NCT03977753RecruitingPhase 4
Randomized, Placebo-controlled, Double Blind Study to Evaluate the Efficacy of 2LVERU®JUNIOR and 2LVERU® on the Treatment of Warts
Study to Evaluate the Efficacy of 2LVERU® JUNIOR and 2LVERU® on the Treatment of Warts.
Source: ClinicalTrials.gov · Last updated 31 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 162 (estimated)
- First submitted
- 4 Jun 2019
- Start date
- 17 Feb 2020
- Primary completion date
- 16 Dec 2028
- Lead sponsor
- Labo'Life
- NCT number
- NCT03977753
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 162
- From 17 Feb 2020 to the primary completion date, 16 Dec 2028
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 having received immunotherapy or micro-immunotherapy during the last 6 months,
- Patients who participated in a clinical study in the previous 2-months period,
- Patients addicted to or using recreational drugs,
Other illness
- Patients with severe immunodeficiency disease requiring long term treatment (\*) or patients under chemotherapy or radiotherapy,
- Patient under guardianship and/or curators, (\*) important renal or respiratory insufficiency, transplanted or grafted patients, HIV/AIDS, terminal cancer.
Other
- Patients under immunosuppressive treatment,
- Patients with known lactose intolerance,
- Pregnant or breastfeeding women,
- 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 under listed homeopathic or phytotherapy treatment (see protocol),
Who the study is looking for
- 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).
Age in the registry: 3 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinique Saint-Luc (Bouge) Coordinator of this site? Confirm its status | Bouge | Belgium | Recruiting |
| Private Practice Coordinator of this site? Confirm its status | Ghent | Belgium | Recruiting |
| Private Practice Coordinator of this site? Confirm its status | Oisquercq | Belgium | Terminated |
| Private Practice Coordinator of this site? Confirm its status | Saint-Symphorien | Belgium | Recruiting |
| Private Practice Coordinator of this site? Confirm its status | Seneffe | Belgium | Recruiting |
| Private Practice Coordinator of this site? Confirm its status | Wavre | Belgium | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.