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

Last updated: October 29, 2024
Sponsor: Labo'Life
Overall Status: Active - Recruiting

Phase

4

Condition

N/A

Treatment

Placebo

2LHERP®

Clinical Study ID

NCT04065971
LLB-2018-01
  • Ages 16-80
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Man or woman aged 16-80 years,

  • Patient presenting 6 or more episodes of orofacial herpes infections during thepreceding 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 duringstudy duration),

  • Patient having faculties to understand and respect the constraints of the study,

  • Signature of the Informed Consent Form.

Exclusion

Exclusion Criteria:

  • Pregnant or breastfeeding woman,

  • Patient under immunotherapy (including immunosuppressive treatment) ormicro-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 12months, or likely to travel or to move before the end of the study,

  • Patient with severe immunodeficiency disease requiring long term treatment (*) orunder 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.

Study Design

Total Participants: 140
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 4
Study Start date:
March 10, 2020
Estimated Completion Date:
March 31, 2027

Study Description

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:

  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.

Connect with a study center

  • Private Practice

    Arlon, 6700
    Belgium

    Site Not Available

  • Private Practice

    Beerzel, 1650
    Belgium

    Active - Recruiting

  • Cabinet privé

    Beuzet, 5030
    Belgium

    Active - Recruiting

  • Clinique Saint-Luc (Bouge)

    Bouge, 5004
    Belgium

    Active - Recruiting

  • Private Practice

    Brussel, 1020
    Belgium

    Site Not Available

  • Private Practice

    Etterbeek, 1040
    Belgium

    Site Not Available

  • Private Practice

    Genval, 1332
    Belgium

    Site Not Available

  • Private practice

    Gozée, 6534
    Belgium

    Site Not Available

  • Cabinet privé

    Hamme-Mille, 1320
    Belgium

    Site Not Available

  • Private Practice

    Kraainem, 1950
    Belgium

    Site Not Available

  • Private practice

    Libramont, 6800
    Belgium

    Site Not Available

  • Vivalia - Centre Hospitalier de L'Ardenne - Libramont Chevigny

    Libramont, 6800
    Belgium

    Terminated

  • Private Practice

    Linkebeek, 1630
    Belgium

    Active - Recruiting

  • Private Practice

    Namur, 5000
    Belgium

    Site Not Available

  • Private practice

    Nivelles, 1400
    Belgium

    Site Not Available

  • Cabinet privé

    Noirefontaine, 6831
    Belgium

    Active - Recruiting

  • Private Practice

    Oisquercq, 1480
    Belgium

    Active - Recruiting

  • Private Practice

    Wavre, 1300
    Belgium

    Site Not Available

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