SELVA: A Phase 3 Study Evaluating QTORIN 3.9% Rapamycin Anhydrous Gel in the Treatment of Microcystic Lymphatic Malformations
Purpose
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.
Condition
- Microcystic Lymphatic Malformation
Eligibility
- Eligible Ages
- Over 6 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
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 Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Active |
|
Recruiting Locations
Vanderbilt Children's Hospital
Nashville, Tennessee 37232
Nashville, Tennessee 37232
Contact:
Study Coordinator
Study Coordinator
More Details
- Status
- Recruiting
- Sponsor
- Palvella Therapeutics, Inc.