Bouillon

Herpes simplex virus (HSV) infections are very common and often cause sores that can appear at any age. There is currently no specific antiviral treatment that completely cures or eradicates the virus. This study evaluates the effectiveness of 2LHERP4, an immune regulator authorized in Belgium, in reducing recurrent orofacial herpes episodes in adults with frequent outbreaks. The study is a phase 4, placebo-controlled trial designed to assess 2LHERP4 compared to a placebo. Participants will be randomly assigned to one of two groups: one receiving 2LHERP4 capsules and the other receiving placebo capsules. Both groups will take one capsule daily, 15-30 minutes before breakfast on an empty stomach, following a sequential order of capsules numbered 1 through 10 repeatedly for a total of 6 months of continuous treatment. After the treatment phase, participants will be followed for an additional 6 months without treatment. During the study, researchers will monitor the number of herpes episodes over 12 months, time to the first episode, episode duration, symptoms, use of rescue medication, quality of life impact, and safety. Participants will be assessed through clinical observations and questionnaires over the 12-month follow-up. The total study duration is 36 months, including 24 months for enrolling participants and 12 months of follow-up for each patient.