A Study to Evaluate Topical VT30 to Treat Patients with Venous/Lymphatic Malformations Associated with PIK3CA or TEK Gene Mutations
Rochester, MN
The primary purpose of this two-part study is to evaluate the safety and tolerability of VT30.
Part 1 is a 4-week treatment, open-label, 4-sequence, escalating repeat-application cohort study, with intra-subject and inter-cohort dose escalation.
Part 2 is a 12-week treatment, randomized, placebo-controlled, double-blind, safety and exploratory effectiveness study. Part 2 will be initiated only after the successful completion of Part 1 with results that demonstrate the general safety and tolerability of topically applied VT30.