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

Plantar Wart Clinical Trial

— EVAsION  

Official title:

Study to Evaluate the Efficacy of 2LVERU® JUNIOR and 2LVERU® on the Treatment of Warts.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03977753
• Other study ID #: LLB-2019-02
• Status: Recruiting
• Phase: Phase 4
• Start date: February 17, 2020
• Est. completion date: March 16, 2024

Study information

• Verified date: October 2023
• Source: Labo'Life
• Contact: Charlotte Bolle
• Phone: (0)497 49 13 74
• Email: charlotte.bolle[@]labolife.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 162
• Est. completion date: March 16, 2024
• Est. primary completion date: December 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Common Wart
• Flat Wart
• Plantar Wart
• Warts

Intervention

Drug:
• 2LVERU® or 2LVERU® JUNIOR
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
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.

Locations

Country	Name	City	State
Belgium	Private Practice	Arlon
Belgium	Clinique Saint-Luc (Bouge)	Bouge
Belgium	Private Practice	Brussel
Belgium	Private Practice	Ecaussinnes-d'enghien
Belgium	Private Practice	Fontaine l'Êveque
Belgium	Private Practice	Gent
Belgium	Private Practice	Gozée
Belgium	Private Practice	Hamme-Mille
Belgium	Private Practice	Juprelle
Belgium	Private Practice	Mons
Belgium	Private Practice	Namur
Belgium	Private Practice	Namur
Belgium	Private Practice	Oisquercq
Belgium	Private Practice	Plancenoit
Belgium	Private Practice	Quiévrain
Belgium	Private Practice	Saint-Symphorien
Belgium	Private Practice	Seneffe
Belgium	Private Practice	Wavre

Sponsors (1)

Lead Sponsor	Collaborator
Labo'Life

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Disappearance of warts at 4 months.		4 months
Secondary	Disappearance level (total disappearance, partial disappearance (50%), no modification, increase of number of warts) at 4 months		4 months
Secondary	Warts recurrence at 9 months		9 months
Secondary	Pain evaluation during the study by visual analogic scale and consumption of antalgic medication.	Minimum value: 0 (better outcome) Maximum Value: 10 (worse outcome)	6 months
Secondary	Safety: occurence of adverse events (AEs) and severe adverse events (SAEs), considered as related or not to the study drug.		6 months
Secondary	Disappearance level (total disappearance, partial disappearance (50%), no modification, increase of number of warts) at 6 months		6 months