Asclera® Injection was evaluated in a multicenter, randomized, double-blind, placebo and comparator-controlled trial (EASI-study) in patients with spider or reticular varicose veins. A total of 338 patients were treated with Asclera® [0.5% for spider veins (n=94), 1% for reticular veins (n=86), sodium tetradecyl sulfate (STS) 1% (n=105), or placebo (0.9% isotonic saline solution) (n= 53)] for either spider or reticular veins.
Patients received an intravenous injection in the first treatment session; repeat injections were given three and six weeks later if the previous injection was evaluated as unsuccessful (defined as 1, 2, or 3 on a 5-point scale).
Patients returned at 12 and 26 weeks after the last injection for final assessments. The primary effectiveness endpoint was improvement of veins judged by a blinded panel.
- 95% of patients treated with Asclera® showed good or complete treatment success as rated by physicians
- Asclera® treatment results were statistically significant when compared to placebo (p<0.0001) for the primary efficacy criterion "improvement of veins"
1 Treatment success was rated on a 5-point scale (1 = worse than before, 2 = same as before, 3 = moderate improvement, 4 = good improvement, 5 = complete treatment success) by a blinded panel.