A Phase 2, Baseline-Controlled Study Evaluating the Safety and Efficacy of PTX-022 (Sirolimus) Topical Gel 3.9% in the Treatment of Cutaneous Venous Malformations

Running, not enrolling · Phase 2

Conditions studied: Cutaneous Venous Malformations

In brief

A Phase 2, Baseline-Controlled Study Evaluating the Safety and Efficacy of PTX022 (sirolimus) Topical Gel 3.9% in the Treatment of Cutaneous Venous Malformations

Key facts

Study ID: NCT06653842
Run by: Palvella Therapeutics, Inc.
People needed: 15
Starts: 2024-12-20
Expected to finish: 2026-03-01
Last updated by the study team: 2026-03-27

Who can join

Age: 6 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

The participant's treatment area is mainly in any wet mucosa or within the orbital rim. For clarification, no part of the venous malformation should be evaluated or treated if it in mucosa. External genital presentation is permitted.
The participant has a known pervasive extension of the lesion into mucosa, bone or tissue (as determined by diagnostic or the investigator) that would impair the ability of the investigator to evaluate the cutaneous components of the lesion.

Where it is running

Children's Hospital of Orange County — Irvine, California, United States
Stanford University — Palo Alto, California, United States
Colorado Children's Hospital — Aurora, Colorado, United States
Johns Hopkins — Baltimore, Maryland, United States
Minnesota Clinical Study Center — New Brighton, Minnesota, United States
Mayo Clinic — Rochester, Minnesota, United States
University of North Carolina — Chapel Hill, North Carolina, United States
Cleveland Clinic — Cleveland, Ohio, United States
Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
University of Utah Health — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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