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NCT06653842 · ClinicalTrials.gov registry record · Phase 2

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 study of Cutaneous Venous Malformations, sponsored by Palvella Therapeutics.

Recruiting
Registry status
Phase 2
Development phase
15
Enrollment target
10
Study locations

NCT06653842: Recruiting Phase 2 study of Cutaneous Venous Malformations, sponsored by Palvella Therapeutics.

NCT06653842 is a Phase 2 study of Cutaneous Venous Malformations that is actively recruiting participants, run by Palvella Therapeutics. The registered enrollment target is 15 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). The trial reports 10 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06653842, a Phase 2 study of Cutaneous Venous Malformations, is actively recruiting participants, sponsored by Palvella Therapeutics.

RECRUITING
Registry status
Phase 2
Development phase
15 participants
Enrollment target
10
Study locations

Study Summary

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

Interventions

  • DRUG QTORIN 3.9% rapamycin anhydrous gel

Study Locations (10)

California

  • Children's Hospital of Orange County - Irvine
  • Stanford University - Palo Alto

Minnesota

  • Minnesota Clinical Study Center - New Brighton
  • Mayo Clinic - Rochester

Colorado

  • Colorado Children's Hospital - Aurora

Maryland

  • Johns Hopkins - Baltimore

North Carolina

  • University of North Carolina - Chapel Hill

Ohio

  • Cleveland Clinic - Cleveland

Pennsylvania

  • Children's Hospital of Philadelphia - Philadelphia

Utah

  • University of Utah Health - Salt Lake City

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2024-12-20
Est. Completion 2026-03
Phase Phase 2
Palvella Therapeutics

9 total trials

What NCT06653842 shows while recruiting

NCT06653842 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).

The record links to 1 condition, with Cutaneous Venous Malformations appearing as the primary indexed condition, and to 1 intervention - of which QTORIN 3.9% rapamycin anhydrous gel is the first listed.

NCT06653842 lists 10 locations in 8 states (California, Minnesota, Colorado).

Frequently Asked Questions

What is clinical trial NCT06653842 about?

NCT06653842 is a clinical study titled "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

What is the current status of trial NCT06653842?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2024-12-20. Estimated completion is 2026-03.

What conditions does trial NCT06653842 study?

This clinical trial studies the following conditions: Cutaneous Venous Malformations.

What interventions are being tested in trial NCT06653842?

The interventions under investigation include: QTORIN 3.9% rapamycin anhydrous gel (DRUG).

Who is sponsoring clinical trial NCT06653842?

This trial is sponsored by Palvella Therapeutics, which has 9 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06653842 being conducted?

This trial has 10 study locations across California, Colorado, Maryland, Minnesota, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT06653842's enrollment target sits among peer trials

15 1919th of 2000 higher than 60 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06653842, the US trial registry maintained by the National Library of Medicine. NCT06653842 (small enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.