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

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.

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Key information

Conditions

Microcystic Lymphatic Malformation Lymphangioma Neoplasm, Lymphatic Tissue Neoplasms Neoplasms by Histologic Type

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Arkansas Children's Hospital, Little Rock, Arkansas, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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.

Treatment and study plan

PTX-022

Drug

Safety and Efficacy of PTX-022 in the Treatment of Microcystic Lymphatic Malformations

Primary outcomes

Incidence of Treatment-Emergent Adverse Events

Time frame: 4 months

Sponsors and collaborators

Lead sponsor

Palvella Therapeutics, Inc.

Industry

Registry information

Official study 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

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2022
First posted: Sep 20, 2021
Registry last updated: Jan 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed