The study is a multi-center prospective, randomized, double-blind, placebo-controlled
evaluation of the safety and efficacy of a topically applied formulation of rapamycin to
cutaneous angiofibromas in subjects with Tuberous Sclerosis Complex (TSC). Subjects will
apply either the topical vehicle containing rapamycin or the topical vehicle alone nightly to
their angiofibromas for six months.
The primary goal of this study is to evaluate the efficacy of the topical medication for
reduction of cutaneous angiofibromas in patients with TSC. The secondary goal of this study
is to confirm the safety of the topical medication.
Phase:
Phase 2
Details
Lead Sponsor:
The University of Texas Health Science Center, Houston