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PTX-022 in the Treatment of Microcystic Lymphatic Malformations
This study is now recruiting.
The purpose of this study is to see if a new investigational topical (applied to the skin) formulation of sirolimus, PTX-022 (the study drug), is safe and effective in treating participants with microcystic Lymphatic Malformations.
Who Do I Contact?
If you are interested in participating in the study or want to learn more please contact our study team at CVAPResearch [at] chop.edu or 267-426-0743.
Eligibility & Criteria
IRB #:
23-021775
Official Title:
SELVA: A Multicenter, Phase 3 Baseline-Controlled Study Evaluating the Safety and Efficacy of PTX-022 in the Treatment of Microcystic Lymphatic Malformations
Study Phase:
Phase III
Eligible Age Range:
6 - 60 Years
Gender:
All
Visit Criteria
This study will enroll patients between 6 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 at least 14 months and will include 5 in-person visits and at least 3 remote visits (by phone call). Study visits include the following assessments: physical exams, vital signs, safety blood and urine tests, research blood tests, photography of the lesions, completion of interviews, and questionnaires. Reimbursement for travel expenses and compensation for participation may be provided.
