Ongoing Clinical Trials for Oral Herpes

There are currently 2 clinical trials investigating new treatments for oral herpes, a viral infection that causes cold sores around the mouth. These studies are taking place in Poland and Belgium, testing different approaches to reduce the frequency and severity of outbreaks. One trial compares traditional antiviral medications, while the other explores a novel treatment aimed at preventing recurrent episodes.

Clinical trial locations

• Belgium
  • Study on the Effectiveness of 2LHERP in Reducing Recurrent Cold Sores in Patients with Frequent Outbreaks
• Poland
  • Study comparing aciclovir gel and cream effectiveness in treating recurrent cold sores (herpes labialis)

Study comparing aciclovir gel and cream effectiveness in treating recurrent cold sores (herpes labialis)

This study, conducted in Poland, examines two different forms of aciclovir medication for treating cold sores. The trial compares Lipovir gel and Zovirax cream, both containing 5% aciclovir, against a placebo to determine if the gel formulation works as well as the cream in treating outbreaks.

Main inclusion criteria:

• Must be at least 18 years old
• Must have experienced at least 3 cold sore episodes in the past year
• At least half of these outbreaks must be preceded by early warning signs such as itching, redness, burning, tingling, or irritation
• At least half of these warning signs must develop into typical cold sore symptoms like ulcers, fluid-filled blisters, or hard crusts
• Must be able to understand and follow study procedures, including keeping a daily diary

Main exclusion criteria:

• History of allergic reactions to aciclovir or similar medications
• Pregnancy or breastfeeding
• Current participation in other clinical trials
• Use of antiviral medications in the past 14 days
• Weakened immune system due to medications or medical conditions
• Other skin conditions in the area affected by cold sores
• Active cold sore present for more than 48 hours
• Use of topical treatments on the affected area in the past 24 hours

Study focus: The trial aims to measure how long it takes for cold sores to heal completely when treated with either gel or cream formulation. Participants apply their assigned treatment at the first sign of an outbreak and continue for up to 10 days. They keep track of their healing progress in a daily diary. The main focus is comparing the healing time from when treatment begins until the skin returns to normal or symptoms stop.

Investigational drugs: The study tests two forms of aciclovir. Lipovir Gel is a topical medication containing 5% aciclovir in gel formulation. Zovirax Cream is a well-established cream also containing 5% aciclovir. Both medications work by stopping the herpes virus from multiplying, helping to reduce the duration and severity of cold sore outbreaks. The difference lies in their formulation—one is a gel and the other a cream—though they contain the same amount of active ingredient.

Study on the Effectiveness of 2LHERP in Reducing Recurrent Cold Sores in Patients with Frequent Outbreaks

This Belgian trial investigates a new treatment called 2LHERP for people who experience frequent cold sore outbreaks. The study aims to determine if this treatment can reduce the number of outbreaks over a year-long period. The medication comes in granule form that is taken by mouth and absorbed through the mucous membranes.

Main inclusion criteria:

• Must be between 16 and 80 years old
• Must have experienced 6 or more cold sore episodes in the 12 months before joining the study
• If a woman of childbearing age, must be using effective birth control
• Must have a stable sexual relationship with a steady partner
• Must be able to understand and follow study requirements
• Must sign an informed consent form

Main exclusion criteria:

• Cannot participate if you have already had 6 or more episodes of cold sores in the 12 months before the study, as this is actually an inclusion requirement

Study focus: The primary goal is to evaluate whether 2LHERP can decrease the frequency of cold sore episodes over 12 months compared to the baseline period before treatment. The study will also monitor several other important factors including whether participants remain free from outbreaks at 6 and 12 months, how long until the first recurrence happens, the duration of each episode, pain levels during outbreaks, use of additional medications, quality of life, and any side effects. This is a double-blind study, meaning neither participants nor researchers know who receives the actual treatment or placebo, ensuring unbiased results.

Investigational drug: 2LHERP contains specific nucleic acids, which are tiny building blocks of genetic material including DNA and RNA. The granules are opened and taken by mouth. The treatment is being investigated for its ability to reduce the number of recurrent cold sore episodes by modulating the immune response to prevent the virus from reactivating. It is classified as an antiviral agent, though it is still under investigation and not yet a standard treatment. The study is expected to conclude by March 31, 2027.

Summary

The two ongoing clinical trials for oral herpes represent different approaches to managing this common condition. The Polish study focuses on comparing existing aciclovir treatments in different formulations, aiming to determine whether a gel or cream works better for treating active outbreaks. This trial targets people with moderate recurrence rates of at least 3 episodes per year.

The Belgian study takes a different approach by testing a novel medication designed to prevent outbreaks altogether in people who experience frequent recurrences. This trial requires participants to have had 6 or more episodes in the past year, indicating it targets those with more severe, recurring cases.

Both studies use rigorous scientific methods including placebo controls to ensure reliable results. The geographic distribution shows research activity in Central and Western Europe, with each country hosting one trial. The Polish study focuses on immediate outbreak treatment with short-term monitoring, while the Belgian study takes a longer-term prevention approach with 12-month follow-up. Together, these trials address both the acute treatment needs and long-term prevention strategies for people living with recurrent cold sores.