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NCT06239480 · ClinicalTrials.gov registry record · Phase 3
SELVA: A Phase 3 Study Evaluating QTORIN 3.9% Rapamycin Anhydrous Gel in the Treatment of Microcystic Lymphatic Malformations
A Phase 3 study of Microcystic Lymphatic Malformation, sponsored by Palvella Therapeutics.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 40
- Enrollment target
- 15
- Study locations
NCT06239480 is a Phase 3 study of Microcystic Lymphatic Malformation that is actively recruiting participants, run by Palvella Therapeutics. The registered enrollment target is 40 participants. The trial reports 15 study locations across 10 states.
The verdict
NCT06239480, a Phase 3 study of Microcystic Lymphatic Malformation, is actively recruiting participants, sponsored by Palvella Therapeutics.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 40 participants
- Enrollment target
- 15
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG QTORIN 3.9% Rapamycin Anhydrous Gel
Study Locations (15)
California
- Children's Hospital of Orange County - Irvine
- Stanford University - Palo Alto
Minnesota
- Minnesota Clinical Study Center - New Brighton
- Mayo Clinic - Rochester
Ohio
- Cincinnati Children's Hospital - Cincinnati
- Cleveland Clinic - Cleveland
Pennsylvania
- Penn State Hershey Medical Center - Hershey
- Children's Hospital of Philadelphia - Philadelphia
Texas
- University of Texas, Dell Children's - Austin
- Texas Children's Hospital - Houston
Georgia
- Children's Healthcare of Atlanta - Atlanta
New York
- Vascular Birthmark Institute - New York
North Carolina
- University of North Carolina - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2024-07-31 |
| Est. Completion | 2026-07 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06239480
The ClinicalTrials.gov registry entry for NCT06239480 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Palvella Therapeutics, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Microcystic Lymphatic Malformation appearing as the primary indexed condition, and to 1 intervention - of which QTORIN 3.9% Rapamycin Anhydrous Gel is the first listed.
NCT06239480 reports 15 study locations spanning 10 distinct geographic areas - top geographies include California, Minnesota, Ohio.
Frequently Asked Questions
What is clinical trial NCT06239480 about?
NCT06239480 is a clinical study titled "SELVA: A Phase 3 Study Evaluating QTORIN 3.9% Rapamycin Anhydrous Gel in the Treatment of Microcystic Lymphatic Malformations". 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 ...
What is the current status of trial NCT06239480?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 40 participants. The study started on 2024-07-31. Estimated completion is 2026-07.
What conditions does trial NCT06239480 study?
This clinical trial studies the following conditions: Microcystic Lymphatic Malformation.
What interventions are being tested in trial NCT06239480?
The interventions under investigation include: QTORIN 3.9% Rapamycin Anhydrous Gel (DRUG).
Who is sponsoring clinical trial NCT06239480?
This trial is sponsored by Palvella Therapeutics, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06239480 being conducted?
This trial has 15 study locations across California, Georgia, Minnesota, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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