Klotten, Germany
Randomized, Placebo-controlled, Double Blind Study to Evaluate the Efficacy of 2LVERU®JUNIOR and 2LVERU® on the Treatment of Warts
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.
Phase
4Span
370 weeksSponsor
Labo'LifeSeneffe
Recruiting