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New gel could shrink rare skin bumps in kids and adults

NCT ID NCT06239480

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 3 trial is testing a gel containing rapamycin (QTORIN 3.9%) for people aged 3 and older with microcystic lymphatic malformations, a rare condition causing fluid-filled bumps on the skin. About 40 participants will apply the gel daily for 24 weeks to see if it improves the appearance and severity of the bumps. The study is currently active but not recruiting, and participants may continue treatment beyond 24 weeks.

What this could mean

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

Active substance
QTORIN 3.9% rapamycin anhydrous gel (a topical medication applied to the skin)
What this could lead to
If successful, this gel could offer a non-invasive treatment option to reduce the size and severity of microcystic lymphatic malformations, potentially improving symptoms and quality of life.
What could go wrong
This is a small, early-phase 3 study with only 51 participants, so results may not apply to everyone. The gel may cause skin irritation or not work for all types of lymphatic malformations.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

51 people

The number who actually took part.

Started

Jul 2024

Expected to finish

Jul 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

3 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.

Key Inclusion Criteria: * Participant must be at least 3 years of age at time of consent/assent * Participant must have a clinically confirmed superficial/cutaneous microcystic lymphatic malformation Key Exclusion Criteria: * Participants who have vascular malformations that interfere with evaluating the target microcystic lymphatic malformation * Participants with complicated vascular anomalies with severe systemic symptoms that require systemic therapy * The participant's treatment area is mainly in any wet mucosa or within the orbital rim * Participants who are pregnant or planning to become pregnant

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Conditions

The condition(s) this trial relates to.

Congenital Abnormalities lymphangioma Lymphatic Abnormalities microcystic lymphatic malformation vascular malformation

As listed by the trial registrant

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

Microcystic lymphatic malformation

Contacts and locations

Locations

  • Children's Healthcare of Atlanta

    Atlanta, Georgia, 30342, United States

  • Children's Hospital of Orange County

    Irvine, California, 92612, United States

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • Cincinnati Children's Hospital

    Cincinnati, Ohio, 45229, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Minnesota Clinical Study Center

    New Brighton, Minnesota, 55112, United States

  • Penn State Hershey Medical Center

    Hershey, Pennsylvania, 17033, United States

  • Stanford University

    Palo Alto, California, 94305, United States

  • Texas Children's Hospital

    Houston, Texas, 77030, United States

  • University of North Carolina

    Chapel Hill, North Carolina, 27516, United States

  • University of Texas, Dell Children's

    Austin, Texas, 78723, United States

  • University of Utah Health

    Salt Lake City, Utah, 84113, United States

  • Vanderbilt Children's Hospital

    Nashville, Tennessee, 37232, United States

  • Vascular Birthmark Institute

    New York, New York, 10016, United States

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