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
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)
Incidence of Treatment-Emergent Adverse Events — Week 12
Trial sites (10)
Facility
City
Region
Status
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
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.
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