Atopic dermatitis
Conditions
Interventions
Test group :The dose is estimated according to BSA
Control group:The placebo dose is estimated according to BSA
Sponsors
Huashan Hospital affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Subjects voluntarily participated in clinical trials and signed ICF; 2. The age of screening was 18-65 years old (including the cut-off value), regardless of gender; 3. Meet at least 3 major features and 3 minor features of AD Hanifin-Rajka diagnostic criteria; 4. IGA score of 2-3 (mild to moderate) at screening; 5. The EASI score at screening was 1.1-21 (mild to moderate); 6. History of AD = 1 year at Screening (evidence of a prior diagnosis of AD or eczema was required); 7. AD lesion area (excluding scalp lesions, but including facial lesions) 3%=BSA=20% at screening; 8. The willingness of fertile men and women to use effective contraceptive methods, including abstinence, condoms, intrauterine devices, etc., from the date of signing ICF to 3 months after the last administration of MDI-1228_mesylate gel; 9. Subjects can communicate well with investigators and understand and comply with the requirements of this trial.
Exclusion criteria
Exclusion criteria: 1. Patients with other skin diseases or lesions caused by other systemic diseases that may affect the clinical evaluation of AD, or those with large tattoos, birthmarks, skin scars, and skin perforations in the lesion area of AD that may affect the evaluation of skin lesions; 2. Clinically significant active systemic/local infections at the time of screening, including but not limited to AD secondary infections, local bacterial infections, local viral infections, and local fungal infections (Note: patients can be re-screened after the infection has resolved); 3. Patients with a history of herpes simplex, herpes zoster, cytomegalovirus, or human herpesvirus (EBV) infection 4 weeks before randomization were screened; 4. Hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus (HIV) antibody and treponema pallidum specific antibody (TPPA) were positive in the screening period; 5. Accompanied by serious diseases of the central nervous system, cardiovascular system, respiratory system, liver system, kidney system, gastrointestinal system, urinary system, endocrine system or blood system, and the investigator believes that it may confound the study results or affect the safety of the subjects; 6. Diagnosis of malignant tumor or history of malignant tumor; 7. Unable to communicate or cooperate with medical staff due to neurological or mental illness or language barrier; 8. ALT, AST and GT during the screening period; 2 times ULN or serum creatinine > 1.5 times of ULN, or other abnormal laboratory test results that are judged by the investigators to be clinically significant and may have an impact on the evaluation of this trial; 9. Use of sedating antihistamines within 2 weeks (or 5 elimination half-life times, whichever is longer) before screening or need to continue the use of sedating antihistamines during the study (except for stable nonsedating antihistamines used for =7 days before randomization were screened and maintained on their original regimen during the study); 10. Use of any CYP2C8, CYP3A enzyme inducer or inhibitor within 2 weeks (or 5 elimination half-lives, whichever is longer) before randomization were screened; 11. Systemic antiinfective therapy within 2 weeks (or five elimination half-lives, whichever is longer) before randomization were screened; 12. Use of topical agents with AD therapeutic effects within 2 weeks (or 5 elimination half-lives, whichever is longer) before randomization , Including, but not limited to, topical glucocorticoids, topical Janus kinase inhibitors, topical calcineurin inhibitors, PDE-4 inhibitors, traditional Chinese medicine or natural drugs and other drugs [zinc oxide oil (paste), black bean distillation oil ointment]; 13. Systemic therapy known or likely to affect AD (including but not limited to glucocorticoids, Janus kinase inhibitors, immunosuppressants, immunomodulators, traditional Chinese medicine or natural medicines with therapeutic effects on AD) within 4 weeks (or 5 elimination half-life times, whichever is longer) before randomization ; 14. Received sunbathing, phototherapy (including ultraviolet therapy, photochemotherapy, etc.) for AD treatment within 4 weeks before randomization were screened; 15. Biologic therapy for AD or other immune diseases (including, but not limited to, intravenous immunoglobulin) within 12 weeks (or five elimination half-lives, if the longer) before randomization were screened; 16. Known or possible allergic re
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment Emergent Adverse Event;Serious Adverse Event;Treatment Emergent Adverse Event during topical skin treatment;Physical Examination;Vital signs;A 12-lead electrocardiogram was obtained;Laboratory test results; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes from baseline in eczema area and Severity Index scores;Changes from baseline in investigator global scores;Difference and percentage decrease from baseline in the Peak Pruritus Numeric Rating Scale;AUC0-t,ss;Cmax,ss;t1/2,ss;Tmax,ss; | — |
Countries
China
Contacts
Public ContactXu Jinhua
Huashan Hospital affiliated to Fudan University
Outcome results
None listed