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

NCT ID: NCT06653842

Last Updated: 2025-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-20

Study Completion Date

2026-03-31

Brief Summary

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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

Detailed Description

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Conditions

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Cutaneous Venous Malformations

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single-arm, open-label

Group Type EXPERIMENTAL

QTORIN 3.9% rapamycin anhydrous gel

Intervention Type DRUG

QTORIN 3.9% Rapamycin Anhydrous Gel

Interventions

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QTORIN 3.9% rapamycin anhydrous gel

QTORIN 3.9% Rapamycin Anhydrous Gel

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\-

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.
Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Palvella Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Children's Hospital of Orange County

Irvine, California, United States

Site Status RECRUITING

Stanford University

Palo Alto, California, United States

Site Status RECRUITING

Colorado Children's Hospital

Aurora, Colorado, United States

Site Status RECRUITING

Johns Hopkins

Baltimore, Maryland, United States

Site Status RECRUITING

Minnesota Clinical Study Center

New Brighton, Minnesota, United States

Site Status RECRUITING

Mayo Clinic

Rochester, Minnesota, United States

Site Status RECRUITING

University of North Carolina

Chapel Hill, North Carolina, United States

Site Status RECRUITING

Cleveland Clinic

Cleveland, Ohio, United States

Site Status RECRUITING

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

University of Utah Health

Salt Lake City, Utah, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Emily Cook

Role: CONTACT

267-738-6366

Facility Contacts

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Study Coordinator

Role: primary

Related Links

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Other Identifiers

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PALV-10

Identifier Type: -

Identifier Source: org_study_id

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