Evaluating the effectiveness of 2LVERU® for treating warts
Study to Evaluate the Efficacy of 2LVERU® JUNIOR and 2LVERU® on the Treatment of Warts.
This study is testing if a new treatment called 2LVERU® can help people aged 3 and older get rid of different types of warts better than a placebo.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 162 (estimated) |
| Ages | 3 Years and up |
| Sex | All |
| Sponsor | Labo'Life Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 18 sites (Arlon and 17 other locations) |
| Trial ID | NCT03977753 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the efficacy of 2LVERU® and 2LVERU® JUNIOR in treating common warts, flat warts, and plantar warts compared to a placebo. The study will involve patients aged 3 years and older who present with these types of warts during a visit to their healthcare provider. Participants will be randomly assigned to receive either the treatment or a placebo for six months, followed by a three-month follow-up period to evaluate wart disappearance and recurrence. The primary outcome will be the comparison of wart disappearance rates at the end of treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 3 years and older with common, flat, or plantar warts.
Not a fit: Patients who have received any curative wart treatment in the previous two months or those with immunosuppressive conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective option for patients suffering from warts, potentially leading to complete eradication of the lesions.
How similar studies have performed: While conventional treatments exist, this specific approach using 2LVERU® has not been extensively tested in similar studies, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Arlon and 17 other locations
- Private Practice — Arlon, Belgium (Withdrawn)
- Clinique Saint-Luc (Bouge) — Bouge, Belgium (Recruiting)
- Private Practice — Brussels, Belgium (Terminated)
- Private Practice — Écaussinnes-d'Enghien, Belgium (Terminated)
- Private Practice — Fontaine l'Êveque, Belgium (Suspended)
- Private Practice — Ghent, Belgium (Recruiting)
- Private Practice — Gozée, Belgium (Terminated)
- Private Practice — Hamme-Mille, Belgium (Recruiting)
- Private Practice — Juprelle, Belgium (Withdrawn)
- Private Practice — Mons, Belgium (Withdrawn)
- Private Practice — Namur, Belgium (Recruiting)
- Private Practice — Namur, Belgium (Withdrawn)
- Private Practice — Oisquercq, Belgium (Terminated)
- Private Practice — Plancenoit, Belgium (Withdrawn)
- Private Practice — Quiévrain, Belgium (Withdrawn)
- Private Practice — Saint-Symphorien, Belgium (Recruiting)
- Private Practice — Seneffe, Belgium (Recruiting)
- Private Practice — Wavre, Belgium (Recruiting)
Study contacts
- Study coordinator: Charlotte Bolle
- Email: charlotte.bolle@labolife.com
- Phone: (0)497 49 13 74
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.