Atopic Dermatitis
Conditions
Interventions
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with 3 months =5% (excluding scalp area) and suitable for topical therapy; 4. In the baseline period and screening period, the IGA score is 2 or 3 points; 5. The condition is stable as assessed by the investigator, and there is no spontaneous improvement or rapid deterioration; 6. Subject's parent/legal guardian fully understands the content of the trial, voluntarily participates in the trial, has signed the informed consent form, and is willing and able to comply with all planned visits, treatment plans, laboratory tests, and other study procedures.
Exclusion criteria
Exclusion criteria: 1.There is a history of abnormalities in the musculoskeletal system, nervous system, mental system, endocrine system, circulatory system, respiratory system, digestive system, urinary system, reproductive system, immune system, or currently has any of the above diseases, and the researcher deems it to have clinical significance; 2.Having any clinically significant skin disease (including active or potentially recurrent non-atopic skin diseases and/or known hereditary skin diseases overlapping with atopic dermatitis, such as Netherton syndrome); 3.Birth weight < 2 kg or being a premature infant (defined as gestational age less than 37 weeks); 4.The creatinine clearance rate calculated based on age is below the lower limit of the normal range (LLN), or the serum creatinine level is above the upper limit of the normal range (ULN); the aspartate aminotransferase (AST) or alanine aminotransferase (ALT) value exceeds the upper limit of the normal range (ULN); 5.Human immunodeficiency virus infection, active hepatitis C virus infection (anti-HCV positive), positive Treponema pallidum antibody, or positive hepatitis B surface antigen (HBsAg); 6.Those who are allergic to the active ingredients or excipients of the investigational drug; 7.Subjects who have participated in any other drug clinical trials within 3 months prior to the first administration; 8.Previously treated with benvitimod cream; 9.A history of active airway disease that previously required systemic glucocorticoid treatment by Benwei; 10.Those with chronic or acute systemic or superficial infections and who have used systemic or topical antibacterial or antifungal agents within one week before the baseline visit; 11.Those who have received systemic biologic agents known to affect atopic dermatitis (such as dupilumab) within 5 half-lives before the baseline visit; 12.Those who have received ultraviolet phototherapy or systemic atopic dermatitis treatment (such as systemic glucocorticoids, immunosuppressants, oral Janus kinase inhibitors, etc.) within 4 weeks before the baseline visit; infants and young children who are being breastfed and whose mothers require high-dose systemic glucocorticoids or systemic immunotherapy, or are using other drugs that may be transmitted through breast milk and may alter the course of atopic dermatitis in infants and young children; 13.Those who received local treatment for atopic dermatitis within 2 weeks before the baseline visit (including topical glucocorticoids, calcineurin inhibitors such as pimecrolimus, phosphodiesterase 4 inhibitors such as crisaborole, Janus kinase inhibitors such as ruxolitinib, zinc oxide, tar preparations, etc.); or infants and young children are being breastfed, and the mother needs to use potent topical glucocorticoids; 14. Participated in other studies involving the investigational drug within 30 days prior to the baseline/Day 1 and/or during the study participation period; 15. Any planned surgery or medical procedure that will overlap with the study participation period from the screening stage until the final visit on Day 35 after the baseline; 16. Have received any type of cancer treatment (except for squamous cell carcinoma, basal cell carcinoma or skin carcinoma in situ that was cured solely by cryosurgery or surgical excision); 17. Subjects with skin lesions on the limbs (below the wrists and ankles) or with skin lesions within 2 cm of the mouth; 18. The researcher believes that the subject has any other factors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety capability evaluation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of subjects achieving an IGA of 0 or 1 with at least a 2-point decrease from baseline (IGA response rate);Percentage of subjects with IGA of 0 or 1;Percentage of subjects with 50% EASI reduction (EASI 50 Response Rate);The percentage of subjects achieving a 75% reduction in EASI on days 7, 14, and 28 of treatment (EASI 75 response rate);Percentage of subjects with a 90% EASI reduction (EASI 90 Response Rate);Change from baseline in BSA score;Change from baseline in POEM score; | — |
Countries
China
Contacts
Public ContactJianzhong Zhang; Cheng Zhou
Peking University People's Hospital
Outcome results
None listed