SELVA: A Phase 3 Study Evaluating QTORIN 3.9% Rapamycin Anhydrous Gel in the Treatment of Microcystic Lymphatic Malformations
NCT ID: NCT06239480
Last Updated: 2025-07-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
40 participants
INTERVENTIONAL
2024-07-31
2026-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Active
QTORIN 3.9% Rapamycin Anhydrous Gel
QTORIN 3.9% Rapamycin Anhydrous Gel
Interventions
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QTORIN 3.9% Rapamycin Anhydrous Gel
QTORIN 3.9% Rapamycin Anhydrous Gel
Eligibility Criteria
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Inclusion Criteria
* Participant must have a clinically confirmed superficial/cutaneous microcystic lymphatic malformation
Exclusion Criteria
* Participants with complicated vascular anomalies with severe systemic symptoms that require systemic therapy
* The participant's treatment area is mainly in any wet mucosa or within the orbital rim
* Participants who are pregnant or planning to become pregnant
3 Years
ALL
No
Sponsors
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FDA Office of Orphan Products Development
FED
Palvella Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Joyce Teng
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Study Coordinator
Role: primary
Study Coordiantor
Role: primary
Study Coordinator
Role: primary
Steve Kempers, MD, FAAD
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordiantor
Role: primary
Study Coordinator
Role: primary
Other Identifiers
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PALV-09
Identifier Type: -
Identifier Source: org_study_id
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