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A multicenter cohort study of the effectiveness of oral prednisone tablets inpatients with oral lichenoid lesions

A multicenter cohort study of the effectiveness of oral prednisone tablets inpatients with oral lichenoid lesions

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400092240
Enrollment
Unknown
Registered
2024-11-12
Start date
2023-04-10
Completion date
Unknown
Last updated
2024-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Lichenoid Lesion

Interventions

Experimental group:Prednisone tablet, 5mg/ tablet, once a day in the morning, 3 tablets each time (for 2 weeks), once a day in the morning in the 3rd week, 2 tablets each time (for 1 week), once a day

Sponsors

Shanghai Ninth People’s Hospital, Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) at least 18 years of age; (2) The patient was diagnosed with oral lichenoid lesions according to medical history, clinical manifestations and pathological examination, and the VAS score was =1; (3) The patient participate in the trial voluntarily, can participate in the trial review on time and can complete the whole trial steps; (4) Patients agree to participate in the trial and voluntarily sign informed consent, and can voluntarily provide personal medical history.

Exclusion criteria

Exclusion criteria: (1) Individuals who are allergic to the drugs used in this study or have an allergic constitution; (2) Patients with other identified oral mucosal diseases, or oral lichenoid lesions classified as asymptomatic leukoplakia, or with severe dysplasia or canceration; (3) Patients with serious systemic diseases or tumors; (4) Participants in other clinical trials within the past 3 months; (5) Individuals with oral lichenoid reactions who exposed to certain drugs or silver amalgam fillings; (6) Pregnant and lactating women and those who intend to become pregnant during the trial (according to the information provided by the subject); (7) Patients who need to take antibiotics, hormones, non-steroidal anti-inflammatory drugs, immunosuppressants, immunoenhancers, cytotoxic drugs, cell cycle drugs or anticoagulant drugs that affect oral mucosa regularly due to other chronic diseases, including after transplantation; (8) Serious alcohol and tobacco addicts (drinking >15 units per week, each unit refers to: 350ml beer or 150ml wine or 50ml spirits; Smoking >25 cigarettes/day); (9) Any mental illness, or any other illness which may result in a legal determination of limited capacity.

Design outcomes

Primary

MeasureTime frame
(reticular, erythema and ulcerative, REU) scores;

Secondary

MeasureTime frame
visual analog scale, VAS;Thongprasom scores;Efficacy indices, El;

Countries

China

Contacts

Public ContactGuoyao Tang

Xinhua Hospital, Shanghai Jiaotong UniversitySchool of Medicine

tanggy@shsmu.edu.cn+86 182 2106 6618

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026