Evaluating 2LHERP® for treating recurrent orofacial herpes infections

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

This study is testing if a new treatment called 2LHERP® can help adults with frequent orofacial herpes infections have fewer outbreaks over a year.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 140 (estimated)
• Ages: 16 Years to 80 Years
• Sex: All
• Sponsor: Labo'Life (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 6 sites (Beerzel and 5 other locations)
• Trial ID: NCT04065971 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 16 to 80 with a history of recurrent orofacial herpes infections.

Not a fit: Patients who are pregnant, breastfeeding, or currently undergoing immunotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the frequency of painful herpes outbreaks, improving patients' quality of life.

How similar studies have performed: While 2LHERP® has been used for over 20 years, this specific placebo-controlled trial is novel in its structured evaluation of its efficacy.

Eligibility criteria

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 this trial is running

Beerzel and 5 other locations

• 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

Conditions Herpes Simplex