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.

Inclusion criteria

• 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).

Exclusion criteria

• Patients who have received any curative warts treatment in the previous 2 months prior to the study,
• Patients who have received any homeopathic treatment in the previous 2 months prior to the study,
• Patients under immunosuppressive treatment,
• Patients having received immunotherapy or micro-immunotherapy during the last 6 months,
• Patients with known lactose intolerance,
• Pregnant or breastfeeding women,
• Patients who participated in a clinical study in the previous 2-months period,
• Patients (and/or parents of patients if necessary) who are not sufficiently motivated to engage on the total study follow-up period, or likely to travel or to move before the end of the study,
• Patients with severe immunodeficiency disease requiring long term treatment (*) or patients under chemotherapy or radiotherapy,
• Patients under listed homeopathic or phytotherapy treatment (see protocol),
• Patients addicted to or using recreational drugs,
• Patient under guardianship and/or curators, (*) important renal or respiratory insufficiency, transplanted or grafted patients, HIV/AIDS, terminal cancer.