Conditions: Varicose Veins
Keywords: varicose veins
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 235
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 Endovenous Microfoam (PEM) compared to vehicle (inactive solution) in treating the symptoms and appearance of varicose veins.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None

Interventions: intervention 1: polidocanol injectable foam, 0.125% intervention 2: polidocanol injectable foam, 0.5% intervention 3: polidocanol injectable foam, 1.0% intervention 4: Vehicle
Intervention descriptions: intervention 1: active placebo for blinding intervention 2: 0.5% polidocanol foam injection intervention 3: 1.0% polidocanol foam injection intervention 4: injection of vehicle comparator

Protocol document: