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
RECRUITINGStanford University
Palo Alto, California, United States
RECRUITINGIncidence 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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Colorado Children's Hospital
Aurora, Colorado, United States
RECRUITINGJohns Hopkins
Baltimore, Maryland, United States
RECRUITINGMinnesota Clinical Study Center
New Brighton, Minnesota, United States
RECRUITINGMayo Clinic
Rochester, Minnesota, United States
RECRUITINGUniversity of North Carolina
Chapel Hill, North Carolina, United States
RECRUITINGCleveland Clinic
Cleveland, Ohio, United States
RECRUITINGChildren's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
RECRUITINGUniversity of Utah Health
Salt Lake City, Utah, United States
RECRUITING