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Clinical efficacy and safety evaluation of iguratimod for the treatment of oral lichen planus

Clinical efficacy and safety evaluation of iguratimod for the treatment of oral lichen planus

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400079799
Enrollment
Unknown
Registered
2024-01-12
Start date
2024-02-01
Completion date
Unknown
Last updated
2024-01-14

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

Conditions

oral lichen planus

Interventions

Sponsors

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

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. 75 years = Age= 18 years, and sign the informed consent form ; 2. Patients who meet the erosive OLP criteria: (OLP confirmed according to medical history, clinical manifestations and pathological examination, REU=4.5 and U=1) and cannot tolerate or refuse to use hormones; 3. Consent to the use of effective contraceptive methods during the trial; 4. The general condition can tolerate the treatment plan formulated.

Exclusion criteria

Exclusion criteria: 1. Individuals with other confirmed oral mucosal diseases; 2. Oral lichen planus is classified as asymptomatic reticulate type, or oral lichen planus with severe abnormal hyperplasia or cancer; 3. Patients with abnormal liver and kidney function : active liver disease or abnormal liver function, ALT, AST, TBIL is more than 1.5 times the upper limit of normal value, renal function damage, serum creatinine = 133mmol / L ( 1.5mg / dL ); 4. Subjects with white blood cells < 3.0 × 10^9 / L, or clear anemia ( hemoglobin < 80g / L ) or combined with hemolytic anemia, or platelet < 80 × 10^9 / L, or other blood system diseases ; 5. Pregnant or lactating women 6. Serious, uncontrolled systemic diseases, such as blood system diseases, ventricular dysfunction with or without a history of congestive heart failure, or any accompanying conditions, researchers believe that affect the treatment and outcome evaluation, or can not ensure the completion of this study ; 7. The estimated survival time was < 3 months. 8. During the 12 months prior to Visit 1, there was alcoholism, drug dependence, and any investigator 's judgment that the subject could not complete the entire study or that there was a clear risk for the subject to participate in the study; 9. Allergic to iguratimod; 10. There are a variety of other situations where researchers believe that they can not join the clinical trials

Design outcomes

Primary

MeasureTime frame
REU score;

Secondary

MeasureTime frame
REU score;effective index;VAS (visual analogue scale) score;

Countries

China

Contacts

Public ContactShen Xuemin

Department of Oral Medicine, Shanghai Ninth People’s Hospital, Shanghai Jiao Tong University School of Medicine

kiyoshen@163.com+86 158 2133 3957

Outcome results

None listed

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