A Randomized, Double-Blind, Placebo-Controlled Study of the Effect of a High-Potency Topical Corticosteroid After Sclerotherapy for Reticular and Telangiectatic Veins of the Lower Extremities.

ABSTRACT

BACKGROUND: Although typically mild, transient, and expected, most adverse events (AEs) postsclerotherapy are inflammatory in nature. OBJECTIVE: To evaluate the effects of a high-potency topical corticosteroid (TC) applied immediately postsclerotherapy. MATERIALS AND METHODS: Subjects undergoing bilateral lower extremity sclerotherapy with polidocanol had extremities randomized to a single application of betamethasone dipropionate and placebo saline solutions immediately post-treatment in a double-blind manner. Adverse events were assessed for each extremity by subjects at t = 0 (preapplication) and t = 15 (15 minutes postapplication) and by an investigator at t = 0 and t = 15, and at Days 14 and 60. Subjects and investigator evaluated efficacy with a quartile improvement scale. RESULTS: Sixteen female subjects completed the study. Subjects reported no statistically significant differences in AEs between TC and placebo at either t = 0 or t = 15. Investigator scores for erythema and swelling/urtication were not significantly different between groups at the same time points. Although most subjects demonstrated 26% to 75% improvement at Day 60, results were not significantly different between extremities on subject and investigator evaluation. CONCLUSION: High-potency TC application immediately postsclerotherapy produced no statistically significant differences in subject- and investigator-assessed AEs and clearance rates compared with placebo. Foam sclerotherapy with polidocanol is safe and effective for the treatment of lower extremity reticular veins.