SELVA: A Phase 3 Study Evaluating QTORIN 3.9% Rapamycin Anhydrous Gel in the Treatment of Microcystic Lymphatic Malformations
Running, not enrolling · Phase 3
Conditions studied: Microcystic Lymphatic Malformation
In brief
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.
Key facts
- Study ID
- NCT06239480
- Run by
- Palvella Therapeutics, Inc.
- People needed
- 51
- Starts
- 2024-07-31
- Expected to finish
- 2026-07-01
- Last updated by the study team
- 2026-03-27
Who can join
Age: 3 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- 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
Full record on ClinicalTrials.gov
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