Study Details
Testing the Drug PTX-022 for People with Microcystic Lymphatic Malformations
(IRB#: IRB_00188357)
Microcystic Lymphatic Malformations (mLM) is a rare disease of the lymphatic system characterized by abnormal vessels, outpouchings, or cysts filled with lymphatic fluid under the skin. The disease is usually present at birth and worsens overtime. This study will test a drug called PTX-022 to treat people with this disease. The study wants to see if the drug will help people with the disease and is safe. Participants will apply the study drug as a topical ointment on the area affected by mLM. Participants will share medical history, have a medical exam, complete interviews, have pictures taken of the area where the study drug was applied. Being in the study requires attending both in person visits at the study clinic and remote visits over about 168 days. Medical tests will be done during the study to track the health of participants.
- All genders
- All Ages
- Volunteers with special conditions
- In Person
- Paid
Who can participate?
Gender: All genders
Age: All Ages
Volunteers: Volunteers with special conditions
Location: In Person
Inclusion Criteria
- Ages 6 years and older
- Diagnosed with Microcystic Lymphatic Malformations visible on the skin
- Microcystic Lymphatic Malformations with specific criteria
- At least 4 weeks since having any major surgery and at least 12 weeks since surgery on the Microcystic Lymphatic Malformations area
- At least 5 months since receiving any field radiation to the Microcystic Lymphatic Malformations area
Exclusion Criteria
- Participation in another PTX-022 drug study
- Pregnant or breastfeeding
- Childbearing ages unwilling to use specific birth control during study participation including the follow up period
- Injury to the treatment area that impacts full participation
- Cancer within the past 5 years unless otherwise determined safe by the study
Will I be paid for my time?
Yes
IRB#: IRB_00188357
PI: Amy Theos
Department: DERMATOLOGY
Approval Date: 2025-03-19 06:00:00
Specialties: Dermatology
I am Interested