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

Description

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.

Conditions

Microcystic Lymphatic Malformation

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Microcystic Lymphatic Malformation
Intervention / Treatment

-

Contacts and Locations

Palo Alto

Stanford University, Palo Alto, California, United States, 94305

Atlanta

Children's Healthcare of Atlanta, Atlanta, Georgia, United States, 30342

New Brighton

Minnesota Clinical Study Center, New Brighton, Minnesota, United States, 55112

Rochester

Mayo Clinic, Rochester, Minnesota, United States, 55905

New York

Vascular Birthmark Institute, New York, New York, United States, 10016

Chapel Hill

University of North Carolina, Chapel Hill, North Carolina, United States, 27516

Cincinnati

Cincinnati Children's Hospital, Cincinnati, Ohio, United States, 45229

Cleveland

Cleveland Clinic, Cleveland, Ohio, United States, 44195

Hershey

Penn State Hershey Medical Center, Hershey, Pennsylvania, United States, 17033

Philadelphia

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States, 19104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Participant must be at least 6 years of age at time of consent
  • * Participant must have a clinically confirmed superficial/cutaneous microcystic lymphatic malformation
  • * 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

Ages Eligible for Study

6 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Palvella Therapeutics, Inc.,

Joyce Teng, PRINCIPAL_INVESTIGATOR, Stanford University

Study Record Dates

2026-07