Actively Recruiting

Phase 4
Age: 3Years +
All Genders
NCT03977753

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

Led by Labo'Life · Updated on 2024-10-30

162

Participants Needed

18

Research Sites

369 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 3Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 3 years and older
  • Patients with common warts, plantar warts, or flat warts
  • Patients (or their parents) able to understand and follow study requirements
  • Signed informed consent by the patient or parent/guardian
Not Eligible

You will not qualify if you...

  • Patients treated for warts in the previous 2 months
  • Patients who had homeopathic treatment in the previous 2 months
  • Patients on immunosuppressive treatment
  • Patients who had immunotherapy or micro-immunotherapy in the last 6 months
  • Patients with known lactose intolerance
  • Pregnant or breastfeeding women
  • Patients who participated in another clinical study in the last 2 months
  • Patients or parents not motivated to complete the study or likely to move/travel before study ends
  • Patients with severe immunodeficiency needing long-term treatment, chemotherapy, or radiotherapy
  • Patients taking specific homeopathic or phytotherapy treatments
  • Patients addicted to or using recreational drugs
  • Patients under guardianship or curatorship
  • Patients with serious kidney or lung problems, transplant recipients, HIV/AIDS, or terminal cancer

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 18 locations

1

Private Practice

Arlon, Belgium, 6700

Withdrawn

2

Clinique Saint-Luc (Bouge)

Bouge, Belgium, 5004

Actively Recruiting

3

Private Practice

Brussels, Belgium, 1020

Terminated

4

Private Practice

Écaussinnes-d'Enghien, Belgium, 7190

Terminated

5

Private Practice

Fontaine l'Êveque, Belgium, 6140

Suspended

6

Private Practice

Ghent, Belgium, 9942

Actively Recruiting

7

Private Practice

Gozée, Belgium, 6534

Terminated

8

Private Practice

Hamme-Mille, Belgium, 1320

Actively Recruiting

9

Private Practice

Juprelle, Belgium, 4450

Withdrawn

10

Private Practice

Mons, Belgium, 7000

Withdrawn

11

Private Practice

Namur, Belgium, 5000

Actively Recruiting

12

Private Practice

Namur, Belgium, 5000

Withdrawn

13

Private Practice

Oisquercq, Belgium, 1480

Terminated

14

Private Practice

Plancenoit, Belgium, 1380

Withdrawn

15

Private Practice

Quiévrain, Belgium, 7380

Withdrawn

16

Private Practice

Saint-Symphorien, Belgium, 7030

Actively Recruiting

17

Private Practice

Seneffe, Belgium, 7180

Actively Recruiting

18

Private Practice

Wavre, Belgium, 1300

Actively Recruiting

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Research Team

C

Charlotte Bolle

CONTACT

L

Laura FERTE

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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