RecruitingPhase 4NCT03977753

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

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


Sponsor

Labo'Life

Enrollment

162 participants

Start Date

Feb 17, 2020

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 3 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called 2LVERU® or 2LVERU® JUNIOR and a drug called Placebo for people with common wart, flat wart, and other related conditions. The study is currently recruiting participants at 18 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG2LVERU® 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.

DRUGPlacebo

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(18)

Private Practice

Arlon, Belgium

Clinique Saint-Luc (Bouge)

Bouge, Belgium

Private Practice

Brussels, Belgium

Private Practice

Écaussinnes-d'Enghien, Belgium

Private Practice

Fontaine l'Êveque, Belgium

Private Practice

Ghent, 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, Belgium

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NCT03977753


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