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

RECRUITINGPhase 3Sponsored by Palvella Therapeutics, Inc.
Actively Recruiting
PhasePhase 3
SponsorPalvella Therapeutics, Inc.
Started2024-07-31
Est. completion2026-01
Eligibility
Age3 Years+
Healthy vol.Accepted
Locations15 sites
View on ClinicalTrials.gov →

NCT06239480

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

Age: 3 Years+Healthy volunteers accepted
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

Conditions2

CancerMicrocystic Lymphatic Malformation

Locations15 sites

Children's Hospital of Orange County
Irvine, California, 92612
Study Coordinator
Stanford University
Palo Alto, California, 94305
Study Coordiantor
Children's Healthcare of Atlanta
Atlanta, Georgia, 30342
Study Coordinator
Minnesota Clinical Study Center
New Brighton, Minnesota, 55112
Steve Kempers, MD, FAAD
Mayo Clinic
Rochester, Minnesota, 55905
Study Coordinator

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