Topical sirolimus therapy for cutaneous vascular anomalies: A randomized phase II clinical trial.

The efficacy, safety, and optimal concentration of topical sirolimus gel for treatment of cutaneous lesions of vascular anomalies requires evaluation. This study was a multicenter, double-blind, placebo-controlled, parallel-group, phase II randomized clinical trial. We enrolled patients with venous malformation (n = 27), lymphatic malformation (n = 14), tufted angioma (n = 8), or kaposiform hemangioendothelioma (n = 1).