erosive oral lichen planus
Conditions
Interventions
Treatment group:Tretinoin tablets + hydroxychloroquine sulfate tablets + methylprednisolone tablets
Control group:Hydroxychloroquine sulfate tablets + methylprednisolone tablets
Sponsors
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years old (including cut-off values at both ends); 2. In addition to the white lesion, the patient's lesion site is hyperemia, erosion, and ulceration between the lines and the mucosa around the lesion, and is confirmed as erosive oral lichen planus within 6 months by clinical diagnosis and histopathology. 3. Clinical severity score ODSS score >=10 points (activity score of at least one site >=3 points); 4. Able and willing to sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; 2. Those who are allergic to the ingredients or excipients in the study drug; 3. Those who have contraindications to the use of experimental drugs, including but not limited to the contraindications listed in the drug instructions; 4. After treatment, glycated hemoglobin = 1.5 times the upper limit of normal value in diabetic patients; 5. Patients with severe liver and kidney function abnormalities (ALT> 2 times the upper limit of normal value, AST> 2 times the upper limit of normal value, total bilirubin > 2 times the upper limit of normal value, creatinine > 2 times the upper limit of normal value, BUN> upper limit of normal value 2 times); 6. Contact lichenoid reactions caused by silver amalgam fillings or other oral prosthetic materials or irritants; 7. Patients with clear drug-induced lichenoid reactions; 8. Patients with pre-existing fundus macular or other fundus diseases; 9. Patients with a definite diagnosis of systemic autoimmune disease; 10. Patients with tuberculosis and hematological tumors in the past; 11. Patients who have received systemic immunotherapy within 3 months, local therapy within 1 week prior to study treatment, or systemic treatment for OLP within 1 month; 12. Fungal and bacterial infectious diseases of the oral cavity and pharynx that cannot be controlled after treatment; 13. All laboratory or clinical HIV infection, syphilis infection, active hepatitis C, uncontrolled active hepatitis B; 14. Patients with other concomitant diseases that seriously endanger the safety of the patient or affect the completion of the study according to the judgment of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Week 12 Response Rate (CR + VGPR Rate); | — |
Secondary
| Measure | Time frame |
|---|---|
| OHIP-14 score-related parameters;Recurrence rate after treatment;Week 4 Response Rate;Distribution of Response Rates;Laboratory Safety Parameters;Vital Signs;12-Lead Electrocardiogram (ECG);Adverse Events (AE);Time to Complete Remission;Week 8 Response Rate; | — |
Countries
China
Contacts
Public ContactXuemin Shen
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Outcome results
None listed