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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06239480
Other study ID # PALV-09
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date July 2024
Est. completion date January 2026

Study information

Verified date May 2024
Source Palvella Therapeutics, Inc.
Contact Kathy Goin
Phone 484-612-2335
Email kathy.goin@palvellatx.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main purpose of this study is to assess the change in clinician global impression after 24 weeks of treatment with QTORIN 3.9% Rapamycin Anhydrous Gel compared to placebo in approximately 50 participants with microcystic lymphatic malformations.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date January 2026
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 6 Years and older
Eligibility Key Inclusion Criteria: - Participant must be at least 6 years of age at time of consent - 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
QTORIN 3.9% Rapamycin Anhydrous Gel
QTORIN 3.9% Rapamycin Anhydrous Gel Topical
Placebo
Placebo Topical Gel

Locations

Country Name City State
United States University of North Carolina Chapel Hill North Carolina
United States Cincinnati Children's Hospital Cincinnati Ohio
United States Cleveland Clinic Cleveland Ohio
United States Penn State Hershey Medical Center Hershey Pennsylvania
United States Texas Children's Hospital Houston Texas
United States University of Iowa Iowa City Iowa
United States Minnesota Clinical Study Center New Brighton Minnesota
United States Vascular Birthmark Institute New York New York
United States Stanford University Palo Alto California
United States Children's Hospital of Philadelphia Philadelphia Pennsylvania
United States Mayo Clinic Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Palvella Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinician Global Impression of Change (CGI-C) Comparison from End of Treatment at Week 24 to Baseline
Secondary Change in the Clinician Microcystic LM Multicomponent Severity Scale Change from End of Treatment at Week 24 to Baseline
Secondary Overall patient global impression of change (PGI-C) End of Treatment at Week 24
Secondary Change in overall clinician global impression of change of severity (CGI-S) Change from end of treatment at Week 24 to Baseline
Secondary Change in overall patient global impression of severity (PGI-S) Change from end of treatment at Week 24 to Baseline
Secondary Incidence and severity of adverse events From start of treatment to end of treatment at Week 24
See also
  Status Clinical Trial Phase
Recruiting NCT05050149 - Study Evaluating the Safety and Efficacy of PTX-022 (QTORIN Sirolimus) in the Treatment of Microcystic Lymphatic Malformations Phase 2
Active, not recruiting NCT00975819 - Safety and Efficacy Study of Sirolimus in Complicated Vascular Anomalies Phase 2
Recruiting NCT06160739 - Role of Sirolimus in Treatment of Microcystic , Mixed Lymphatic and Vascular Malformations