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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
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date changed from estimate of Dec 2025 to Nov 21, 2025
    • Site details revised at 10 of 10 sites
    v6
  2. Minor Study sites revised (10)v5
  3. Minor Site details revised at 8 of 10 sitesv4
  4. Minor Study sites: 4 to 10
    • Start date changed from estimate of Dec 2024 to Dec 20, 2024
    v3
  5. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 5 more changesShow less
    • Primary endpoint revised
    • Enrollment target: 20 to 15
    • Study sites: 0 to 4
    • Study completion date: Jan 2026 to Mar 2026
    • Secondary endpoints expanded, about 23 words
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT06653842
Lead Sponsor Palvella Therapeutics, Inc.
Conditions
(from sponsor)
Cutaneous Venous Malformations
Enrollment 15 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov