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.