Topical Ruxolitinib for Cutaneous Chronic Graft Versus Host Disease (cGVHD)
Status:
Recruiting
Trial end date:
2024-04-01
Target enrollment:
Participant gender:
Summary
Background:
About half the people who have a hematopoietic stem cell transplant using donor cells get
cGVHD. This is chronic graft versus host disease. Immune cells from the donor may see the
body tissues in the person as foreign and attack, causing damage. The skin is the most
commonly affected organ. Most cGVHD therapies have serious side effects. The cream
ruxolitinib inhibits proteins that may play a role in cGVHD.
Objective:
To test the safety and effectiveness of topical ruxolitinib 1.5 percent cream in people with
cGVHD of the skin.
Eligibility:
People ages 12 and older with epidermal skin cGVHD
Design:
Participants will be screened with:
Medical history
Physical exam
Blood and urine tests
Skin sample taken (biopsy) to confirm the diagnosis.
At the baseline visit, participants will have:
Skin disease measured with rulers, photographs, and tracing the outline of skin lesions
To complete questionnaires about their symptoms
Blood and urine tests
Some participants will also have a skin biopsy, or total body photographs while they wear
only underwear.
Participants will get the ruxolitinib cream and a placebo cream to apply to 2 separate areas
of disease. They will do this twice a day for 6 weeks, if they do not have serious side
effects. Neither the study team nor the participant will know which area will get ruxolitinib
cream and the placebo cream.
Participants will write down:
- When they apply the creams
- Any side effects
- Any medications they take
Most participants will have 4 visits during the 6 weeks they use the creams. Some will have 3
visits and a phone call to see how they are doing. All participants will get a call 4-6 weeks
after they stop. Visits include physical exams, blood tests, skin disease measurements,
questionnaires, and photos.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)