.com/trial/phase-3-stomatitis-herpetic-7-2021-3f532

EDTA Eye Drops vs. Abreva for Cold Sores

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, ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7220348/

Treatment of herpes labialis by photodynamic therapy

It is known that antimicrobial photodynamic therapy (aPDT) has numerous advantages, among them: the reduction of the time of remission, and does not cause ...

4.

aging.networkofcare.org

aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials?keyword=%22Herpes%20Simplex%20Oral%22

San Mateo Clinical Trials

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 ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3472024/

Comparison of Two OTC Drugs and Untreated Controls

Rapid resolution of active herpes labialis lesions is of great benefit to the patient not only in terms of controlling pain and disfigurement, but in disruption ...

6.

mdpi.com

mdpi.com/1422-0067/24/16/12657

Instantaneous Inactivation of Herpes Simplex Virus by ...

Si3N4 is a non-oxide ceramic compound with strong antibacterial and antiviral properties that has been proven safe for human cells. HSV-1 is a double-stranded ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6461191/

Interventions for prevention of herpes simplex labialis (cold ...

There were no consistent data to confirm that levamisole and interferon do prevent cold sores. These studies found no increase in adverse events related to the ...