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Randomized, Placebo-controlled, Double Blind Study to Evaluate the Efficacy of 2LVERU®JUNIOR and 2LVERU® on the Treatment of Warts
Sponsor: Labo'Life
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.
Official title: Study to Evaluate the Efficacy of 2LVERU® JUNIOR and 2LVERU® on the Treatment of Warts.
Key Details
Gender
All
Age Range
3 Years - Any
Study Type
INTERVENTIONAL
Enrollment
162
Start Date
2020-02-17
Completion Date
2027-03-16
Last Updated
2024-10-30
Healthy Volunteers
No
Conditions
Interventions
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 (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