A Phase 2, Baseline-Controlled Study Evaluating the Safety and Efficacy of PTX-022 (Sirolimus) Topical Gel 3.9% in the Treatment of Cutaneous Venous Malformations
NCT ID: NCT06653842
Last Updated: 2025-08-12
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
PHASE2
15 participants
INTERVENTIONAL
2024-12-20
2026-03-31
Brief Summary
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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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Single-arm, open-label
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
Exclusion Criteria
* The participant has a known pervasive extension of the lesion into mucosa, bone or tissue (as determined by diagnostic or the investigator) that would impair the ability of the investigator to evaluate the cutaneous components of the lesion.
6 Years
ALL
No
Sponsors
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Palvella Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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Children's Hospital of Orange County
Irvine, California, United States
Stanford University
Palo Alto, California, United States
Colorado Children's Hospital
Aurora, Colorado, United States
Johns Hopkins
Baltimore, Maryland, United States
Minnesota Clinical Study Center
New Brighton, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 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
Related Links
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Related Info
Other Identifiers
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PALV-10
Identifier Type: -
Identifier Source: org_study_id
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