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

Trial ID or NCT#

NCT05050149

Status

recruiting iconRECRUITING

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 13 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  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

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Contact

Pediatric Dermatology Research
650-723-0636

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View on ClinicalTrials.gov