Conditions: Varicose Veins
Keywords: Varicose Veins
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 279
Healthy volunteers: no

Brief summary:
Varicose veins are enlarged, noticeably bulging veins, which commonly occur in the legs and may cause discomfort. In this study, patients with varicose veins in the legs will be participating. The purpose of this research study is to evaluate the safety and effectiveness of three different concentrations of an investigational drug, polidocanol injectable foam compared to vehicle (inactive solution) in treating the symptoms and appearance of varicose veins.

Detailed description:

Arms:
arm 1: Polidocanol injectable foam 0.125% arm 2: Polidocanol injectable foam 0.5% arm 3: Polidocanol injectable foam 1.0% arm 4: Polidocanol injectable foam 2.0% arm 5: Injection of vehicle comparator

Interventions: intervention 1: Polidocanol injectable foam (PEM) intervention 2: Placebo Vehicle
Intervention descriptions: intervention 1: Injection of Polidocanol injectable foam intervention 2: Placebo vehicle

Protocol document: