A Phase 4 interventional study of 2LVERU® or 2LVERU® JUNIOR and Placebo in Common Wart, Flat Wart and Plantar Wart, sponsored by Labo'Life. Recruiting at 6 sites in Belgium. Open to participants aged 3 Years and older. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by Labo'Life · Phase 4, Interventional, and Treatment
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.
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
Treatment phase:
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:
171 studies on the registry are indexed under Warts; 35 are open to participants now.
This study's planned enrollment of 162 is above the median of 70 across 155 interventional studies indexed under Warts.
Browse Warts studies →Labo'Life is the lead sponsor of 6 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Group N°1: 2LVERU® or 2LVERU® JUNIOR treatment (6 months of treatment)
Drug: 2LVERU® or 2LVERU® JUNIOR
Group N°2: Placebo treatment (6 months of treatment)
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.
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.
Disappearance of warts at the end of treatment (6-month visit)
A wart will be considered as disappeared if the colour and texture of the skin has returned to normal and can no longer be felt to the touch.
Time frame: 6 months
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.
Minimum value: 0 (better outcome) Maximum Value: 10 (worse outcome)
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
Not enrolling at this site.
Plan to share: No
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