Randomized, Placebo-controlled, Double Blind Study to Evaluate the Efficacy of 2LVERU®JUNIOR and 2LVERU® on the Treatment of Warts
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 2LVERU® or 2LVERU® JUNIOR, Placebo.
- Who it may be relevant to
- Registry conditions: Common Wart, Flat Wart, Plantar Wart. Basic parameters: from 3 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Study to Evaluate the Efficacy of 2LVERU® JUNIOR and 2LVERU® on the Treatment of Warts.
Overview
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.
Detailed 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.
Interventions
- Drug 2LVERU® or 2LVERU® JUNIOR
The treatment schema consists in taking the content of one capsule a day, 15-30 minutes before breakfast, on an empty stomach, sequentially, according to capsules' numerical order: 1 through 10. When capsule number 10 is taken, capsule 1 of the next blister should be taken on the next day to continue the treatment. The duration of treatment will be 6 months of continuous intake of the content of 1 capsule/day. - Drug Placebo
The treatment schema consists in taking the content of one capsule a day, 15-30 minutes before breakfast, on an empty stomach, sequentially, according to capsules' numerical order: 1 through 10. When capsule number 10 is taken, capsule 1 of the next blister should be taken on the next day to continue the treatment. The duration of treatment will be 6 months of continuous intake of the content of 1 capsule/day.
Primary outcome measures
- Disappearance of warts at the end of treatment (6-month visit) [Time frame: 6 months]
Secondary outcome measures (6)
- Disappearance of warts at 4 months. [Time frame: 4 months]
- Disappearance level (total disappearance, partial disappearance (50%), no modification, increase of number of warts) at 4 months [Time frame: 4 months]
- Warts recurrence at 9 months [Time frame: 9 months]
- Pain evaluation during the study by visual analogic scale and consumption of antalgic medication. [Time frame: 6 months]
- Safety: occurence of adverse events (AEs) and severe adverse events (SAEs), considered as related or not to the study drug. [Time frame: 6 months]
- Disappearance level (total disappearance, partial disappearance (50%), no modification, increase of number of warts) at 6 months [Time frame: 6 months]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Belgium · 18 centers
- Private Practice — Arlon
- Clinique Saint-Luc (Bouge) — Bouge
- Private Practice — Brussels
- Private Practice — Écaussinnes-d'Enghien
- Private Practice — Fontaine l'Êveque
- Private Practice — Ghent
- Private Practice — Gozée
- Private Practice — Hamme-Mille
- … and 10 more centers
Identifiers
NCT: NCT03977753 · LLB-2019-02