A Phase 2, Baseline-Controlled Study Evaluating the Safety and Efficacy of PTX-022 (Sirolimus) Topical Gel 3.9% in the Treatment of Cutaneous Venous Malformations
TOIVA
1 other identifier
interventional
15
1 country
10
Brief Summary
A Phase 2, Baseline-Controlled Study Evaluating the Safety and Efficacy of PTX022 (sirolimus) Topical Gel 3.9% in the Treatment of Cutaneous Venous Malformations
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Dec 2024
Shorter than P25 for phase_2
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 17, 2024
CompletedFirst Posted
Study publicly available on registry
October 22, 2024
CompletedStudy Start
First participant enrolled
December 20, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 21, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2026
CompletedMarch 27, 2026
March 1, 2026
11 months
October 17, 2024
March 26, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of Treatment-Emergent Adverse Events
Week 12
Secondary Outcomes (2)
Change in Investigator Global Assessment (cVM-IGA) From Baseline to Week 12
Change from baseline to Week 12
Overall Patient Global Impression of Change (PGI-C) From Baseline to Week 12
Change from baseline to Week 12
Study Arms (1)
Single-arm, open-label
EXPERIMENTALInterventions
Eligibility Criteria
You may not qualify if:
- The participant's treatment area is mainly in any wet mucosa or within the orbital rim. For clarification, no part of the venous malformation should be evaluated or treated if it in mucosa. External genital presentation is permitted.
- The participant has a known pervasive extension of the lesion into mucosa, bone or tissue (as determined by diagnostic or the investigator) that would impair the ability of the investigator to evaluate the cutaneous components of the lesion.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Children's Hospital of Orange County
Irvine, California, 92612, United States
Stanford University
Palo Alto, California, 94305, United States
Colorado Children's Hospital
Aurora, Colorado, 80045, United States
Johns Hopkins
Baltimore, Maryland, 21287, United States
Minnesota Clinical Study Center
New Brighton, Minnesota, 55112, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
University of North Carolina
Chapel Hill, North Carolina, 27516, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
University of Utah Health
Salt Lake City, Utah, 84113, United States
Related Links
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2024
First Posted
October 22, 2024
Study Start
December 20, 2024
Primary Completion
November 21, 2025
Study Completion
March 1, 2026
Last Updated
March 27, 2026
Record last verified: 2026-03