Study Details
Testing Sirolimus Topical Gel for People with Cutaneous Venous Malformations
(IRB#: IRB_00188103)
Cutaneous Venous Malformations (cVM) are soft, blue, or purple bumps on the skin caused by malformed veins. Sirolimus topical gel is approved by the United States Food and Drug Administration (FDA) to treat other disorders but is a study drug to test for the potential treatment for people with cVM. The study wants to see if the drug will help people with this condition and is safe. People in the study will complete surveys and use Sirolimus topical get on their skin to treat the condition. Being in the study requires attending about 7 study visits. Of these, 6 will be in person visits at the study clinic lasting 1 to 3 hours each. At least one study visit will be on the phone or video call and last 30 to 60 minutes. Medical tests will be done throughout 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 Cutaneous Venous Malformations, visible on the skin, and venous malformation
- Treatment area on the skin must be a specific size area
- Childbearing age must use specific birth control
- Able to attend in person visits at the study clinic
Exclusion Criteria
- Participation in a previous study testing the drug PTX-022
- Active ulcer in the treatment area
- Diagnosed with PIK3CA-related overgrowth spectrum (PROS)
- Any other condition or situation that impacts the ability for full participation
- Pregnant, breastfeeding, or planning to become pregnant
Will I be paid for my time?
Yes
IRB#: IRB_00188103
PI: Amy Theos
Department: DERMATOLOGY
Approval Date: 2025-03-19 06:00:00
Specialties: Dermatology
I am Interested