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Brief Title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study Evaluating Safety and Efficacy of QTORIN 3.9% Rapamycin Anhydrous Gel in the Treatment of Microcystic Lymphatic Malformations
Official Title: A Multicenter, Phase 3 Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of QTORIN 3.9% Rapamycin Anhydrous Gel in the Treatment of Microcystic Lymphatic Malformations
Study ID: NCT06239480
Brief Summary: The main purpose of this study is to assess the change in clinician global impression after 24 weeks of treatment with QTORIN 3.9% Rapamycin Anhydrous Gel compared to placebo in approximately 50 participants with microcystic lymphatic malformations.
Detailed Description:
Minimum Age: 6 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Stanford University, Palo Alto, California, United States
University of Iowa, Iowa City, Iowa, United States
Minnesota Clinical Study Center, New Brighton, Minnesota, United States
Mayo Clinic, Rochester, Minnesota, United States
Vascular Birthmark Institute, New York, New York, United States
University of North Carolina, Chapel Hill, North Carolina, United States
Cincinnati Children's Hospital, Cincinnati, Ohio, United States
Cleveland Clinic, Cleveland, Ohio, United States
Penn State Hershey Medical Center, Hershey, Pennsylvania, United States
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
Texas Children's Hospital, Houston, Texas, United States
Name: Joyce Teng
Affiliation: Stanford University
Role: PRINCIPAL_INVESTIGATOR