Study Evaluating the Safety and Efficacy of PTX-022 (QTORIN Sirolimus) in the Treatment of Microcystic Lymphatic Malformations

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Trial ID: NCT05050149

Purpose

This study evaluates the safety and efficacy of PTX-022 (sirolimus) Topical Gel 3.9% w/w in the treatment of Microcystic Lymphatic Malformations. The participant will receive 3 months of PTX-022 treatment by the end of the study.

Official Title

A Multicenter, Phase 2, Open-Label Study Evaluating The Safety And Efficacy of Sirolimus 3.9% Topical Gel (PTX-022) In The Treatment of Microcystic Lymphatic Malformations

Stanford Investigator(s)

Joyce Teng, MD, PhD
Joyce Teng, MD, PhD

Professor of Dermatology and, by courtesy, of Pediatrics

Eligibility


Inclusion Criteria:

   - Participants must be 13 years or older

   - Diagnosed with Microcystic Lymphatic Malformations

   - Able and willing to comply with all protocol-required activities

   - Willing and able to provide written informed consent

Exclusion Criteria:

   - Any significant concurrent condition that could adversely affect participation.

   - Any history of allergy or hypersensitivity to sirolimus, or sirolimus-like medications
   or to PTX-022

   - Patient's deemed by the investigator as unwilling or unable to remain compliant with
   all tests and procedures, including adherence to study drug administration and other
   protocol-required activities.

Intervention(s):

drug: PTX-022

Recruiting

I'm Interested

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Pediatric Dermatology Research
650-723-0636