SELVA: A Phase 3 Study Evaluating 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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06239480

Acronym

SELVA

Enrollment

Registered

2024-02-02

Start date

2024-07-31

Completion date

2026-07-01

Last updated

2026-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Brief 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.

Interventions

DRUGQTORIN 3.9% Rapamycin Anhydrous Gel

QTORIN 3.9% Rapamycin Anhydrous Gel

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

3 Years to No maximum

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame	Description
Overall microcystic lymphatic malformations Investigator Global Assessment (mLM-IGA)	At Week 24	A multi-point scale with higher values indicating improvement.

Secondary

Measure	Time frame	Description
Change in the blinded clinician microcystic lymphatic malformations Multicomponent Severity Scale (mLM-MCSS)	At Week 24	A multi-point scale with lower values indicating improvement.
Change in the live clinician microcystic lymphatic malformations Multicomponent Severity Scale (mLM-MCSS)	Change from Baseline to Week 24	A multi-point scale with lower values indicating improvement.
Overall patient global impression of change (PGI-C)	Change from Baseline to Week 24	A multi-point scale with lower values indicating improvement.
Change in Overall Clinician Global Impression of Severity (CGI-S)	Change from Baseline to Week 24	A multi-point scale with lower values indicating improvement.
Change in Overall Patient Global Impression of Severity (PGI-S)	Change from Baseline to Week 24	A multi-point scale with lower values indicating improvement.
Incidence and severity of adverse events	From Baseline to Week 24	—

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORJoyce Teng

Stanford University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026