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

Who is this study for? Patients with Cutaneous Warts
What treatments are being studied? 2LVERU® or 2LVERU® JUNIOR
Status: Recruiting
Location: See all (18) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 3
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
Belgium
Private Practice
WITHDRAWN
Arlon
Clinique Saint-Luc (Bouge)
RECRUITING
Bouge
Private Practice
TERMINATED
Brussels
Private Practice
TERMINATED
Écaussinnes-d'enghien
Private Practice
SUSPENDED
Fontaine L'êveque
Private Practice
RECRUITING
Ghent
Private Practice
TERMINATED
Gozée
Private Practice
RECRUITING
Hamme-mille
Private Practice
WITHDRAWN
Juprelle
Private Practice
WITHDRAWN
Mons
Private Practice
RECRUITING
Namur
Private Practice
WITHDRAWN
Namur
Private Practice
TERMINATED
Oisquercq
Private Practice
WITHDRAWN
Plancenoit
Private Practice
WITHDRAWN
Quiévrain
Private Practice
RECRUITING
Saint-symphorien
Private Practice
RECRUITING
Seneffe
Private Practice
RECRUITING
Wavre
Contact Information
Primary
Charlotte Bolle
charlotte.bolle@labolife.com
(0)497 49 13 74
Backup
Laura FERTE
laura.ferte@labolife.com
(0)499 71 79 64
Time Frame
Start Date: 2020-02-17
Estimated Completion Date: 2027-03-16
Participants
Target number of participants: 162
Treatments
Experimental: 2LVERU®/2LVERU® JUNIOR
Group N°1: 2LVERU® or 2LVERU® JUNIOR treatment (6 months of treatment)
Placebo_comparator: Placebo
Group N°2: Placebo treatment (6 months of treatment)
Authors
Related Therapeutic Areas
Sponsors
Leads: Labo'Life

This content was sourced from clinicaltrials.gov