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

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  • sponsor
Updated on 26 April 2022
antiviral agents
herpes infection


Herpes simplex virus (HSV) infection is very common, as most people will experience herpetic infection during their lifetime. The most common manifestation of HSV infection is sores which may appear at any age.

No specific antiviral therapy is available to totally cure herpetic infections and today, there is no treatment that allows the definitive eradication of the virus.

The 2LHERP® has been available for more than 20 years, and has received a marketing authorization in Belgium by the FAMHP. It is used as an immune regulator in the treatment of herpetic infections. Since 2LHERP® has been made available, clinical observational data collected on treated patients have shown the beneficial effect on the disappearance of herpetic recurrences.

The purpose of this placebo-controlled trial is to evaluate the efficacy of 2LHERP® on the treatment of herpetic infections in adults.


The study duration will be maximum 24 months with 12 months of inclusion and 12 months of follow-up.

Patients aged between 18 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.

Condition Herpes Simplex
Treatment Placebo, 2LHERP®
Clinical Study IdentifierNCT04065971
Last Modified on26 April 2022


Yes No Not Sure

Inclusion Criteria

Man or woman aged 18-80 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
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