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Mt Kisco, New York

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  • 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

    4

    Span

    370 weeks

    Sponsor

    Labo'Life

    Seneffe

    Recruiting

1-1 of 1
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