Randomized, Placebo-controlled, Double Blind Study to Evaluate the Efficacy of 2LVERU®JUNIOR and 2LVERU® on the Treatment of Warts

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

Phase

4

Condition

Warts

Treatment

2LVERU® or 2LVERU® JUNIOR

Placebo

Clinical Study ID

NCT03977753
LLB-2019-02
  • Ages > 3
  • All Genders

Study Summary

Human papillomavirus (HPV) infection is very common, as most people will experience infection during their lifetime. The most common manifestation of HPV infection is common warts. Common warts may appear at any age.

Conventional treatments can be used to treat warts and they are based on two mechanisms: stimulation of cellular immunity against HPVs or destruction of the lesion. These treatments are based on the location of the wart and the degree of the symptoms.

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

The 2LVERU® has been available for more than 20 years, and has received a marketing authorization in Belgium by the Federal Agency for Medicines and Health Products (FAMHP). It is used as an immune regulator in the treatment of common warts (verruca vulgaris), flat warts (verruca plana) or plantar warts (verruca plantaris) caused by Human Papillomavirus. Since 2LVERU® has been made available, clinical observational data collected on treated patients have shown the beneficial effect on the disappearance of warts.

The purpose of this placebo-controlled, randomized, double-blind trial is the comparison of the efficacy of the treatment on the disappearance of warts at the end of treatment (6-month visit) between the 2LVERU® JUNIOR and 2LVERU® versus the placebo group.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients, male or female, aged 3 years and older,

  • Patients with common warts (Verruca vulgaris), and/or plantar warts (Verrucaplantaris), and/or flat warts (Verruca plana),

  • Patients (and/or parents if necessary) having the faculties to understand andrespect the constraints of the study,

  • Signature of the Informed Consent Form by the patient (and/or parents if necessary).

Exclusion

Exclusion Criteria:

  • Patients who have received any curative warts treatment in the previous 2 monthsprior to the study,

  • Patients who have received any homeopathic treatment in the previous 2 months priorto the study,

  • Patients under immunosuppressive treatment,

  • Patients having received immunotherapy or micro-immunotherapy during the last 6months,

  • Patients with known lactose intolerance,

  • Pregnant or breastfeeding women,

  • Patients who participated in a clinical study in the previous 2-months period,

  • Patients (and/or parents of patients if necessary) who are not sufficientlymotivated to engage on the total study follow-up period, or likely to travel or tomove before the end of the study,

  • Patients with severe immunodeficiency disease requiring long term treatment (*) orpatients under chemotherapy or radiotherapy,

  • Patients under listed homeopathic or phytotherapy treatment (see protocol),

  • Patients addicted to or using recreational drugs,

  • Patient under guardianship and/or curators, (*) important renal or respiratoryinsufficiency, transplanted or grafted patients, HIV/AIDS, terminal cancer.

Study Design

Total Participants: 162
Treatment Group(s): 2
Primary Treatment: 2LVERU® or 2LVERU® JUNIOR
Phase: 4
Study Start date:
February 17, 2020
Estimated Completion Date:
March 16, 2027

Study Description

The study duration will be maximum 45 months with 36 months of inclusion and 9 months of follow-up.

Patients aged 3 years and older who present common warts (Verruca vulgaris), and/or plantar warts (Verruca plantaris), and/or flat warts (Verruca plana) during a visit with their dermatologist/general practitioner.

The total number of patients to include will be 162.

Primary objective:

Comparison of the efficacy of the treatment on the disappearance of warts at the end of treatment (6-month visit) between the 2LVERU® JUNIOR and 2LVERU® versus the placebo group.

Secondary objectives

  • Comparison of the efficacy of the treatment on the disappearance of warts at 4 months between groups.

  • Comparison of the efficacy of the treatment on the level of disappearance (4 levels) of warts at 4 months and 6 months (end of the treatment) between groups

  • Comparison of the efficacy of the treatment on the recurrence of warts 3 months after the end of treatment between groups

  • Compare the pain related to warts during the study between groups

  • Safety issues.

Treatment phase:

  • Group n°1 = 2LVERU® JUNIOR / 2LVERU® (6 months of treatment)

  • Group n°2 = Placebo (6 months of treatment)

Post-treatment Follow-up phase: 3 months

Treatment will be considered successful if the following three criteria are met for all treated warts as described at the baseline visit:

  • Normal skin colour at the wart site

  • Normal skin texture at the wart site

  • Normal touch at the wart site Treatment will be considered a failure, at the end of the treatment, if at least one of the above three criteria is not met for all treated warts as described at the baseline visit.

Connect with a study center

  • Private Practice

    Arlon, 6700
    Belgium

    Site Not Available

  • Clinique Saint-Luc (Bouge)

    Bouge, 5004
    Belgium

    Active - Recruiting

  • Private Practice

    Brussel, 1020
    Belgium

    Terminated

  • Grand Hopital de Charleroi - Site Notre Dame

    Charleroi, 6000
    Belgium

    Site Not Available

  • Private Practice

    Ecaussinnes-d'enghien, 7190
    Belgium

    Terminated

  • Private Practice

    Fontaine l'Êveque, 6140
    Belgium

    Suspended

  • Private Practice

    Gent, 9942
    Belgium

    Active - Recruiting

  • Private Practice

    Genval, 1332
    Belgium

    Site Not Available

  • Private Practice

    Gozée, 6534
    Belgium

    Terminated

  • Private Practice

    Hamme-Mille, 1320
    Belgium

    Active - Recruiting

  • Private Practice

    Juprelle, 4450
    Belgium

    Site Not Available

  • Grand Hôpital de Charleroi

    Loverval, 6280
    Belgium

    Site Not Available

  • Private Practice

    Mons, 7000
    Belgium

    Site Not Available

  • Private Practice

    Namur, 5000
    Belgium

    Active - Recruiting

  • Private Practice

    Oisquercq, 1480
    Belgium

    Terminated

  • Centre Médical de Perwez

    Perwez, 1360
    Belgium

    Site Not Available

  • Private Practice

    Plancenoit, 1380
    Belgium

    Site Not Available

  • Private Practice

    Quiévrain, 7380
    Belgium

    Site Not Available

  • Private Practice

    Saint-Symphorien, 7030
    Belgium

    Active - Recruiting

  • Private Practice

    Seneffe, 7180
    Belgium

    Active - Recruiting

  • Private Practice

    Uccle, 1180
    Belgium

    Site Not Available

  • Private Practice

    Wavre, 1300
    Belgium

    Active - Recruiting

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