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Clinical Trials in the USA / NCT06239480
Active, not recruiting Phase 3

SELVA: A Phase 3 Study Evaluating QTORIN 3.9% Rapamycin Anhydrous Gel in the Treatment of Microcystic Lymphatic Malformations

NCT06239480 · tracked via the Priya Life Science USA tracker
Sponsor
Palvella Therapeutics, Inc
Phase
Phase 3
Started
2024-07-31
Last updated
2026-03-27

Condition(s) studied

Microcystic Lymphatic Malformation

Investigational drug(s) / intervention(s)

QTORIN 3.9% Rapamycin Anhydrous Gel →

QTORIN 3.9% Rapamycin Anhydrous Gel: QTORIN 3.9% Rapamycin Anhydrous Gel

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.

Eligibility

Sex
ALL
Min age
3 Years
Max age
—
Healthy volunteers
No
Key Inclusion Criteria: * 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 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

Primary outcome measure(s)

  • Overall microcystic lymphatic malformations Investigator Global Assessment (mLM-IGA) — At Week 24
    A multi-point scale with higher values indicating improvement.

Trial sites (15)

FacilityCityRegionStatus
Children's Hospital of Orange County Irvine California
Stanford University Palo Alto California
Children's Healthcare of Atlanta Atlanta Georgia
Minnesota Clinical Study Center New Brighton Minnesota
Mayo Clinic Rochester Minnesota
Vascular Birthmark Institute New York New York
University of North Carolina Chapel Hill North Carolina
Cincinnati Children's Hospital Cincinnati Ohio
Cleveland Clinic Cleveland Ohio
Penn State Hershey Medical Center Hershey Pennsylvania
Children's Hospital of Philadelphia Philadelphia Pennsylvania
Vanderbilt Children's Hospital Nashville Tennessee
University of Texas, Dell Children's Austin Texas
Texas Children's Hospital Houston Texas
University of Utah Health Salt Lake City Utah

More Palvella Therapeutics, Inc. trials in the USA

A Study Evaluating the Safety and Pharmacokinetics of QTORIN Rapamycin 3.9% Anhydrous Gel in the Treatment of Adults With Pachyonychia Congenita Recruiting
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 Active, not recruiting
A Phase 2, Baseline-Controlled Study Evaluating the Safety and Efficacy of PTX-022 (Sirolimus) Topical Gel 3.9% in the Treatment of Angiokeratomas (LOTU) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06239480 on ClinicalTrials.gov ↗ ← All trials in the USA