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;

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

Study Summary

This trial is being done to study the efficacy of acyclovir 50mg buccal tablet in the treatment of recurrent herpes labialis, also known as cold sores. Acyclovir is a medication used to treat viral infections and the tablet form sticks to the inside of the mouth to directly treat the infected area. The study will compare the duration of the episode for those taking acyclovir 50mg buccal tablet to those taking a placebo. There will be 2 weeks of treatment and a 12 month follow up phase with virtual meetings from home using the internet.

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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Duration of episode (DOE) will be measured in hours (using the Science 37 Platform), of a single treated HL lesion

Secondary outcome measures

Incidence of Treatment-Emergent Adverse Events

Incidence of aborted lesions

Incidence of recurrence of HL lesions during the 12-month follow-up period

+2 more

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

0 / 4Eligibility 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.