Fact CheckerSign in

NCT06239480Active, not recruitingPhase 3

SELVA: A Phase 3 Study Evaluating 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

Source: ClinicalTrials.gov · Last updated 27 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
51 (actual)
First submitted
16 Jan 2024
Start date
31 Jul 2024
Primary completion date
14 Jan 2026
Lead sponsor
Palvella Therapeutics, Inc.
NCT number
NCT06239480

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 51
  • From 31 Jul 2024 to the primary completion date, 14 Jan 2026
  • 15 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participants with complicated vascular anomalies with severe systemic symptoms that require systemic therapy

Other

  • Participants who have vascular malformations that interfere with evaluating the target microcystic lymphatic malformation
  • 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

Who the study is looking for

  • 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

Age in the registry: 3 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (15)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Children's Healthcare of Atlanta
Coordinator of this site? Confirm its status
AtlantaUnited StatesUnknown status
University of Texas, Dell Children's
Coordinator of this site? Confirm its status
AustinUnited StatesUnknown status
University of North Carolina
Coordinator of this site? Confirm its status
Chapel HillUnited StatesUnknown status
Cincinnati Children's Hospital
Coordinator of this site? Confirm its status
CincinnatiUnited StatesUnknown status
Cleveland Clinic
Coordinator of this site? Confirm its status
ClevelandUnited StatesUnknown status
Penn State Hershey Medical Center
Coordinator of this site? Confirm its status
HersheyUnited StatesUnknown status
Texas Children's Hospital
Coordinator of this site? Confirm its status
HoustonUnited StatesUnknown status
Children's Hospital of Orange County
Coordinator of this site? Confirm its status
IrvineUnited StatesUnknown status
Vanderbilt Children's Hospital
Coordinator of this site? Confirm its status
NashvilleUnited StatesUnknown status
Minnesota Clinical Study Center
Coordinator of this site? Confirm its status
New BrightonUnited StatesUnknown status
Vascular Birthmark Institute
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
Stanford University
Coordinator of this site? Confirm its status
Palo AltoUnited StatesUnknown status
Children's Hospital of Philadelphia
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesUnknown status
Mayo Clinic
Coordinator of this site? Confirm its status
RochesterUnited StatesUnknown status
University Of Utah Health
Coordinator of this site? Confirm its status
Salt Lake CityUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.