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mTOR Inhibitor

Rapamycin Gel for Microcystic Lymphatic Malformations (SELVA Trial)

Phase 3
Recruiting
Led By Joyce Teng
Research Sponsored by Palvella Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant must be at least 6 years of age at time of consent
Participant must have a clinically confirmed superficial/cutaneous microcystic lymphatic malformation
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 24
Awards & highlights

Summary

This trial aims to see if using QTORIN 3.9% Rapamycin Anhydrous Gel for 24 weeks can improve the clinician's overall impression in 50 people with

Who is the study for?
This trial is for individuals over the age of 6 with a confirmed diagnosis of superficial or cutaneous microcystic lymphatic malformation. It's not suitable for those with vascular malformations that could affect evaluation, severe systemic symptoms from complicated vascular anomalies, treatment areas within wet mucosa or the orbital rim, or if pregnant.
What is being tested?
The study aims to compare the effectiveness of QTORIN 3.9% Rapamycin Anhydrous Gel versus a placebo in treating microcystic lymphatic malformations. Participants will be randomly assigned to receive either the gel or placebo and monitored over 24 weeks.
What are the potential side effects?
While specific side effects are not listed here, rapamycin can generally cause skin irritation at the application site, increased risk of infections due to its immune-suppressing properties, and possible impact on wound healing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am at least 6 years old.
Select...
I have a confirmed superficial skin lymphatic issue.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My vascular malformations do not affect the assessment of my lymphatic malformation.
Select...
I have severe symptoms from vascular anomalies needing treatment.
Select...
My treatment area is mainly in wet mucosa or near the eye socket.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall microcystic lymphatic malformations Investigator Global Assessment (mLM-IGA)
Secondary outcome measures
Change in Overall Clinician Global Impression of Severity (CGI-S)
Change in Overall Patient Global Impression of Severity (PGI-S)
Change in the blinded clinician microcystic lymphatic malformations Multicomponent Severity Scale (mLM-MCSS)
+2 more

Side effects data

From 2020 Phase 2 & 3 trial • 852 Patients • NCT01120028
49%
Infections and infestations
20%
Surgical and medical procedures
17%
Immune system disorders
14%
Gastrointestinal disorders
12%
Investigations
10%
Metabolism and nutrition disorders
9%
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
7%
Injury, poisoning and procedural complications
5%
Cardiac disorders
4%
Respiratory, thoracic and mediastinal disorders
4%
Renal and urinary disorders
4%
Nervous system disorders
3%
General disorders and administration site conditions
2%
Blood and lymphatic system disorders
2%
Musculoskeletal and connective tissue disorders
2%
Vascular disorders
2%
Hepatobiliary disorders
1%
Eye disorders
1%
Skin and subcutaneous tissue disorders
100%
80%
60%
40%
20%
0%
Study treatment Arm
Period 2: Sirolimus
Period 1: Alemtuzumab/Tacrolimus
Period 1: Basiliximab/Tacrolimus
Period 2: Tacrolimus

Trial Design

1Treatment groups
Experimental Treatment
Group I: ActiveExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Palvella Therapeutics, Inc.Lead Sponsor
6 Previous Clinical Trials
326 Total Patients Enrolled
1 Trials studying Microcystic Lymphatic Malformation
12 Patients Enrolled for Microcystic Lymphatic Malformation
Joyce TengPrincipal InvestigatorStanford University
1 Previous Clinical Trials
22 Total Patients Enrolled
~27 spots leftby Jan 2026
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