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Completed Phase 2 Interventional Results available

Study Evaluating the Safety and Efficacy of PTX-022 (QTORIN Sirolimus) in the Treatment of Microcystic Lymphatic Malformations

ClinicalTrials.gov ID: NCT05050149

Public ClinicalTrials.gov record NCT05050149. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 22, 2026, 4:48 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Multicenter, Phase 2, Open-Label Study Evaluating The Safety And Efficacy of Sirolimus 3.9% Topical Gel (PTX-022) In The Treatment of Microcystic Lymphatic Malformations

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This study evaluates the safety and efficacy of PTX-022 (sirolimus) Topical Gel 3.9% w/w in the treatment of Microcystic Lymphatic Malformations. The participant will receive 3 months of PTX-022 treatment by the end of the study.

Study identification

NCT ID
NCT05050149
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Palvella Therapeutics, Inc.
Industry
Enrollment
12 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
6 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 13, 2022 (Actual)
Primary completion
Nov 15, 2022 (Actual)
Completion
Dec 15, 2022 (Actual)
Last update posted
Jan 17, 2025

2022

United States locations

U.S. sites
7
U.S. states
7
U.S. cities
7
Facility City State ZIP Site status
Arkansas Children's Hospital Little Rock Arkansas 72202 —
Stanford University Palo Alto California 94305 —
Minnesota Clinical Study Center Fridley Minnesota 55432 —
Vascular Birthmark Institute New York New York 10065 —
Cincinnati Children's Hospital Cincinnati Ohio 45229 —
Oregon Health and Science University Portland Oregon 97239 —
Children's Hospital of Pennsylvania (CHOP) Philadelphia Pennsylvania 19104 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05050149, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 17, 2025 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05050149 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →