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Clinical Trials in the USA / NCT06653842
Active, not recruiting Phase 2

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

NCT06653842 · tracked via the Priya Life Science USA tracker
Sponsor
Palvella Therapeutics, Inc.
Phase
Phase 2
Started
2024-12-20
Last updated
2026-03-27

Condition(s) studied

Cutaneous Venous Malformations

Investigational drug(s) / intervention(s)

QTORIN 3.9% rapamycin anhydrous gel

QTORIN 3.9% rapamycin anhydrous gel: QTORIN 3.9% Rapamycin Anhydrous Gel

Study summary

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

Eligibility

Sex
ALL
Min age
6 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: The participant must have a clinically confirmed superficial/ cutaneous (visible on the skin) venous malformation (cVM), referred to as the treatment area. The treatment area may contain a minority (\<30%) lymphatic component (mixed venous / lymphatic malformation). \- Exclusion Criteria: * 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.

Primary outcome measure(s)

Trial sites (10)

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

More Palvella Therapeutics, Inc. trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06653842 on ClinicalTrials.gov ↗ ← All trials in the USA