Oral lichen planus
Conditions
Interventions
Ivarmacitinib treatment group:1. Weeks 0-8 after enrollment: Ivarmacitinib Sulfate Tablets, 4 mg/day orally + Triamcinolone Acetonide Oral Ointment, applied topically to lesions twice daily
2. Weeks 9-16 after enrollment: Ivarmacitinib Sulfate Tablets, 4 mg/day orally + Triamcinolone Acetonide Oral Ointment, applied topically to lesions twice daily
3. Weeks 17-20 after enrollment: Safety follow-up.
Placebo control group:1. Weeks 0-8 after enrollment: Placebo control, 4 mg/day orally + Triamcinolone Acetonide Oral Ointment, applied topically to lesions twice daily
Sponsors
The First Affiliated Hospital of Air Force Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18–75 years, no gender limitation; 2.Patients with clinically and/or histopathologically confirmed moderate-to-severe oral lichen planus, with an Oral Disease Severity Score (ODSS) =10 points (including at least one lesion site with an activity score =3 points); 3.Patients who have failed at least one conventional systemic therapy [regular treatment with standard doses for at least 4 weeks] or have recurrent disease; 4.Judged by clinicians to be suitable for Ivarmacitinib Sulfate Tablets treatment; 5.Voluntary participation and signed informed consent.
Exclusion criteria
Exclusion criteria: 1.Pregnant or lactating women; subjects with known or suspected poor compliance who cannot complete the study; individuals with alcoholism, drug dependence, or mental illness, as judged by the investigator to be unsuitable for participation. 2.History of long-acting glucocorticoid submucosal injection within 1 month, or oral glucocorticoids, thalidomide, hydroxychloroquine sulfate, or other immunosuppressive drugs within 2 weeks. 3. Clinical history suggesting suspected lichenoid drug eruption or paraneoplastic oral lichen planus. 4. Current participation in any other clinical trial involving investigational drugs or devices. 5. Underlying systemic conditions (including but not limited to metabolic, hematological, renal, hepatic, pulmonary, neurological, endocrine, cardiac, infectious, or gastrointestinal) and/or laboratory abnormalities that, in the investigator’s judgment, significantly impair immune function and/or pose unacceptable risks for immunomodulatory therapy. 6. Severe, progressive, or uncontrolled diseases, including any medical or psychiatric condition that would hinder adherence to the study protocol, as determined by the investigator. 7. Inability to comply with follow-up requirements per the study protocol; 8.subjects with incomplete clinical data.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Oral Disease Severity Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Investigator’s global assessment;Reticulation Hyperemia and Ulceration score;Oral Lichen Planus Symptom Severity Measure;Patient Global Impression of Change;Self-Rating Anxiety Scale;Self-Rating Depression Scale;Pittsburgh sleep quality index;Number of days of triamcinolone acetonide oral paste use in the past week; | — |
Countries
China
Contacts
Public ContactShuai Shao
The First Affiliated Hospital of Air Force Medical University
Outcome results
None listed