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

March 26, 2026 updated by: Palvella Therapeutics, Inc.

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 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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Irvine, California, United States, 92612
        • Children's Hospital of Orange County
      • Palo Alto, California, United States, 94305
        • Stanford University
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Children's Healthcare of Atlanta
    • Minnesota
      • New Brighton, Minnesota, United States, 55112
        • Minnesota Clinical Study Center
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • New York
      • New York, New York, United States, 10016
        • Vascular Birthmark Institute
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27516
        • University of North Carolina
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Hershey Medical Center
      • Philadelphia, Pennsylvania, United States, 19104
        • Children's Hospital of Philadelphia
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt Children's Hospital
    • Texas
      • Austin, Texas, United States, 78723
        • University of Texas, Dell Children's
      • Houston, Texas, United States, 77030
        • Texas Children's Hospital
    • Utah
      • Salt Lake City, Utah, United States, 84113
        • University of Utah Health

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.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • Participant must be at least 3 years of age at time of consent/assent
  • Participant must have a clinically confirmed superficial/cutaneous microcystic lymphatic malformation

Key Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active
Drug: QTORIN 3.9% Rapamycin Anhydrous Gel
QTORIN 3.9% Rapamycin Anhydrous Gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall microcystic lymphatic malformations Investigator Global Assessment (mLM-IGA)
Time Frame: At Week 24
A multi-point scale with higher values indicating improvement.
At Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence and severity of adverse events
Time Frame: From Baseline to Week 24
From Baseline to Week 24
Change in the blinded clinician microcystic lymphatic malformations Multicomponent Severity Scale (mLM-MCSS)
Time Frame: At Week 24
A multi-point scale with lower values indicating improvement.
At Week 24
Change in the live clinician microcystic lymphatic malformations Multicomponent Severity Scale (mLM-MCSS)
Time Frame: Change from Baseline to Week 24
A multi-point scale with lower values indicating improvement.
Change from Baseline to Week 24
Overall patient global impression of change (PGI-C)
Time Frame: Change from Baseline to Week 24
A multi-point scale with lower values indicating improvement.
Change from Baseline to Week 24
Change in Overall Clinician Global Impression of Severity (CGI-S)
Time Frame: Change from Baseline to Week 24
A multi-point scale with lower values indicating improvement.
Change from Baseline to Week 24
Change in Overall Patient Global Impression of Severity (PGI-S)
Time Frame: Change from Baseline to Week 24
A multi-point scale with lower values indicating improvement.
Change from Baseline to Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Palvella Therapeutics, Inc.

Collaborators

FDA Office of Orphan Products Development

Investigators

  • Principal Investigator: Joyce Teng, 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 Major Dates

Study Start (Actual)

July 31, 2024

Primary Completion (Actual)

January 14, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

January 16, 2024

First Submitted That Met QC Criteria

January 25, 2024

First Posted (Actual)

February 2, 2024

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 26, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PALV-09

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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