Common WartPhase 4EVAsIONNCT03977753
Randomized, Placebo-controlled, Double Blind Study to Evaluate the Efficacy of 2LVERU®JUNIOR and 2LVERU® on the Treatment of Warts
A Phase 4 study testing 2LVERU® or 2LVERU® JUNIOR in people with Common Wart and Flat Wart, run by Labo'Life at 6 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Common Wart, Flat Wart, Plantar Wart
- What is being tested?
- 2LVERU® or 2LVERU® JUNIOR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 162 participants
- Where
- 6 sitesBelgium
- Study dates
- 17 Feb 2020to 16 Feb 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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,
Show all 12Show fewer
- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Belgium6 sites, 5 recruiting
- Recruiting
Clinique Saint-Luc (Bouge)
Bouge, 5004
Audrey SCHILS, Dr
Audrey SCHILS, Dr
- Recruiting
Private Practice
Ghent, 9942
Filip Dr Verrue
Filip Dr Verrue
- Terminated
Private Practice
Oisquercq, 1480
- Recruiting
Private Practice
Saint-Symphorien, 7030
Nathalie BEAUCHOT, Dr
Nathalie BEAUCHOT, Dr
- Recruiting
Private Practice
Seneffe, 7180
Kristel MESTDAGH, Dr
Kristel MESTDAGH, Dr
- Recruiting
Private Practice
Wavre, 1300
Wolfram FINK, Dr
Wolfram Fink, Dr
About this study
Official title: Study to Evaluate the Efficacy of 2LVERU® JUNIOR and 2LVERU® on the Treatment of Warts.
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.
Read more
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.
Read the 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.
- Conditions
- Common Wart, Flat Wart, Plantar Wart
- Being tested
- 2LVERU® or 2LVERU® JUNIOR, Placebo
- Medical subject headings
- Warts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2LVERU® or 2LVERU® JUNIORDrug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 2LVERU®/2LVERU® JUNIOR | Experimental | Group N°1: 2LVERU® or 2LVERU® JUNIOR treatment (6 months of treatment) Receives: Drug: 2LVERU® or 2LVERU® JUNIOR |
| Placebo | Placebo comparator | Group N°2: Placebo treatment (6 months of treatment) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (6)
Disappearance of warts at 4 months.
Measured: 4 months
Disappearance level (total disappearance, partial disappearance (50%), no modification, increase of number of warts) at 4 months
Measured: 4 months
Warts recurrence at 9 months
Measured: 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)
Measured: 6 months
Safety: occurence of adverse events (AEs) and severe adverse events (SAEs), considered as related or not to the study drug.
Measured: 6 months
Disappearance level (total disappearance, partial disappearance (50%), no modification, increase of number of warts) at 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2019
- Study start17 Feb 2020
- Primary completion16 Dec 2028 (estimated)
- Study completion16 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Common WartStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Labo'Life
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03977753
- Sponsor's protocol ID
- LLB-2019-02
- Acronym
- EVAsION
- Status last verified
- Aug 2026
- First submitted
- 4 Jun 2019
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate the Efficacy of 2LVERU® JUNIOR and 2LVERU® on the Treatment of Warts.
- ClinicalTrials.gov ID
- NCT03977753
- Acronym / sponsor ID
- EVAsION / LLB-2019-02
- Conditions
- Common Wart, Flat Wart, Plantar Wart
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Labo'LifeIndustry (pharma, biotech, devices)
- Study start
- 17 Feb 2020 (actual)
- Primary completion
- 16 Dec 2028 (estimated)
- Study completion
- 16 Feb 2029 (estimated)
- First posted
- 6 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2LVERU®/2LVERU® JUNIOR | Experimental | Drug: 2LVERU® or 2LVERU® JUNIORGroup N°1: 2LVERU® or 2LVERU® JUNIOR treatment (6 months of treatment) |
| Placebo | Placebo comparator | Drug: PlaceboGroup N°2: Placebo treatment (6 months of treatment) |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (12 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2LVERU® or 2LVERU® JUNIORThe 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 | 2LVERU®/2LVERU® JUNIOR |
| PlaceboThe 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 |
Primary outcome
Disappearance of warts at the end of treatment (6-month visit)
Time frame: 6 months
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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- European platform for clinical trialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 2LVERU® or 2LVERU® JUNIOR in people with Common Wart and Flat Wart, run by Labo'Life at 6 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charlotte Bolle ((0)497 49 13 74 ext. +32, charlotte.bolle@labolife.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disappearance of warts at the end of treatment (6-month visit) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.