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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: Recruiting Phase 3 study of Microcystic Lymphatic Malformation, sponsored by Palvella Therapeutics.
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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower). The trial reports 15 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
A multi-point scale with higher values indicating improvement.
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 |
What NCT06239480 shows while recruiting
NCT06239480 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower).
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 lists 15 locations in 10 states (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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06239480's enrollment target sits among peer trials
40 1879th of 2000 higher than 103 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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