Atopic Dermatitis
Conditions
Interventions
Control group:Placebo
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
2 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Age = 2 years old, the patient was clinically diagnosed as atopic dermatitis(Hanifin and Rajka criteria); 2.Gender unlimited; 3.The BSA is 5 to 35% (excluding scalp), and topical therapy is applicable; 4.At baseline and screening period, IGA=3; 5.The disease was stable as assessed by the investigators, with no spontaneous improvement or rapid deterioration; 6.Women of childbearing age with reproductive potential (including women who had already menarche and did not meet the criteria for no reproductive potential) had a negative blood pregnancy test at baseline screening and agreed to use effective contraception during the study. Female subjects with no reproductive potential must meet at least one of the following criteria:?Postmenopausal status, defined as absence of menstruation for at least 12 consecutive months without other pathological or physiological causes;?Have undergone a hysterectomy and/or bilateral oophorectomy and have a documented history;?Medically confirmed ovarian failure; 7.Subjects fully understand the content of the study, voluntarily participate in the study, have signed informed consent.
Exclusion criteria
Exclusion criteria: 1.People with severe diseases of central nervous system, cardiovascular system, kidney, liver, digestive tract, respiratory system, metabolism and skeletal muscle system; 2.Patients with acute or chronic psychiatric disorders, including active suicidal ideation or behavior or related laboratory abnormalities within the past year, or that may interfere with study medication or interpretation of study findings, who were judged by the investigator to be unsuitable for participation in the study; 3.Liver function serum alanine aminotransferase (ALT), aspartate aminotransferase (AST) > 2 times the upper limit of normal, or renal function serum creatinine higher than 1.5 times the upper limit of normal; 4.Have a history of cancer or have been treated for any type of cancer within the last 5 years (except for squamous cell carcinoma, basal cell carcinoma, or skin carcinoma in situ that was cured by cryotherapy or surgical resection); 5.Human immunodeficiency virus infection, hepatitis C virus infection active period (anti-HCV positive), hepatitis B virus infection active period (HBV-DNA > 2000 IU/mL or 104 copies /ml) or treponema pallidum antibody positive; 6.Women who are pregnant, lactating, or planning to become pregnant; 7.People who are known to be allergic to the active ingredient or excipient of the investigational drug; 8.Participants who have participated in clinical trials of any other drug within 3 months prior to initial dosing; 9.People who regularly use Chinese herbs or sedatives, sleeping pills, tranquilizers and other addictive drugs; 10.Have other conditions that may interfere with the clinical evaluation of atopic dermatitis and/or have a history of other severe skin conditions other than atopic dermatitis; 11.People who have used benvermod cream in the past; 12.Patients with chronic or acute systemic or superficial infections requiring the use of systemic or topical antimicrobials or antifungals within 1 week prior to baseline visit; 13.Patients treated with systemic biologics known to affect atopic dermatitis (e.g., dupriuzumab) during the 5 half-lives prior to baseline visit; 14.Those who had received UV phototherapy or systemic atopic dermatitis treatment (e.g., systemic glucocorticoids, immunosuppressants, oral Janus kinase inhibitors, etc.) within 4 weeks prior to baseline visit; 15.Patients who had received topical anti-atopic dermatitis treatment within 2 weeks prior to baseline visit (including topical corticosteroids, calcineurin inhibitors such as pimelimus, phosphodiesterase 4 inhibitors such as creborol, Janus kinase inhibitors such as rucotinib, zinc oxide, tar, etc.); 16.Subjects may not be able to complete the study for other reasons or may not be considered appropriate by the investigator to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| EASI reduction of 75% of subjects (EASI 75 response rate); | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of subjects with an IGA of 0 or 1 and a decrease of at least 2 points from baseline(IGA response rate);EASI reduction of 90% of subjects (EASI 90 response rate);Percentage change in EASI from baseline;Percentage change in BSA from baseline;Changes in PP-NRS from baseline for subjects aged 12 years and older Percentage conversion;For subjects aged 12 years and older, baseline PP-NRS score =4 Percentage of subjects with = grade 4 improvement after treatment (PP-NRS 4 response rate); | — |
Countries
China
Contacts
Public ContactJianzhong Zhang
Peking University People's Hospital
Outcome results
None listed