What side effects are associated with this type of intervention?

Common treatments for cold sores, such as acyclovir, valacyclovir, and famciclovir, are generally well-tolerated but can have side effects. These may include headache, nausea, diarrhea, and in some cases, more severe reactions like renal dysfunction or neurotoxicity, particularly in higher doses or in patients with pre-existing conditions. Topical formulations may cause local irritation or burning at the application site. It is important to discuss these potential side effects with a healthcare provider to determine the most appropriate treatment.

What prior FDA approvals exist?

The FDA has approved several antiviral medications for the treatment of cold sores (herpes labialis), which work by inhibiting HSV replication. These include Acyclovir, Valacyclovir, and Famciclovir. Acyclovir, available in topical, oral, and buccal tablet forms, was one of the first antiviral drugs approved for this purpose. Valacyclovir, a prodrug of Acyclovir, offers improved bioavailability and is commonly prescribed for its convenience in dosing. Famciclovir, another oral antiviral, is also used for its efficacy in reducing the duration and severity of cold sore outbreaks.

What other types of research exist?

Promising novel alternatives to Acyclovir 50 mg buccal tablet for cold sores include Valacyclovir and Famciclovir. Valacyclovir, which can be administered in shorter treatment courses, and Famciclovir, which has shown efficacy in single-day treatment regimens, are both effective in inhibiting HSV replication and may offer more convenient dosing options.

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Antiviral

Acyclovir for Cold Sores

Phase 3

Waitlist Available

Research Sponsored by Bayer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Agreement to abstain from any mechanical disruption of the prodromal area or lesion

Recurrence is defined as at least 4 episodes in the preceding 12 months;

Must not have

Allergy to any acyclovir or its containing agents

Self-reported immunocompromised condition, including self-reported Human Immunodeficiency Virus (HIV) positive and previous bone marrow or organ transplant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Pivotal Trial

Summary

This trial is testing a small tablet that sticks to the gum and releases medicine to treat cold sores. It targets people who frequently get cold sores. The medicine works by stopping the virus from multiplying and spreading, which helps heal the sores faster.

Who is the study for?

Adults 18+ with frequent cold sores (at least 4 episodes in the past year) can join this trial. Participants must not disturb their cold sore lesions, be willing to avoid certain medications and treatments that affect immune response, and follow study instructions. Women of childbearing age need effective birth control and a negative pregnancy test.

What is being tested?

The trial is testing if a buccal tablet containing Acyclovir (50mg), which sticks to the gum inside the mouth, is more effective than a placebo at treating herpes labialis. The main focus is on how quickly symptoms disappear after treatment over a period of up to 20 months with virtual check-ins.

What are the potential side effects?

Possible side effects include allergic reactions for those sensitive to acyclovir or its components, though specific side effects are not listed; all medical problems during the study will be tracked as adverse events.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I agree not to disturb the area where my disease might start or has started.

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I have had at least 4 episodes of my condition in the last year.

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My Hodgkin's lymphoma has come back after treatment.

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I am able to understand and sign the consent form.

Exclusion Criteria

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

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I am allergic to acyclovir or similar medications.

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I have a condition that weakens my immune system, such as HIV or a past transplant.

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My primary herpes sore is not on my lips.

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I am pregnant, breastfeeding, or planning to become pregnant.

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I have a history of severe kidney disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Acyclovir 50mg buccal/topical tablet treatment groupExperimental Treatment1 Intervention

Group II: Matching placebo groupPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Acyclovir 50mg buccal/topical tablet, BAYM008894/UI1614773

2021

Completed Phase 3

~2020

0 / 9Eligibility 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

Acyclovir, a common treatment for cold sores, works by inhibiting the replication of the herpes simplex virus (HSV). It is converted into its active form within infected cells, where it interferes with viral DNA synthesis, preventing the virus from multiplying and spreading. This mechanism is crucial for cold sore patients as it reduces the duration and severity of outbreaks, promotes faster healing of lesions, and can potentially decrease the frequency of recurrences.

Long-term acyclovir suppression of frequently recurring genital herpes simplex virus infection. A multicenter double-blind trial.