RECRUITING

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

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Conditions

Microcystic Lymphatic MalformationLymphangioma circumscriptumLymphatic malformationVascular malformationTopicalSirolimusRapamycinCongenital malformationNon-infective disorder of lymphatic vessels and lymph nodes

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2024-07-31
Study Completion:2026-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06239480

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.

Ages Eligible for Study:6 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participant must be at least 6 years of age at time of consent
  2. * Participant must have a clinically confirmed superficial/cutaneous microcystic lymphatic malformation
  1. * Participants who have vascular malformations that interfere with evaluating the target microcystic lymphatic malformation
  2. * Participants with complicated vascular anomalies with severe systemic symptoms that require systemic therapy
  3. * The participant's treatment area is mainly in any wet mucosa or within the orbital rim
  4. * Participants who are pregnant or planning to become pregnant

Contacts and Locations

Study Contact

Emily Cook
CONTACT
267-738-6366
emily.cook@palvellatx.com

Principal Investigator

Joyce Teng
PRINCIPAL_INVESTIGATOR
Stanford University

Study Locations (Sites)

Stanford University
Palo Alto, California, 94305
United States
Children's Healthcare of Atlanta
Atlanta, Georgia, 30342
United States
Minnesota Clinical Study Center
New Brighton, Minnesota, 55112
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
Vascular Birthmark Institute
New York, New York, 10016
United States
University of North Carolina
Chapel Hill, North Carolina, 27516
United States
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Vanderbilt Children's Hospital
Nashville, Tennessee, 37232
United States
University of Texas, Dell Children's
Austin, Texas, 78723
United States
Texas Children's Hospital
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Palvella Therapeutics, Inc.

  • Joyce Teng, PRINCIPAL_INVESTIGATOR, Stanford University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-31
Study Completion Date2026-07

Study Record Updates

Study Start Date2024-07-31
Study Completion Date2026-07

Terms related to this study

Keywords Provided by Researchers

  • Lymphangioma circumscriptum
  • Lymphatic malformation
  • Vascular malformation
  • Topical
  • Sirolimus
  • Rapamycin
  • Congenital malformation
  • Non-infective disorder of lymphatic vessels and lymph nodes

Additional Relevant MeSH Terms

  • Microcystic Lymphatic Malformation