Clinical Trial

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

Study acronym: SELVA
Active, Not Recruiting Phase 3
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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.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2024-01-25; most recent amendment 2026-03-26.
Status change: Recruiting → Active, Not Recruiting 2026-03-26
Status change: Not Yet Recruiting → Recruiting 2024-06-26
Trial Details
NCT Number NCT06239480
Lead Sponsor Palvella Therapeutics, Inc.
Collaborators: FDA Office of Orphan Products Development
Conditions Microcystic Lymphatic Malformation
Enrollment 51 participants
Start Date 2024-07-31
Primary Completion 2026-01-14 (estimated)
Study Completion 2026-07 (estimated)
Updated on ClinicalTrials.gov 2026-03-27