Clinical Trials / Research Studies
SELVA Study: A Multicenter, Phase 3 Baseline-Controlled Study Evaluating the Safety and Effectiveness of PTX-022 in Treating Microcystic Lymphatic Malformations
Why are we doing this research?
The main goal of this study is to evaluate the safety and effectiveness of PTX-022, a new once-daily topical formulation, in helping people with Microcystic Lymphatic Malformations (mLM).
Who can participate?
You may be eligible for this study if you have a clinically confirmed superficial/cutaneous microcystic lymphatic malformation and are at least 6 years old.
Conditions
- Hematology - Hemangioma and Vascular Malformation
What will happen in the study?
The study involves at least 8 visits over a period of 14 months, with both onsite and remote visits.
1. Onsite Visits:
You will have 5 onsite visits at the study site with your study team. These visits will include:
- Detailed assessments
- Questionnaires
- Targeted physical exams
- Photography
- Collection of height, weight, and vital signs
- Blood draws
2. Remote Visits:
There will be at least 2 remote visits during the study, and one follow-up remote visit at the end. These visits can be done by phone or other remote methods, so you won’t need to come to the study site. These remote visits will include:
- Assessments and questionnaires conducted via phone calls or video calls
- Monitoring of your progress and well-being
- Collection of data to track your symptoms and response to treatment
The purpose of these remote visits is to help us monitor your progress and gather information without requiring travel to the study site.
What are the good things that can happen from this research?
While we cannot guarantee any specific benefits, participating in this study may help with the following:
1. Improvement in your mLM symptoms and/or the appearance of your mLM.
2. Helping the study doctor and other researchers learn more about how to treat mLM.
What are the bad things that can happen from this research?
The treatment used in this study may affect different parts of your body, such as the liver, kidneys, heart, and blood, which could cause side effects. We will closely monitor you for any health concerns during the study.
Will you/your child be paid to be in this research study?
Yes, you will be compensated up to $850 with for your time and participation in the study visits. If you need to travel to the study site, you will be reimbursed for all reasonable travel expenses.
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