Nilphamari, Bangladesh

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

The study duration will be 36 months with 24 months of inclusion (that may be extended if the expected number of patients is not reached after this period) and 12 months of follow-up. Patients aged between 16 and 80 years who present recurrent orofacial herpes infections (6 or more episodes within the 12-months' period prior to their study entry). The total number of patients to include will be 140 with 70 patients per group. Primary objective: Evaluation of the efficacy of 2LHERP® on the reduction of the number of recurrent orofacial herpes episodes at 12 months. Secondary objectives: Comparison of the efficacy of 2LHERP® vs placebo according to the following aspects: 1. number of episodes at 6 months, 2. time to first episode during the treatment, 3. duration of episodes, 4. symptomatology during the entire relapse time, 5. use of Rescue Medication (RM), 6. evaluation of impact on the quality of life, 7. safety issues. Treatment phase: - Group n°1 = 2LHERP® (6 months of treatment) - Group n°2 = Placebo (6 months of treatment) Post-treatment follow-up phase: 6 months. Treatment will be considered successful if the number of herpetic episodes is reduced.