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:

• number of episodes at 6 months,
• time to first episode during the treatment,
• duration of episodes,
• symptomatology during the entire relapse time,
• use of Rescue Medication (RM),
• evaluation of impact on the quality of life,
• 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.

Inclusion criteria

• Man or woman aged 16-80 years,
• Patient presenting 6 or more episodes of orofacial herpes infections during the preceding 12-months' period (prior to the study entry),
• Woman of childbearing age under effective contraception,
• Patient reporting a current stable sexual relationship (steady sexual partner during study duration),
• Patient having faculties to understand and respect the constraints of the study,
• Signature of the Informed Consent Form.

Exclusion criteria

• Pregnant or breastfeeding woman,
• Patient under immunotherapy (including immunosuppressive treatment) or micro-immunotherapy received during last previous 6 months,
• Patient who had a suppressive antiviral therapy during last month,
• Patient who wishes to continue his/her suppressive antiviral therapy,
• Patient with known lactose intolerance,
• Patient who participated in a clinical study in the previous 3-month period,
• Patient who is not sufficiently motivated to engage in a follow-up period of 12 months, or likely to travel or to move before the end of the study,
• Patient with severe immunodeficiency disease requiring long term treatment (*) or under chemotherapy or radiotherapy or corticoid therapy,
• Patient under listed homeopathic or phytotherapy treatment,
• Patient using or addicted to recreational drugs.

(*) important renal or respiratory insufficiency, transplanted or grafted patients HIV/AIDS, terminal cancer.