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

Study Status: Completed

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.

Sex: ALL
Minimum Age: 6 Years

Researchers look for people who fit a certain description, called eligibility criteria. Below are the inclusion and exclusion criteria for study participants:

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.

Conditions

Microcystic Lymphatic Malformation

Intervention/Treatment

DRUG : PTX-022

Sponsor

Palvella Therapeutics, Inc.

Phase

PHASE2