Actively Recruiting
Topical Ruxolitinib Cream for Refractory Cutaneous Dermatomyositis
Led by The Cleveland Clinic · Updated on 2025-10-08
15
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will assess the safety and efficacy of topical ruxolitinib for treating the refractory cutaneous manifestations in patients with dermatomyositis. The investigators' hypothesis is that topical ruxolitinib will be both safe and effective for such patients.
CONDITIONS
Official Title
Topical Ruxolitinib Cream for Refractory Cutaneous Dermatomyositis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years and older with refractory cutaneous symptoms related to classic dermatomyositis, juvenile dermatomyositis, or amyopathic dermatomyositis
- Diagnosis based on Bohan and Peter criteria (CD and JD) or Sontheimer's criteria (AD)
- Skin biopsy confirming dermatomyositis with current skin symptoms consistent with dermatomyositis
- Refractory disease defined by persistent skin symptoms despite systemic corticosteroids and at least one other steroid-sparing systemic treatment
- Active skin involvement with body surface area >1% to <20%, CDASI activity score >6, and Physician Global Assessment score >2
- Prior failure of at least one commonly prescribed topical medication, with last use over 2 weeks before enrollment
- Stable systemic medication regimen for at least 60 days and agreement to keep it stable during the study
- Agreement to use contraceptive measures during the study, including monthly pregnancy tests for women of childbearing potential
- Women of childbearing potential willing to practice abstinence or use oral contraceptives or IUD if sexually active
- Men of childbearing potential willing to practice abstinence or use condoms if sexually active
You will not qualify if you...
- Minimal or no active cutaneous dermatomyositis (body surface area <1% or CDASI activity score <6)
- Extensive skin involvement with >20% body surface area
- Use of prescription topical medication within 2 weeks prior to enrollment
- Skin findings inconsistent with dermatomyositis or biopsy suggesting another diagnosis
- Unstable systemic medication regimen or unwillingness to keep regimen stable
- Prior poor response to systemic Janus kinase inhibitors, current use of systemic Janus kinase inhibitors, or poor response to topical Janus kinase inhibitors
- Inflammatory myositis other than dermatomyositis such as polymyositis or inclusion body myositis
- Overlap autoimmune myositis or inflammatory myositis not consistent with dermatomyositis
- Active cancer other than non-melanoma skin cancer or malignancy-associated dermatomyositis
- Age younger than 18 years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
A
Anthony Fernandez, MD
CONTACT
R
Rothy Rim
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here