Dermatomyositis
Conditions
Interventions
Delgocitinib ointment application
Sponsors
Watanabe Tomoya
Yamaguchi Yukie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Men and women 18 years of age or older at the time of enrollment (2) Patients diagnosed with dermatomyositis (3) Patients with stable interstitial pneumonia or myositis after systemic therapy with oral steroids or immunosuppressive drugs (4) Patients with residual skin rash after systemic therapy with oral steroids or immunosuppressive agents, patients with flare-ups of skin rash after tapering off of oral steroids or immunosuppressive agents, or patients with skin rash alone without myositis or interstitial pneumonia and not eligible for systemic therapy (5) Patients in (4) who have a skin rash refractory to treatment despite standard therapy*. (6) Patients who are able to walk independently and answer questionnaires (7) Patients who give written consent to participate in this study.
Exclusion criteria
Exclusion criteria: (1) Patients with a history of hypersensitivity to delgocitinib (2) Women who are pregnant, lactating, may be pregnant, or wish to become pregnant during the treatment period (3) Patients with severe skin infections (4) Patients with dermatomyositis who have anti-ARS antibody (5) Patients who are judged by doctor to be inappropriate as subjects
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement rate of skin rash after 8 weeks of topical application | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and side effects during the period of topical application. Physician's skin activity assessment VAS and patient's skin activity assessment VAS at 8 weeks after the start of topical application. | — |
Contacts
Public ContactTomoya Watanabe
Yokohama city university hospital
Outcome results
None listed