Evaluating a new gel treatment for 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
This study is testing a new gel treatment for people aged 6 and older with microcystic lymphatic malformations to see if it can improve their condition over 24 weeks.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 6 Years and up |
| Sex | All |
| Sponsor | Palvella Therapeutics, Inc. Industry-sponsored |
| Locations | 15 sites (Irvine, California and 14 other locations) |
| Trial ID | NCT06239480 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of QTORIN 3.9% Rapamycin Anhydrous Gel in treating microcystic lymphatic malformations over a 24-week period. Approximately 40 participants aged 6 years and older with confirmed superficial microcystic lymphatic malformations will be enrolled. The study will assess changes in the condition using a baseline-controlled approach, with an option for participants to continue treatment beyond 24 weeks. The primary outcome will focus on the improvement of the condition as measured by the Investigator's Global Assessment (IGA).
Who should consider this trial
Good fit: Ideal candidates are children and adolescents aged 6 years and older with clinically confirmed superficial microcystic lymphatic malformations.
Not a fit: Patients with complicated vascular anomalies requiring systemic therapy or those with treatment areas in wet mucosa or within the orbital rim may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a non-invasive option for managing microcystic lymphatic malformations in patients.
How similar studies have performed: Other studies have explored topical treatments for vascular malformations, but this specific approach with QTORIN gel is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * Participant must be at least 6 years of age at time of consent * Participant must have a clinically confirmed superficial/cutaneous microcystic lymphatic malformation Key Exclusion Criteria: * Participants who have vascular malformations that interfere with evaluating the target microcystic lymphatic malformation * 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
Where this trial is running
Irvine, California and 14 other locations
- Children's Hospital of Orange County — Irvine, California, United States (Recruiting)
- Stanford University — Palo Alto, California, United States (Recruiting)
- Children's Healthcare of Atlanta — Atlanta, Georgia, United States (Recruiting)
- Minnesota Clinical Study Center — New Brighton, Minnesota, United States (Recruiting)
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
- Vascular Birthmark Institute — New York, New York, United States (Recruiting)
- University of North Carolina — Chapel Hill, North Carolina, United States (Recruiting)
- Cincinnati Children's Hospital — Cincinnati, Ohio, United States (Recruiting)
- Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
- Penn State Hershey Medical Center — Hershey, Pennsylvania, United States (Recruiting)
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
- Vanderbilt Children's Hospital — Nashville, Tennessee, United States (Recruiting)
- University of Texas, Dell Children's — Austin, Texas, United States (Not_yet_recruiting)
- Texas Children's Hospital — Houston, Texas, United States (Recruiting)
- University of Utah Health — Salt Lake City, Utah, United States (Recruiting)
Study contacts
- Principal investigator: Joyce Teng — Stanford University
- Study coordinator: Emily Cook
- Email: emily.cook@palvellatx.com
- Phone: 267-738-6366
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.