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OpenTrials
Active, Not Recruiting

NCT Number: NCT06653842

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Cutaneous Venous Malformations

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Children's Hospital of Orange County, Irvine, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

The participant must have a clinically confirmed superficial/ cutaneous (visible on the skin) venous malformation (cVM), referred to as the treatment area. The treatment area may contain a minority (<30%) lymphatic component (mixed venous / lymphatic malformation).

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Exclusion criteria

  • The participant's treatment area is mainly in any wet mucosa or within the orbital rim. For clarification, no part of the venous malformation should be evaluated or treated if it in mucosa. External genital presentation is permitted.
  • The participant has a known pervasive extension of the lesion into mucosa, bone or tissue (as determined by diagnostic or the investigator) that would impair the ability of the investigator to evaluate the cutaneous components of the lesion.

Treatment and study plan

QTORIN 3.9% rapamycin anhydrous gel

Drug

QTORIN 3.9% Rapamycin Anhydrous Gel

Primary outcomes

  1. Incidence of Treatment-Emergent Adverse Events

    Time frame: Week 12

Secondary outcomes

  1. Change in Investigator Global Assessment (cVM-IGA) From Baseline to Week 12

    Time frame: Change from baseline to Week 12

    Likert scale used by clinicians to evaluate the overall change of the study designated venous malformation

  2. Overall Patient Global Impression of Change (PGI-C) From Baseline to Week 12

    Time frame: Change from baseline to Week 12

    Likert scale used by patients to evaluate the overall change of the study designated venous malformation

Sponsors and collaborators

Lead sponsor

Palvella Therapeutics, Inc.

Industry

Registry information

Acronym: TOIVA

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Oct 22, 2024
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.