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SELVA: A Phase 3 Study Evaluating QTORIN 3.9% Rapamycin Anhydrous Gel in the Treatment of Microcystic Lymphatic Malformations
Sponsor: Palvella Therapeutics, Inc.
Summary
SELVA: A Multicenter, Phase 3 Baseline-Controlled Study Evaluating the Safety and Efficacy of QTORIN 3.9% Rapamycin Anhydrous Gel in the Treatment of Microcystic Lymphatic Malformations The main purpose of this study is to assess the change in microcystic lymphatic malformations IGA after 24 weeks of treatment with QTORIN 3.9% Rapamycin Anhydrous Gel in approximately 40 participants with microcystic lymphatic malformations. Efficacy will be evaluated at 24 weeks and patients have the option of continuing on treatment for \>24 weeks.
Official title: SELVA: A Multicenter, Phase 3 Baseline-Controlled Study Evaluating the Safety and Efficacy of QTORIN 3.9% Rapamycin Anhydrous Gel in the Treatment of Microcystic Lymphatic Malformations
Key Details
Gender
All
Age Range
3 Years - Any
Study Type
INTERVENTIONAL
Enrollment
51
Start Date
2024-07-31
Completion Date
2026-07
Last Updated
2026-03-27
Healthy Volunteers
No
Conditions
Interventions
QTORIN 3.9% Rapamycin Anhydrous Gel
QTORIN 3.9% Rapamycin Anhydrous Gel
Locations (15)
Children's Hospital of Orange County
Irvine, California, United States
Stanford University
Palo Alto, California, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, 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
Vanderbilt Children's Hospital
Nashville, Tennessee, United States
University of Texas, Dell Children's
Austin, Texas, United States
Texas Children's Hospital
Houston, Texas, United States
University of Utah Health
Salt Lake City, Utah, United States