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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effectiveness of a treatment called 2LHERP for people who experience frequent outbreaks of orofacial herpes, commonly known as cold sores. Orofacial herpes is a condition caused by the herpes simplex virus, leading to painful blisters around the mouth and face. The study aims to see if 2LHERP can reduce the number of herpes outbreaks over a year. The treatment involves taking granules that contain specific nucleic acids, which are tiny building blocks of genetic material, including deoxyribonucleic acid (DNA) and ribonucleic acid (RNA). These granules are designed to be opened and taken by mouth.

Participants in the study will be randomly assigned to receive either the 2LHERP treatment or a placebo, which looks like the treatment but does not contain the active ingredients. This helps researchers understand the true effect of the treatment. The study is conducted in a double-blind manner, meaning neither the participants nor the researchers know who is receiving the actual treatment or the placebo, ensuring unbiased results. The main goal is to evaluate if 2LHERP can decrease the frequency of herpes outbreaks over a 12-month period.

Throughout the study, participants will be monitored for any changes in the number of herpes episodes they experience. Researchers will also observe other factors such as the time it takes for the first recurrence of herpes after starting the treatment, the average duration of each episode, the level of pain during outbreaks, and the overall quality of life. The study will also track any side effects or adverse events that may occur. This research is expected to provide valuable insights into the potential benefits of 2LHERP for managing recurrent orofacial herpes.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient must have experienced 6 or more episodes of orofacial herpes infections in the 12 months prior to the study.

    The patient must be between 16 and 80 years old and, if applicable, use effective contraception.

    The patient must have a stable sexual relationship and be able to understand and comply with the study requirements.

    The patient must sign the informed consent form.

  2. Step 2

    Treatment administration

    The patient will receive either 2LHERP granules or a placebo in pill form.

    The medication is administered through oromucosal use, meaning it is taken by mouth and absorbed through the mucous membranes.

    The treatment aims to evaluate the reduction in the number of herpes episodes over a 12-month period.

  3. Step 3

    Monitoring and evaluation

    The primary goal is to observe any change in the number of herpes episodes over 12 months compared to the baseline period before the study.

    Secondary evaluations include remaining free from herpes recurrence at 6 and 12 months, the number of episodes at 6 months, time to first recurrence, duration of episodes, pain level, use of rescue medication, quality of life, and any adverse events.

  4. Step 4

    Completion of the study

    The study is estimated to conclude by March 31, 2027.

    The final assessment will determine the efficacy of 2LHERP in reducing recurrent herpes episodes.

Who can join the trial?

6 criteria

  • Man or woman aged between 16 and 80 years.
  • Patient has experienced 6 or more episodes of **orofacial herpes** infections in the last 12 months. **Orofacial herpes** refers to cold sores or fever blisters around the mouth or face.
  • If a woman is of childbearing age, she must be using effective birth control.
  • Patient must have a stable sexual relationship, meaning they have a steady sexual partner during the study.
  • Patient must be able to understand and follow the study requirements.
  • Patient must sign the **Informed Consent Form**, which is a document that explains the study and confirms their agreement to participate.

Who cannot join the trial?

1 criterion

  • Patients who have had **recurrent orofacial herpes infections** (6 or more episodes) in the 12 months before the study cannot participate. **Orofacial herpes** refers to cold sores or fever blisters that appear around the mouth or face.
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Investigated drugs

2LHERP® is being studied for its effectiveness in reducing the number of recurrent orofacial herpes episodes over a 12-month period. This medication is being tested to see if it can help people who frequently experience herpes outbreaks on the face or around the mouth.

What is already known about the treatment

2LHERP – This medication is administered orally and is currently being studied in clinical trials to assess its effectiveness in reducing recurrent orofacial herpes infections. It is not yet widely recognized in medical literature as a standard treatment, as it is still under investigation. The main therapeutic indication for 2LHERP is to decrease the frequency of herpes outbreaks in patients who experience six or more episodes within a year. The mechanism of action at the molecular level involves modulating the immune response to prevent viral reactivation. It is classified pharmacologically as an antiviral agent.

Investigated diseases

Recurrent Orofacial Herpes – Recurrent orofacial herpes is a condition characterized by repeated outbreaks of cold sores or fever blisters around the mouth and face. These outbreaks are caused by the herpes simplex virus, which remains dormant in the body and can reactivate under certain conditions such as stress or illness. The initial infection may cause symptoms like blisters, itching, and pain, and subsequent episodes tend to be less severe. The frequency of recurrences can vary, with some individuals experiencing multiple episodes within a year. During an outbreak, small, painful blisters form, which eventually burst and crust over before healing. The condition is contagious, especially when blisters are present.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514358-56-00Estimated enrolment140 patientsSponsorLabo'Life Belgium

sourced from the EU Clinical Trials Register and site verification

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