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NCT Number: NCT06239480

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Microcystic Lymphatic Malformation Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hemic and Lymphatic Diseases Lymphangioma Lymphatic Abnormalities Lymphatic Diseases Neoplasm, Lymphatic Tissue Neoplasms Neoplasms by Histologic Type Vascular Malformations

Age range

3 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Children's Hospital of Orange County, Irvine, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

QTORIN 3.9% rapamycin anhydrous gel

Drug

QTORIN 3.9% Rapamycin Anhydrous Gel

Primary outcomes

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

    Time frame: At Week 24

    A multi-point scale with higher values indicating improvement.

Secondary outcomes

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

    Time frame: At Week 24

    A multi-point scale with lower values indicating improvement.

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

    Time frame: Change from Baseline to Week 24

    A multi-point scale with lower values indicating improvement.

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

    Time frame: Change from Baseline to Week 24

    A multi-point scale with lower values indicating improvement.

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

    Time frame: Change from Baseline to Week 24

    A multi-point scale with lower values indicating improvement.

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

    Time frame: Change from Baseline to Week 24

    A multi-point scale with lower values indicating improvement.

  6. Incidence and severity of adverse events

    Time frame: From Baseline to Week 24

Sponsors and collaborators

Lead sponsor

Palvella Therapeutics, Inc.

Industry

Collaborators

  • FDA Office of Orphan Products Development

Registry information

Official study 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

Acronym: SELVA

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 2, 2024
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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