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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Labo'Life Belgium

Participant type

Pediatric, Patients

Age range

0-17 years, 18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Virus Diseases [C02]

Trial duration

3 Jun 2024 → ongoing

Decision date (initial)

2024-05-31

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-514476-40-00

EudraCT number

2019-001443-52

ClinicalTrials.gov

NCT03977753

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

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 1

1. - 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.

Conditions and MedDRA coding

Non genital warts infection

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. - 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 1

1. - 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,

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Disappearance of warts at the end of treatment (6-month visit)

Secondary endpoints 1

1. - 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.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Labo'Life Belgium

Sponsor organisation

Labo'Life Belgium

Address

Avenue D'Ecolys 2 Bus 36

City

Namur

Postcode

5020

Country

Belgium

Scientific contact point

Organisation

Labo'Life Belgium

Contact name

Clinical Project Manager

Public contact point

Organisation

Labo'Life Belgium

Contact name

Clinical Project Manager

Locations

1 EU/EEA country · 11 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

1 submissions — initial application plus substantial / non-substantial modifications