Study to Evaluate the Efficacy of 2LVERU® JUNIOR and 2LVERU® on the Treatment of Warts. (EVAsION)

  • STATUS
    Recruiting
  • End date
    Mar 16, 2024
  • participants needed
    162
  • sponsor
    Labo'Life
Updated on 24 October 2022

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.

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.

Details
Condition Common Wart, Flat Wart, Plantar Wart
Treatment Placebo, 2LVERU® or 2LVERU® JUNIOR
Clinical Study IdentifierNCT03977753
SponsorLabo'Life
Last Modified on24 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients, male or female, aged 3 years and older
Patients with common warts (Verruca vulgaris), and/or plantar warts (Verruca plantaris), and/or flat warts (Verruca plana)
Patients (and/or parents if necessary) having the faculties to understand and respect the constraints of the study
Signature of the Informed Consent Form by the patient (and/or parents if necessary)

Exclusion Criteria

Patients who have received any curative warts treatment in the previous 2 months prior to the study
Patients who have received any homeopathic treatment in the previous 2 months prior to the study
Patients under immunosuppressive treatment
Patients having received immunotherapy or micro-immunotherapy during the last 6 months
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 sufficiently motivated to engage on the total study follow-up period, or likely to travel or to move before the end of the study
Patients with severe immunodeficiency disease requiring long term treatment () or patients 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 respiratory insufficiency, transplanted or grafted patients, HIV/AIDS, terminal cancer
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note