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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
QTORIN 3.9% Rapamycin Anhydrous Gel
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
Incidence of Treatment-Emergent Adverse Events
Time frame: Week 12
Change in Investigator Global Assessment (cVM-IGA) From Baseline to Week 12
Likert scale used by clinicians to evaluate the overall change of the study designated venous malformation
Time frame: Change from baseline to Week 12
Overall Patient Global Impression of Change (PGI-C) From Baseline to Week 12
Likert scale used by patients to evaluate the overall change of the study designated venous malformation
Time frame: Change from baseline to Week 12
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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