Atopic dermatitis combined with hyperlipidemia and fatty liver
Conditions
Interventions
UDCA treatment group:Oral UDCA capsules (purchased from hospital pharmacy and provided as free medication), administered according to drug instructions (10mg/kg), twice daily, one capsule (250mg) each
treatment duration of 12 weeks. Background medications remain unchanged, recommended background therapy includes topical medium-potency corticosteroids or topical calcineurin inhibitors combined with
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Age range: 18 to 65 years old; Gender not limited; 2.Patients diagnosed with AD who meet the Yao/Zhang diagnostic criteria and exclude infections, tumors, and other connective tissue diseases; 3.After at least 4 weeks of fixed background treatment (topical medium acting glucocorticoids or topical calcineurin inhibitors combined with moisturizers, oral conventional doses of second-generation antihistamines), AD patients show no significant improvement or acute exacerbation of skin lesions, with SCORAD score >= 25 or EASI score >= 7, and SCORAD or EASI score fluctuation amplitude <= 25% after 4 weeks of background treatment. 4.Combined with abnormal lipid metabolism, meeting at least one objective criterion: fasting triglycerides (TG) 1.7-2.3 mmol/L; Or fasting low-density lipoprotein cholesterol (LDL-C) 3.4-4.1 mmol/L; Or fasting non high density lipoprotein cholesterol (HDL) 4.1-4.9 mmol/L or abdominal ultrasound examination report within 6 months before screening indicating "fatty liver" or "hepatic fat infiltration"; 5.Those who sign the informed consent form, voluntarily participate in this project, and are able to complete the follow-up as required;
Exclusion criteria
Exclusion criteria: 1.Suffering from malignant tumors or having a history of malignant tumors within the past 5 years prior to screening; 2.Currently known to have active or recurrent severe infections such as tuberculosis; 3.Patients with serious diseases of important organ systems such as heart, brain, lungs, liver, kidneys, and blood, who are deemed unsuitable for participation in this study by the researchers; 4.Suffering from acute and chronic liver, gallbladder, and pancreatic diseases, including but not limited to: acute cholecystitis and cholangitis, biliary obstruction, primary sclerosing cholangitis, liver failure (Child Pugh B or C grade), acute pancreatitis; 5.There are other inflammatory skin diseases that may interfere with the efficacy evaluation, including but not limited to psoriasis, para psoriasis, eosinophilic dermatitis, seborrheic dermatitis, contact dermatitis, etc; 6.Received systemic immunosuppressive therapy such as glucocorticoids, Tripterygium wilfordii, cyclosporine, methotrexate, or JAK inhibitors (such as Upatinib, Abxitinib, Aimaxitinib, etc.) within 4 weeks prior to the first treatment in the study, or received biologics (such as Dupilumab, Prezimumab, and Omalizumab, etc.) within 3 months of treatment; 7.Within the past 4 weeks, have used antimicrobial drugs, probiotics/biologics, and treatments that regulate gut microbiota, as well as other drugs that have a significant impact on gut microbiota; 8.Known allergy to ursodeoxycholic acid or any of its excipients; 9.Currently in use or unable to discontinue drugs that may significantly affect blood lipid levels during the study period (such as beta, statins, niacin, etc.), except for lipid-lowering drugs that have been stably used for at least 3 months before screening and are planned to maintain the same dosage during the study period; 10.History of alcohol or drug abuse, researchers believe may affect compliance or increase risk; 11.Pregnant and lactating women; 12.The patient is currently participating in other clinical trial studies; 13.Any researcher who deems it inappropriate to participate in this trial for other reasons;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change in EASI score from baseline (V0 visit) to week 12 (V3 visit);Absolute and relative changes (%) in fasting lipid parameters from baseline (V0 visit) to week 12 (V3 visit); | — |
Secondary
| Measure | Time frame |
|---|---|
| EASI-50/75 response rate at weeks 4, 8, and 12;Change in skin lesion scores including SCORAD, IGA, NRS, BSA, and DLQI at baseline, week 4, week 8, and week 12;Change in serum liver enzymes (including ALT, AST, ?-GT) from baseline to week 4, week 8, and week 12;Change in fasting serum lipids and GLP-1 levels at baseline and week 12;Change in blood routine parameters and inflammatory cytokines (IL-4, IL-13, IL-17, IL-22, TNF-a, IL-6) from baseline to week 4, week 8, and week 12;Absolute change in liver fat content (UDFF value) from baseline (V0 visit) to week 12 (V3 visit);Change in serum total IgE levels and skin microbiota composition at baseline and week 12; | — |
Countries
China
Contacts
Public ContactLi Wei
Huashan Hospital, Fudan University
Outcome results
None listed