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).
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.
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:
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:
The purpose of these remote visits is to help us monitor your progress and gather information without requiring travel to the study site.
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.
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.
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.