Randomized study to evaluate 2LVERU® JUNIOR and 2LVERU® efficacy on the treatment of warts.

Randomized study to evaluate 2LVERU® JUNIOR and 2LVERU® efficacy on the treatment of warts. Protocol EVAsION - EVAsION

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-001443-52-BE

Enrollment

260

Registered

2019-06-03

Start date

2019-11-13

Completion date

Unknown

Last updated

2024-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non genital warts infection MedDRA version: 20.0 Level: LLT Classification code 10035150 Term: Planar warts System Organ Class: 100000004864 MedDRA version: 20.0 Level: LLT Classification code 10035158 Term: Plantar warts System Organ Class: 100000004864 MedDRA version: 20.0 Level: LLT Classification code 10047828 Term: Warts System Organ Class: 100000004864 MedDRA version: 21.1 Level: LLT Classification code 10010115 Term: Common warts System Organ Class: 100000004864

Interventions

Trade Name: 2LVERU® Product Name: 2LVERU® Product Code: NA Pharmaceutical Form: Pillules Trade Name: 2LVERU® JUNIOR Product Name: 2LVERU® JUNIOR Product Code: NA Pharmaceutical Form: Pillules

Eligibility

Sex/Gender

All

Inclusion 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 with at least one wart eligible for cryotherapy, - 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). Are the trial subjects under 18? yes Number of subjects for this age range: 130 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 120 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

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 curatorship, (*) important renal or respiratory insufficiency, transplanted or grafted patients, HIV/AIDS, terminal cancer.

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluation of the efficacy of 2LVERU® JUNIOR and 2LVERU® on the treatment of warts at the end of treatment (6 month visit).;Secondary Objective: - Evaluate the non-inferiority efficacy of 2LVERU® JUNIOR and 2LVERU® vs cryotherapy on the treatment of warts at the end of treatment. - Evaluation of the pain related to warts and treatment in 2LVERU® JUNIOR and 2LVERU® arm vs cryotherapy arm during the study. - Evaluation of the efficacy of 2LVERU® JUNIOR and 2LVERU® on the treatment of warts at 4 months. - Evaluation according to 4 levels (total disappearance, partial disappearance (50%), no modification, increase of number of warts) of the efficacy of 2LVERU® JUNIOR and 2LVERU® vs cryotherapy on the treatment of warts at the end of treatment. - Compare the efficacy of 2LVERU® JUNIOR and 2LVERU® vs cryotherapy with regards to emergence of warts at 3-month post treatment visit. - Safety issues. ;Primary end point(s): Disappearance of warts at the end of treatment visit (6 months' visit) in the 2LVERU® JUNIOR or 2LVERU®.;Timepoint(s) of evaluation of this end point: 6 months	—

Measure

Time frame

Main Objective: Evaluation of the efficacy of 2LVERU® JUNIOR and 2LVERU® on the treatment of warts at the end of treatment (6 month visit).;Secondary Objective: - Evaluate the non-inferiority efficacy of 2LVERU® JUNIOR and 2LVERU® vs cryotherapy on the treatment of warts at the end of treatment. - Evaluation of the pain related to warts and treatment in 2LVERU® JUNIOR and 2LVERU® arm vs cryotherapy arm during the study. - Evaluation of the efficacy of 2LVERU® JUNIOR and 2LVERU® on the treatment of warts at 4 months. - Evaluation according to 4 levels (total disappearance, partial disappearance (50%), no modification, increase of number of warts) of the efficacy of 2LVERU® JUNIOR and 2LVERU® vs cryotherapy on the treatment of warts at the end of treatment. - Compare the efficacy of 2LVERU® JUNIOR and 2LVERU® vs cryotherapy with regards to emergence of warts at 3-month post treatment visit. - Safety issues. ;Primary end point(s): Disappearance of warts at the end of treatment visit (6 months' visit) in the 2LVERU® JUNIOR or 2LVERU®.;Timepoint(s) of evaluation of this end point: 6 months

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Secondary

Measure	Time frame
Secondary end point(s): - Disappearance of warts at the end of treatment visit. - Pain evaluation during the study by VAS and consumption of antalgic medication. - Numbers of warts disappeared at 4-month visit. - Disappearance level (total disappearance, partial disappearance (50%), no modification, increase of number of warts) at the end of treatment. - Warts recurrence at 3-month visit post-treatment - Safety: occurence of adverse events (AEs) and severe adverse events (SAEs), considered as related or not to the study drug. ;Timepoint(s) of evaluation of this end point: - End of 2LVERU® JUNIOR or 2LVERU® treatment and end of cryotherapy treatment. - Until 6 months, - 4 months, - End of 2LVERU® JUNIOR or 2LVERU® treatment (6 months) and end of cryotherapy treatment, - 3 months' visit post treatment, - Until 6 months.	—

Measure

Time frame

Secondary end point(s): - Disappearance of warts at the end of treatment visit. - Pain evaluation during the study by VAS and consumption of antalgic medication. - Numbers of warts disappeared at 4-month visit. - Disappearance level (total disappearance, partial disappearance (50%), no modification, increase of number of warts) at the end of treatment. - Warts recurrence at 3-month visit post-treatment - Safety: occurence of adverse events (AEs) and severe adverse events (SAEs), considered as related or not to the study drug. ;Timepoint(s) of evaluation of this end point: - End of 2LVERU® JUNIOR or 2LVERU® treatment and end of cryotherapy treatment. - Until 6 months, - 4 months, - End of 2LVERU® JUNIOR or 2LVERU® treatment (6 months) and end of cryotherapy treatment, - 3 months' visit post treatment, - Until 6 months.

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Countries

Belgium

Contacts

Public ContactClin Research Coord, Léa FERRAND

LABO'LIFE France

lea.ferrand@labolife.com+336 42 62 43 72

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026