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ACTIVE NOT RECRUITING
NCT06239480
PHASE3

SELVA: A Phase 3 Study Evaluating QTORIN 3.9% Rapamycin Anhydrous Gel in the Treatment of Microcystic Lymphatic Malformations

Sponsor: Palvella Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

SELVA: A Multicenter, Phase 3 Baseline-Controlled Study Evaluating the Safety and Efficacy of QTORIN 3.9% Rapamycin Anhydrous Gel in the Treatment of Microcystic Lymphatic Malformations The main purpose of this study is to assess the change in microcystic lymphatic malformations IGA after 24 weeks of treatment with QTORIN 3.9% Rapamycin Anhydrous Gel in approximately 40 participants with microcystic lymphatic malformations. Efficacy will be evaluated at 24 weeks and patients have the option of continuing on treatment for \>24 weeks.

Official title: SELVA: A Multicenter, Phase 3 Baseline-Controlled Study Evaluating the Safety and Efficacy of QTORIN 3.9% Rapamycin Anhydrous Gel in the Treatment of Microcystic Lymphatic Malformations

Key Details

Gender

All

Age Range

3 Years - Any

Study Type

INTERVENTIONAL

Enrollment

51

Start Date

2024-07-31

Completion Date

2026-07

Last Updated

2026-03-27

Healthy Volunteers

No

Interventions

DRUG

QTORIN 3.9% Rapamycin Anhydrous Gel

QTORIN 3.9% Rapamycin Anhydrous Gel

Locations (15)

Children's Hospital of Orange County

Irvine, California, United States

Stanford University

Palo Alto, California, United States

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Minnesota Clinical Study Center

New Brighton, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

Vascular Birthmark Institute

New York, New York, United States

University of North Carolina

Chapel Hill, North Carolina, United States

Cincinnati Children's Hospital

Cincinnati, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

Penn State Hershey Medical Center

Hershey, Pennsylvania, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Vanderbilt Children's Hospital

Nashville, Tennessee, United States

University of Texas, Dell Children's

Austin, Texas, United States

Texas Children's Hospital

Houston, Texas, United States

University of Utah Health

Salt Lake City, Utah, United States