Evaluating 2LHERP® for treating recurrent orofacial herpes infections

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to assess the efficacy of 2LHERP®, an immune regulator, in reducing the frequency of recurrent orofacial herpes infections in adults. The study will involve 140 participants aged 16 to 80 who have experienced six or more episodes of herpes in the past year. Participants will be randomly assigned to receive either 2LHERP® or a placebo for six months, followed by a six-month follow-up period. The primary objective is to evaluate the reduction in the number of herpes episodes over 12 months, alongside secondary objectives focusing on various aspects of treatment efficacy and safety.

Why it matters

Who can join: the full rules

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.

Where it's running

• Private Practice
  Beerzel, Belgium Recruiting
• Cabinet privé
  Beuzet, Belgium Recruiting
• Clinique Saint-Luc (Bouge)
  Bouge, Belgium Recruiting
• Private Practice
  Linkebeek, Belgium Recruiting
• Cabinet privé
  Noirefontaine, Belgium Recruiting
• Private Practice
  Oisquercq, Belgium Recruiting

Study contacts

• Study coordinator: Laura FERTE
• Email: laura.ferte@labolife.com
• Phone: 499 71 79 64

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.