Topical Sirolimus for Microcystic Lymphatic Malformations

The purpose of this study is to evaluate the safety and tolerability of the study drug PTX-022. The study will enroll male and female patients between 13 and 60 years of age that have been diagnosed with a microcystic lymphatic malformation with a history of frequent leaking and/or bleeding. Subjects will receive PTX-022, which is a topical gel that will be applied directly to the lesion. Participation will last for about 20 weeks and will include 8 visits. Study visits include the following assessments: physical exams, vital signs, blood and urine tests, photography of the lesions, and the completion of diaries and questionnaires. Reimbursement for travel expenses and compensation for participation may be provided.