Microcystic Lymphatic MalformationPhase 3SELVANCT06239480
SELVA: A Phase 3 Study Evaluating QTORIN 3.9% Rapamycin Anhydrous Gel in the Treatment of Microcystic Lymphatic Malformations
A Phase 3 study testing QTORIN 3.9% Rapamycin Anhydrous Gel in people with Microcystic Lymphatic Malformation, run by Palvella Therapeutics, Inc. at 15 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Microcystic Lymphatic Malformation
- What is being tested?
- QTORIN 3.9% Rapamycin Anhydrous Gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 15 sitesUnited States
- Study dates
- 31 Jul 2024to Jul 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Children's Healthcare of Atlanta
Atlanta, Georgia, 30342
University of Texas, Dell Children's
Austin, Texas, 78723
University of North Carolina
Chapel Hill, North Carolina, 27516
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
Cleveland Clinic
Cleveland, Ohio, 44195
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
Texas Children's Hospital
Houston, Texas, 77030
Children's Hospital of Orange County
Irvine, California, 92612
Vanderbilt Children's Hospital
Nashville, Tennessee, 37232
Minnesota Clinical Study Center
New Brighton, Minnesota, 55112
Vascular Birthmark Institute
New York, New York, 10016
Stanford University
Palo Alto, California, 94305
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Mayo Clinic
Rochester, Minnesota, 55905
University of Utah Health
Salt Lake City, Utah, 84113
About this study
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
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.
- Conditions
- Microcystic Lymphatic Malformation
- Being tested
- QTORIN 3.9% Rapamycin Anhydrous Gel
- Keywords
- Lymphangioma circumscriptum, Lymphatic malformation, Vascular malformation, Topical, Sirolimus, Rapamycin, Congenital malformation, Non-infective disorder of lymphatic vessels and lymph nodes
- Medical subject headings
- Lymphangioma, Lymphatic Abnormalities, Vascular Malformations, Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QTORIN 3.9% Rapamycin Anhydrous GelDrug
QTORIN 3.9% Rapamycin Anhydrous Gel
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Not described Receives: Drug: QTORIN 3.9% Rapamycin Anhydrous Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall microcystic lymphatic malformations Investigator Global Assessment (mLM-IGA)
A multi-point scale with higher values indicating improvement.
Measured: At Week 24
Secondary outcomes (6)
Change in the blinded clinician microcystic lymphatic malformations Multicomponent Severity Scale (mLM-MCSS)
A multi-point scale with lower values indicating improvement.
Measured: At Week 24
Change in the live clinician microcystic lymphatic malformations Multicomponent Severity Scale (mLM-MCSS)
A multi-point scale with lower values indicating improvement.
Measured: Change from Baseline to Week 24
Overall patient global impression of change (PGI-C)
A multi-point scale with lower values indicating improvement.
Measured: Change from Baseline to Week 24
Change in Overall Clinician Global Impression of Severity (CGI-S)
A multi-point scale with lower values indicating improvement.
Measured: Change from Baseline to Week 24
Change in Overall Patient Global Impression of Severity (PGI-S)
A multi-point scale with lower values indicating improvement.
Measured: Change from Baseline to Week 24
Incidence and severity of adverse events
Measured: From Baseline to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start31 Jul 2024
- Primary completion14 Jan 2026
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microcystic Lymphatic MalformationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Palvella Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- FDA Office of Orphan Products Development
- Responsible party
- Sponsor
- Investigators
- Joyce Teng, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06239480
- Sponsor's protocol ID
- PALV-09
- Acronym
- SELVA
- Status last verified
- Mar 2026
- First submitted
- 16 Jan 2024
- Last updated
- 27 Mar 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06239480
- Acronym / sponsor ID
- SELVA / PALV-09
- Conditions
- Microcystic Lymphatic Malformation
- Keywords
- Lymphangioma circumscriptum, Lymphatic malformation, Vascular malformation, Topical, Sirolimus, Rapamycin, Congenital malformation, Non-infective disorder of lymphatic vessels and lymph nodes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Palvella Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- FDA Office of Orphan Products Development
- Study start
- 31 Jul 2024 (actual)
- Primary completion
- 14 Jan 2026 (actual)
- Study completion
- Jul 2026 (estimated)
- First posted
- 2 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: QTORIN 3.9% Rapamycin Anhydrous Gel |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QTORIN 3.9% Rapamycin Anhydrous GelQTORIN 3.9% Rapamycin Anhydrous Gel | Drug | Active |
Primary outcome
Overall microcystic lymphatic malformations Investigator Global Assessment (mLM-IGA)
Time frame: At Week 24
A multi-point scale with higher values indicating improvement.
6 secondary outcomes
Change in the blinded clinician microcystic lymphatic malformations Multicomponent Severity Scale (mLM-MCSS)
Time frame: At Week 24
Change in the live clinician microcystic lymphatic malformations Multicomponent Severity Scale (mLM-MCSS)
Time frame: Change from Baseline to Week 24
Overall patient global impression of change (PGI-C)
Time frame: Change from Baseline to Week 24
Change in Overall Clinician Global Impression of Severity (CGI-S)
Time frame: Change from Baseline to Week 24
Change in Overall Patient Global Impression of Severity (PGI-S)
Time frame: Change from Baseline to Week 24
Incidence and severity of adverse events
Time frame: From Baseline to Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joyce Teng principal investigator
Stanford University
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing QTORIN 3.9% Rapamycin Anhydrous Gel in people with Microcystic Lymphatic Malformation, run by Palvella Therapeutics, Inc. at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall microcystic lymphatic malformations Investigator Global Assessment (mLM-IGA) (time frame: At Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.