This study is in progress, not accepting new patients

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

a study on Microcystic Lymphatic Malformation

Summary

Eligibility
for people ages 3 years and up (full criteria)
Location
at UC Irvine
Dates
study started
study ends around
Principal Investigator
by Maria Buethe (uci)

Description

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

Keywords

Microcystic Lymphatic Malformation, Lymphangioma circumscriptum, Lymphatic malformation, Vascular malformation, Topical, Sirolimus, Rapamycin, Congenital malformation, Non-infective disorder of lymphatic vessels and lymph nodes, Lymphangioma, Lymphatic Abnormalities, Vascular Malformations, Congenital Abnormalities, QTORIN 3.9% Rapamycin Anhydrous Gel

Eligibility

You can join if…

Open to people ages 3 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • Children's Hospital of Orange County
    Irvine California 92612 United States
  • Stanford University
    Palo Alto California 94305 United States

Lead Scientist at University of California Health

  • Maria Buethe (uci)
    Assistant Health Sciences Professor, Dermatology, School of Medicine. Authored (or co-authored) 26 research publications

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Palvella Therapeutics, Inc.
ID
NCT06239480
Phase
Phase 3 Microcystic Lymphatic Malformation Research Study
Study Type
Interventional
Participants
About 51 people participating
Last Updated