Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy of 2LHERP® in Patients With Recurrent Orofacial Herpes Infections

What this Trial Is About

Herpes simplex virus (HSV) infection is very common and often causes sores at any age. There is currently no treatment that completely cures or eradicates the virus. This trial evaluates the efficacy of 2LHERP®, an immune regulator used for over 20 years in treating herpetic infections, in adults with recurrent orofacial herpes infections. The study is placebo-controlled and aims to assess 2LHERP®'s impact on reducing herpes recurrences. The study will last 36 months, including 24 months for patient enrollment and 12 months of follow-up. Participants aged 16 to 80 with at least six episodes of orofacial herpes in the past year will be randomly assigned to receive either 2LHERP® or a placebo for 6 months. Both treatments involve taking one capsule daily, 15-30 minutes before breakfast on an empty stomach, following a sequential capsule order. After the treatment phase, participants will be followed for an additional 6 months. During the trial, participants will be monitored for the number of herpes episodes, time to first recurrence, episode duration, symptom severity, use of rescue medication, and quality of life. Safety will also be assessed through adverse event reporting. The primary outcome is the reduction in recurrent herpes episodes at 12 months. Participants will complete daily diaries and questionnaires, with regular evaluations throughout treatment and follow-up.

Randomized, Placebo-controlled, Double-blind Study of 2LHERP® in Orofacial Herpes Infections.