Randomized, Placebo-controlled, Double Blind Study to Evaluate the Efficacy of 2LVERU®JUNIOR and 2LVERU® on the Treatment of Warts

NCT03977753 | Recruiting Phase 4

• 1 other identifier: LLB-2019-02
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 18

Brief 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. 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.

Conditions

Common Wart; Flat Wart; Plantar Wart

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (6)

• Disappearance of warts at 4 months.

  4 months

• Disappearance level (total disappearance, partial disappearance (50%), no modification, increase of number of warts) at 4 months

  4 months

• Warts recurrence at 9 months

  9 months

• Pain evaluation during the study by visual analogic scale and consumption of antalgic medication.

  6 months

• Safety: occurence of adverse events (AEs) and severe adverse events (SAEs), considered as related or not to the study drug.

  6 months

Study Arms (2)

2LVERU®/2LVERU® JUNIOR

EXPERIMENTAL

Group N°1: 2LVERU® or 2LVERU® JUNIOR treatment (6 months of treatment)

Drug: 2LVERU® or 2LVERU® JUNIOR

Placebo

PLACEBO COMPARATOR

Group N°2: Placebo treatment (6 months of treatment)

Drug: Placebo

Interventions

2LVERU® or 2LVERU® JUNIOR DRUG

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.

2LVERU®/2LVERU® JUNIOR

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Labo'Life: lead

Study Sites (18)

Private Practice

Arlon, 6700, Belgium

WITHDRAWN

Clinique Saint-Luc (Bouge)

Bouge, 5004, Belgium

RECRUITING

Private Practice

Brussels, 1020, Belgium

TERMINATED

Private Practice

Écaussinnes-d'Enghien, 7190, Belgium

TERMINATED

Private Practice

Fontaine l'Êveque, 6140, Belgium

SUSPENDED

Private Practice

Ghent, 9942, Belgium

RECRUITING

Private Practice

Gozée, 6534, Belgium

TERMINATED

Private Practice

Hamme-Mille, 1320, Belgium

RECRUITING

Private Practice

Juprelle, 4450, Belgium

WITHDRAWN

Private Practice

Mons, 7000, Belgium

WITHDRAWN

Private Practice

Namur, 5000, Belgium

RECRUITING

Private Practice

Namur, 5000, Belgium

WITHDRAWN

Private Practice

Oisquercq, 1480, Belgium

TERMINATED

Private Practice

Plancenoit, 1380, Belgium

WITHDRAWN

Private Practice

Quiévrain, 7380, Belgium

WITHDRAWN

Private Practice

Saint-Symphorien, 7030, Belgium

RECRUITING

Private Practice

Seneffe, 7180, Belgium

RECRUITING

Private Practice

Wavre, 1300, Belgium

RECRUITING

MeSH Terms

Conditions

Warts

Condition Hierarchy (Ancestors)

Papillomavirus Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Tumor Virus Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Charlotte Bolle

CONTACT

(0)497 49 13 74; charlotte.bolle@labolife.com

Laura FERTE

CONTACT

(0)499 71 79 64; laura.ferte@labolife.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2019
• First Posted: June 6, 2019
• Study Start: February 17, 2020
• Primary Completion (Estimated): December 16, 2026
• Study Completion (Estimated): March 16, 2027
• Last Updated: October 30, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (18)