Actively Recruiting

Phase 4
Age: 16Years - 80Years
All Genders
NCT04065971

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

Led by Labo'Life · Updated on 2024-10-31

140

Participants Needed

6

Research Sites

368 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 16Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Man or woman aged 16-80 years
  • Having 6 or more episodes of orofacial herpes infections in the 12 months before joining the study
  • Woman of childbearing age under effective contraception
  • In a stable sexual relationship during the study period
  • Able to understand and follow study requirements
  • Signed the informed consent form
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding women
  • Receiving immunotherapy or micro-immunotherapy in the past 6 months
  • Had suppressive antiviral therapy in the past month
  • Intending to continue suppressive antiviral therapy
  • Known lactose intolerance
  • Participated in another clinical study in the past 3 months
  • Not motivated for 12 months of follow-up or likely to travel/move before study ends
  • Severe immunodeficiency requiring long-term treatment, chemotherapy, radiotherapy, or corticoid therapy
  • Using listed homeopathic or phytotherapy treatments
  • Using or addicted to recreational drugs

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 6 locations

1

Private Practice

Beerzel, Belgium, 1650

Actively Recruiting

2

Cabinet privé

Beuzet, Belgium, 5030

Actively Recruiting

3

Clinique Saint-Luc (Bouge)

Bouge, Belgium, 5004

Actively Recruiting

4

Private Practice

Linkebeek, Belgium, 1630

Actively Recruiting

5

Cabinet privé

Noirefontaine, Belgium, 6831

Actively Recruiting

6

Private Practice

Oisquercq, Belgium, 1480

Actively Recruiting

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Research Team

L

Laura FERTE

CONTACT

C

Charlotte BOLLE

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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