RecruitingPhase 4

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

Belgium162 participantsStarted 2020-02-17

Plain-language 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.

Who can participate

Age range

3 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Disappearance of warts at the end of treatment (6-month visit)

Timeframe: 6 months

Trial details

NCT IDNCT03977753

SponsorLabo'Life

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12-16

Contact for this trial

Charlotte Bolle

(0)497 49 13 74 charlotte.bolle@labolife.com

View on ClinicalTrials.gov More Common Wart trials