Genital Lichen Sclerosus
Conditions
Interventions
Intervention group:Tofacitinib
Control group:Fluticasone Propionate Cream
Sponsors
Shandong Provincial Hospital for Skin Diseases & Shandong Provincial Institute of Dermatology and Venerology, Shandong First Medical University & Shandong Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years with histopathologically confirmed diagnosis; 2. Diagnosis of genital lichen sclerosus (GLS) confirmed by two physicians; 3. Inadequate response to previous treatment with topical corticosteroids; 4. Patients voluntarily consent to the off-label use of tofacitinib and sign the treatment informed consent form.
Exclusion criteria
Exclusion criteria: 1. Exclusion of other diseases, etc. 2. Individuals with severe, uncontrolled local or systemic acute or chronic infections within the past 3 months (including systemic infections or severe skin infections requiring parenteral treatment); 3. Patients with a history of allergy to tofacitinib; 4. Individuals who have received immunosuppressive or immunomodulatory drugs (including methotrexate, cyclosporine, azathioprine, prednisone, thalidomide, and apremilast) or other investigational agents, biologics, or immunosuppressants within the past month; 5. Patients with a history of deep vein thrombosis and/or those at high risk of deep vein thrombosis who are not receiving anticoagulant therapy; 6. Patients with lymphocyte count <0.5×10^9/L, neutrophil count <1×10^9/L, hemoglobin level <9 g/dL, or moderate to severe hepatic or renal impairment; 7. Patients with active hepatitis or tuberculosis; 8. Patients with cancer (or a history of multiple cancers); 9. Pregnant or breastfeeding women, or patients planning pregnancy; 10. Patients receiving other immunosuppressive therapies, such as transplant recipients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Investigator’s Global Assessment, IGA; | — |
Secondary
| Measure | Time frame |
|---|---|
| Dermatology Life Quality Index (DLQI);Itch Numerical Rating Scale (NRS); | — |
Countries
China
Contacts
Public ContactHongqing Tian
Shandong Provincial Hospital for Skin Diseases & Shandong Provincial Institute of Dermatology and Venerology, Shandong First Medical University & Shandong Academy of Medical Sciences
Outcome results
None listed