ClinicalTrials.gov record NCT06857240
Topical Ruxolitinib Cream for Refractory Cutaneous Dermatomyositis
Topical Ruxolitinib Cream for Refractory Cutaneous Dermatomyositis
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Phase 2 study testing topical ruxolitinib 1.5% cream in adults with dermatomyositis who have persistent skin symptoms despite prior treatments. All participants receive the cream and researchers measure skin disease activity over weeks, with the main outcome at 8 weeks. The study assesses safety and effects on skin disease activity.
What it is studying. Whether topical ruxolitinib 1.5% cream affects the activity of refractory cutaneous dermatomyositis, measured mainly by change in the Cutaneous Dermatomyositis Activity and Severity Index (CDASI) at 8 weeks (and again at 12 weeks).
What the researchers hope to learn. To assess the safety and effects of topical ruxolitinib 1.5% cream on cutaneous dermatomyositis activity. To measure change in CDASI activity score at 8 weeks (primary) and at 12 weeks (secondary).
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Drug
- Ruxolitinib Topical Cream
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- Patients 18 years and older with refractory cutaneous symptoms related to either classic dermatomyositis (CD), juvenile dermatomyositis (JD), or amyopathic dermatomyositis (AD). Diagnosis will be based on either Bohan and Peter criteria (CD and JD) or Sontheimer's criteria (AD) (19-22).
- Patients must have had a skin biopsy with histologic features consistent with dermatomyositis and current cutaneous manifestations consistent with dermatomyositis.
- Patients will be considered to have refractory disease if cutaneous manifestations exist despite treatment with systemic corticosteroids and at least one steroid-sparing systemic treatment commonly found to be useful in patients with dermatomyositis. These may include azathioprine, cyclosporine, mycophenolate mofetil, IVIG, methotrexate, hydroxychloroquine, cyclophosphamide, chlorambucil, sirolimus, tacrolimus, and rituximab.
- Patients must have sufficiently active cutaneous involvement of dermatomyositis (BSA>1% to <20%, CDASI activity score > 6, and Physician Global Assessment (PGA) activity score >2).
- Patients must have tried and failed at least one commonly prescribed topical medication in the past, with the last application of a topical medication to active skin lesions occurring greater than 2 weeks prior to enrollment.
- o Commonly prescribed topical medications for dermatomyositis include corticosteroids or calcineurin inhibitors (tacrolimus or pimecrolimus).
- Patients must have been on a stable systemic medication regimen for at least 2 months (60 days) and must agree to keep the regimen stable throughout the study period. As patients with dermatomyositis are commonly treated with combination regimens that include both topical and systemic immunosuppressive medications, any added risk of adverse effects related to ruxolitinib 1.5% cream is considered negligible.
- Patients must be agreeable to use appropriate contraceptive measures while enrolled in the study.
- Women of childbearing potential must be willing to practice abstinence or use either an oral contraceptive medication or IUD if sexually active.
- Women of childbearing potential must be willing to have monthly urine pregnancy tests while enrolled in the study
- Men of childbearing potential must be willing to practice abstinence or use condoms if sexually active.
Exclusion criteria
- Patients with dermatomyositis who have minimal-to-no active cutaneous disease (mild involvement with < 1% total body surface area involved and/or CDASI activity score of < 6).
- Patients who have > 20% total BSA involvement of cutaneous dermatomyositis.
- Patients who have used a common prescription topical medication within the previous 2 weeks.
- Patients whose cutaneous findings are not consistent with dermatomyositis and/or have previous biopsy results suggestive of an alternative diagnosis
- Patients not on stable systemic medication regimens for at least 2 months and/or who will not agree to keep the regimen stable throughout the study period.
- Patients who have previously taken a systemic Janus kinase inhibitor but had a poor response, patients who are currently taking systemic Janus kinase inhibitors, or patients who have used a topical Janus kinase inhibitor for their dermatomyositis or any other condition and had poor responses.
- Patients with inflammatory myositis other than dermatomyositis, such as polymyositis or inclusion body myositis.
- Patients with clear features of an overlap autoimmune myositis or with an inflammatory myositis not consistent with dermatomyositis, such as polymyositis or inclusion body myositis.
- Patients with an active malignancy other than non-melanoma skin cancer, or with malignancy-associated dermatomyositis.
- Patients younger than 18 years old
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Detailed description from the registry
Dermatomyositis (DM) is an immune-mediated disease that most commonly affects the skin and the muscles. Cutaneous involvement of DM can lead to ulceration with secondary infection, in addition to permanent skin damage in the form of atrophy, scarring, calcinosis, decreased range of motion or lipoatrophy. Furthermore, persistent cutaneous DM is associated with adverse psychological effects and physical symptoms such as pain, burning, and pruritus. The combination of these contribute to a significant negative impact on DM patients' quality of life. Thus, effective treatment of cutaneous DM represents an important therapeutic goal. Cutaneous DM symptoms and inflammation are often refractory to currently available topical medications . Additionally, continued topical corticosteroid use is associated with well-known adverse effects, including potential worsening of DM-related skin atrophy and adrenal insufficiency. Recently, topical ruxolitinib has been developed and studied in several dermatologic conditions. In phase 2 and 3 trials in atopic dermatitis, topical ruxolitinib 1.5% cream resulted in significant efficacy in terms of improving both disease activity and itching, without significant side effects. The investigators propose to study use of topical ruxolitinib 1.5% cream as an adjunct for treatment of refractory cutaneous DM lesions in patients who have previously failed other topical medication options.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants will apply topical ruxolitinib 1.5% cream to affected skin as directed and attend study visits for skin assessments, including measurement of disease activity at about 8 weeks and again at about 12 weeks. Safety monitoring and skin exams will be performed during study visits. Women of childbearing potential must agree to contraception or abstinence and to monthly urine pregnancy tests while enrolled; men of childbearing potential must agree to condom use or abstinence. Participants must keep their systemic medication regimen stable and must not have used a qualifying topical medication on active lesions within 2 weeks before starting.
How the study is structured. Phase 2, single-group, open-label interventional trial: every enrolled adult receives topical ruxolitinib 1.5% cream. Skin disease activity and safety are measured before and after treatment, with primary outcome assessed at 8 weeks and a secondary assessment at 12 weeks.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on dermatomyositis
This trial is also listed on this site under polymyositis.
Important dates
- Study start
- Jun 1, 2025
- Primary completion
- December 2026 (estimated)
- Study completion
- December 2027 (estimated)
- Target enrollment
- 15 participants (estimated)
- Last updated on registry
- Oct 8, 2025
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- The Cleveland Clinic
- Principal investigator
- Anthony Fernandez, MD, PhD, Director of Medical Dermatology; W.D. Steck Chair of Clinical Dermatology
The Cleveland Clinic
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Anthony Fernandez, MD 📞 216 445-8776 ✉ dermatologyresearch@ccf.org
- Rothy Rim 📞 2164447277 ✉ dermatologyresearch@ccf.org
Participating sites (1)
- Cleveland ClinicRecruiting
Cleveland, Ohio, 44195 · United States
- Anthony Fernandez, MD
Terms used on this page · explanations by MedicalUpdates.ai
- refractory
- A condition that has not responded to a treatment. 'Relapsed' means it responded and then came back; 'refractory' means it did not respond in the first place.
- biopsy
- Removal of a small piece of tissue so it can be examined under a microscope. 'Biopsy-proven' or 'histologically confirmed' means the diagnosis was confirmed by examining tissue under a microscope.
- corticosteroids
- Steroid medicines, such as prednisone, that reduce inflammation. Studies often require a stable dose at entry or measure whether the study treatment allows the dose to be reduced.
- hydroxychloroquine
- A medicine used for some autoimmune conditions. It appears in eligibility criteria when a study requires or excludes its use.
- enrollment
- The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
- immunosuppressive
- A medicine that reduces the activity of the immune system. Studies of autoimmune conditions often require a stable dose, a prior failure, or a washout of such medicines.
- Women of childbearing potential
- Studies often ask participants who could become pregnant, or could father a child, to use contraception during the study and for a period afterwards, because the effect of the treatment on a pregnancy is unknown.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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