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

• Status: Recruiting
• Trial end date: 2022-07-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Palvella Therapeutics, Inc.

Criteria

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.