NCT06239480

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Palvella Therapeutics, Inc. · Industry
• Sex: All
• Age: 3 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Microcystic Lymphatic Malformation

Interventions

Type	Name	Description
DRUG	QTORIN 3.9% Rapamycin Anhydrous Gel	QTORIN 3.9% Rapamycin Anhydrous Gel

Timeline

• Start date: 2024-07-31
• Primary completion: 2026-01-14
• Completion: 2026-07-01
• First posted: 2024-02-02
• Last updated: 2026-03-27

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated drug study