February 6, 2012
BTG International reported results from a phase II trial of Varisolve microfoam for the treatment of varicose veins. This randomized, blinded trial, VANISH-2, enrolled 235 subjects with symptomatic and visible varicose veins and saphenofemoral junction incompetence who were randomized to treatment with one of three dose concentrations (0.125%, 0.5% or 1.0%) of Varisolve microfoam or placebo. The primary endpoint was an improvement in symptoms recorded using a patient-reported outcomes instrument, VVSymQ at eight weeks following treatment. The 0.5% and 1.0% dose concentrations of Varisolve microfoam demonstrated a statistically significant improvement in symptoms compared to placebo (p<0.0001). The subjects treated with Varisolve microfoam 0.5 and 1.0% also reported a statistically significant improvement in compared with placebo (p<0.0001 and p<0.0001, respectively). There were no serious or unexpected adverse events.