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New gel could treat painful skin vein bumps

NCT ID NCT06653842

Disease control Sponsor: Palvella Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tests a gel containing sirolimus (PTX-022) on 15 people with visible venous malformations on the skin. The goal is to see if the gel is safe and can improve the appearance and symptoms of these abnormal veins. Participants apply the gel daily for 12 weeks, and doctors track changes and side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Sirolimus topical gel 3.9%
What this could lead to
If it works, this could offer a non-invasive topical treatment option for visible venous malformations on the skin.
What could go wrong
This is a small, early-phase trial with only 15 participants and no control group, so results may not be conclusive. Side effects from sirolimus gel are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 15 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Mar 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

multiple cutaneous and mucosal venous malformations venous hemangioma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cutaneous venous malformations

Contacts and locations

Locations

  • Children's Hospital of Orange County

    Irvine, California, 92612, United States

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Colorado Children's Hospital

    Aurora, Colorado, 80045, United States

  • Johns Hopkins

    Baltimore, Maryland, 21287, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Minnesota Clinical Study Center

    New Brighton, Minnesota, 55112, United States

  • Stanford University

    Palo Alto, California, 94305, United States

  • University of North Carolina

    Chapel Hill, North Carolina, 27516, United States

  • University of Utah Health

    Salt Lake City, Utah, 84113, United States