New cream could soothe skin in rare autoimmune disease
NCT ID NCT06857240
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a cream containing ruxolitinib on the skin of 15 adults with dermatomyositis whose skin symptoms haven't improved with standard treatments. The cream is applied to affected areas for up to 12 weeks to see if it reduces redness, scaling, and other signs of disease activity. The goal is to find a safer, targeted option for managing skin flares without strong pills or injections.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ruxolitinib topical cream (1.5%)
- What this could lead to
- If it works, this could offer a new topical treatment option for stubborn skin symptoms in dermatomyositis, potentially reducing the need for stronger systemic medications.
- What could go wrong
- This is a very small early-phase trial (15 people) with no placebo group, so results may not be conclusive. The cream may not work for everyone, and side effects are still being studied.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 89 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
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Contact
Email: •••••@•••••
Locations
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Cleveland Clinic
RECRUITINGCleveland, Ohio, 44195, United States
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