NCT06239480Active, not recruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 27 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 51 (actual)
- First submitted
- 16 Jan 2024
- Start date
- 31 Jul 2024
- Primary completion date
- 14 Jan 2026
- Lead sponsor
- Palvella Therapeutics, Inc.
- NCT number
- NCT06239480
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 51
- From 31 Jul 2024 to the primary completion date, 14 Jan 2026
- 15 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants with complicated vascular anomalies with severe systemic symptoms that require systemic therapy
Other
- Participants who have vascular malformations that interfere with evaluating the target microcystic lymphatic malformation
- 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
Who the study is looking for
- Participant must be at least 3 years of age at time of consent/assent
- Participant must have a clinically confirmed superficial/cutaneous microcystic lymphatic malformation
Age in the registry: 3 years to - · Sex: All · Does not accept healthy volunteers
Sites (15)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Children's Healthcare of Atlanta Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| University of Texas, Dell Children's Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| University of North Carolina Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
| Cincinnati Children's Hospital Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Penn State Hershey Medical Center Coordinator of this site? Confirm its status | Hershey | United States | Unknown status |
| Texas Children's Hospital Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Children's Hospital of Orange County Coordinator of this site? Confirm its status | Irvine | United States | Unknown status |
| Vanderbilt Children's Hospital Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Minnesota Clinical Study Center Coordinator of this site? Confirm its status | New Brighton | United States | Unknown status |
| Vascular Birthmark Institute Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Stanford University Coordinator of this site? Confirm its status | Palo Alto | United States | Unknown status |
| Children's Hospital of Philadelphia Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Mayo Clinic Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| University Of Utah Health Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.