Trial Title:
SELVA: A Phase 3 Study Evaluating QTORIN 3.9% Rapamycin Anhydrous Gel in the Treatment of Microcystic Lymphatic Malformations
NCT ID:
NCT06239480
Condition:
Microcystic Lymphatic Malformation
Conditions: Official terms:
Lymphangioma
Lymphatic Abnormalities
Congenital Abnormalities
Sirolimus
Conditions: Keywords:
Lymphangioma circumscriptum
Lymphatic malformation
Vascular malformation
Topical
Sirolimus
Rapamycin
Congenital malformation
Non-infective disorder of lymphatic vessels and lymph nodes
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
QTORIN 3.9% Rapamycin Anhydrous Gel
Description:
QTORIN 3.9% Rapamycin Anhydrous Gel
Arm group label:
Active
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.
Criteria for eligibility:
Criteria:
Key Inclusion 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
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
Gender:
All
Minimum age:
6 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Stanford University
Address:
City:
Palo Alto
Zip:
94305
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordiantor
Facility:
Name:
Minnesota Clinical Study Center
Address:
City:
New Brighton
Zip:
55112
Country:
United States
Status:
Recruiting
Contact:
Last name:
Steve Kempers, MD, FAAD
Facility:
Name:
Mayo Clinic
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Facility:
Name:
Vascular Birthmark Institute
Address:
City:
New York
Zip:
10016
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Facility:
Name:
University of North Carolina
Address:
City:
Chapel Hill
Zip:
27516
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Study Coordinator
Facility:
Name:
Cincinnati Children's Hospital
Address:
City:
Cincinnati
Zip:
45229
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Study Coordinator
Facility:
Name:
Cleveland Clinic
Address:
City:
Cleveland
Zip:
44195
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Study Coordinator
Facility:
Name:
Penn State Hershey Medical Center
Address:
City:
Hershey
Zip:
17033
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Study Coordinator
Facility:
Name:
Children's Hospital of Philadelphia
Address:
City:
Philadelphia
Zip:
19104
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Study Coordinator
Facility:
Name:
Texas Children's Hospital
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Study Coordiantor
Start date:
July 2024
Completion date:
July 2026
Lead sponsor:
Agency:
Palvella Therapeutics, Inc.
Agency class:
Industry
Source:
Palvella Therapeutics, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06239480
