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Active, not recruitingNCT06239480SELVAUpdated Mar 27, 2026

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

A Phase 3 interventional study of QTORIN 3.9% Rapamycin Anhydrous Gel in Microcystic Lymphatic Malformation, sponsored by Palvella Therapeutics, Inc.. Active, not recruiting at 15 sites in United States. Open to participants aged 3 Years and older. Per ClinicalTrials.gov, last updated 2026-03-27.

Sponsored by Palvella Therapeutics, Inc. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
51
Allocation
Not applicable
Ages
3 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Microcystic Lymphatic Malformation

Keywords

  • Lymphangioma circumscriptum
  • Lymphatic malformation
  • Vascular malformation
  • Topical
  • Sirolimus
  • Rapamycin
  • Congenital malformation
  • Non-infective disorder of lymphatic vessels and lymph nodes
03

In context

Lymphangioma

13 studies on the registry are indexed under Lymphangioma; 5 are open to participants now.

Browse Lymphangioma studies →

Lead sponsor

Palvella Therapeutics, Inc. is the lead sponsor of 9 studies on the registry; 2 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

  • 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:

  • 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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
51 participants (actual)

Study arms

  • Experimental
    Active

    Drug: QTORIN 3.9% Rapamycin Anhydrous Gel

Interventions

  • DrugQTORIN 3.9% Rapamycin Anhydrous Gel

    QTORIN 3.9% Rapamycin Anhydrous Gel

06

What researchers measure

Primary outcomes

  1. Overall microcystic lymphatic malformations Investigator Global Assessment (mLM-IGA)

    A multi-point scale with higher values indicating improvement.

    Time frame: At Week 24

Secondary outcomes

  1. Change in the blinded clinician microcystic lymphatic malformations Multicomponent Severity Scale (mLM-MCSS)

    A multi-point scale with lower values indicating improvement.

    Time frame: At Week 24

  2. Change in the live clinician microcystic lymphatic malformations Multicomponent Severity Scale (mLM-MCSS)

    A multi-point scale with lower values indicating improvement.

    Time frame: Change from Baseline to Week 24

  3. Overall patient global impression of change (PGI-C)

    A multi-point scale with lower values indicating improvement.

    Time frame: Change from Baseline to Week 24

  4. Change in Overall Clinician Global Impression of Severity (CGI-S)

    A multi-point scale with lower values indicating improvement.

    Time frame: Change from Baseline to Week 24

  5. Change in Overall Patient Global Impression of Severity (PGI-S)

    A multi-point scale with lower values indicating improvement.

    Time frame: Change from Baseline to Week 24

  6. Incidence and severity of adverse events

    Time frame: From Baseline to Week 24

07

Study locations

15 sites
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2024 to primary completion in Jan 2026, 17 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 16, 2024
First posted
Feb 2, 2024
StartActual
Jul 31, 2024
Primary completionActual
Jan 14, 2026
CompletionEst.
Jul 2026
Last update
Mar 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06239480
Lead sponsor
Palvella Therapeutics, Inc.
Collaborators
FDA Office of Orphan Products Development
Responsible party
Sponsor
First posted
Feb 2, 2024
Start date
Jul 31, 2024
Primary completion
Jan 14, 2026
Completion
Jul 2026 (estimated)
Last update
Mar 27, 2026

Study contacts

Joyce Teng
principal investigator · Stanford University

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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