Clinical Trial

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

Study acronym: TOIVA
Active, Not Recruiting Phase 2
View on ClinicalTrials.gov →
Summary
A Phase 2, Baseline-Controlled Study Evaluating the Safety and Efficacy of PTX022 (sirolimus) Topical Gel 3.9% in the Treatment of Cutaneous Venous Malformations
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2024-10-21; most recent amendment 2026-03-26.
Status change: Recruiting → Active, Not Recruiting 2026-03-26
Status change: Not Yet Recruiting → Recruiting 2024-12-02
Trial Details
NCT Number NCT06653842
Lead Sponsor Palvella Therapeutics, Inc.
Conditions Cutaneous Venous Malformations
Enrollment 15 participants
Start Date 2024-12-20
Primary Completion 2025-11-21 (estimated)
Study Completion 2026-03 (estimated)
Updated on ClinicalTrials.gov 2026-03-27