Evaluating a topical gel for treating skin venous malformations
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
This study is testing a new gel for treating skin venous malformations to see if it helps improve the condition safely.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 6 Years and up |
| Sex | All |
| Sponsor | Palvella Therapeutics, Inc. Industry-sponsored |
| Locations | 10 sites (Irvine, California and 9 other locations) |
| Trial ID | NCT06653842 on ClinicalTrials.gov |
What this trial studies
This Phase 2 clinical trial assesses the safety and efficacy of a 3.9% topical gel containing sirolimus for patients with cutaneous venous malformations. Participants will apply the gel to the affected area, which may include a minor lymphatic component. The study is baseline-controlled, meaning it will compare results against a baseline measurement to evaluate the gel's effectiveness. The trial aims to gather data on how well the treatment works and its safety profile.
Who should consider this trial
Good fit: Ideal candidates are individuals with clinically confirmed superficial cutaneous venous malformations visible on the skin.
Not a fit: Patients with lesions primarily located in wet mucosa or those with extensive involvement of deeper tissues may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could provide a non-invasive option for patients suffering from cutaneous venous malformations.
How similar studies have performed: While this approach is novel, similar studies evaluating topical treatments for vascular malformations have shown promise.
Eligibility criteria
Show full inclusion / exclusion criteria
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). - 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.
Where this trial is running
Irvine, California and 9 other locations
- Children's Hospital of Orange County — Irvine, California, United States (Not_yet_recruiting)
- Stanford University — Palo Alto, California, United States (Not_yet_recruiting)
- Colorado Children's Hospital — Aurora, Colorado, United States (Not_yet_recruiting)
- John's Hopkins — Baltimore, Maryland, United States (Not_yet_recruiting)
- Minnesota Clinical Study Center — New Brighton, Minnesota, United States (Recruiting)
- Mayo Clinic — Rochester, Minnesota, United States (Not_yet_recruiting)
- University of North Carolina — Chapel Hill, North Carolina, United States (Not_yet_recruiting)
- Cleveland Clinic — Cleveland, Ohio, United States (Not_yet_recruiting)
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Not_yet_recruiting)
- University of Utah Health — Salt Lake City, Utah, United States (Not_yet_recruiting)
Study contacts
- Study coordinator: Emily Cook
- Email: emily.cook@palvellatx.com
- Phone: 267-738-6366
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.