Randomized, placebo-controlled, double-blind study to evaluate the efficacy of 2LVERU®JUNIOR and 2LVERU® on the treatment of warts. EVAsION Study

Phase 1

• Conditions: on genital warts infection; MedDRA version: 21.1Level: LLTClassification code: 10010115Term: Common warts Class: 10029104; MedDRA version: 20.0Level: LLTClassification code: 10035158Term: Plantar warts Class: 10029104; MedDRA version: 20.0Level: LLTClassification code: 10047828Term: Warts Class: 10029104; MedDRA version: 20.0Level: LLTClassification code: 10035150Term: Planar warts Class: 10029104; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: CTIS2024-514476-40-00
• Lead Sponsor: abo'Life Belgium

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-14
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 162

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 curatorship,

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main 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 Objective: - 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.;Primary end point(s): Disappearance of warts at the end of treatment (6-month visit)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):- Disappearance of warts at 4 months. - Disappearance level (total disappearance, partial disappearance (50%), no modification, increase of number of warts) at 4 months and 6 months, - Warts recurrence at 3-month visit post-treatment - Pain evaluation during the study by VAS and consumption of antalgic medication. - Safety: occurrence of adverse events (AEs) and severe adverse events (SAEs), considered as related or not to the study drug.