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

Trial ID or NCT#

NCT05050149

Status

not recruiting iconNOT RECRUITING

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

Eligibility Criteria

Ages Eligible for Study: Older than 6 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * Participants must be 6 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:
  1. * 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.
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Investigator(s)

Joyce Teng, MD, PhD
Joyce Teng, MD, PhD
Dermatologist, Pediatric dermatologist
Professor of Dermatology and, by courtesy, of Pediatrics

Contact us to find out if this trial is right for you.

Contact

Pediatric Dermatology Research
650-723-0636

View on ClinicalTrials.gov