Atopic Dermatitis
Conditions
Interventions
Control group:Placebo
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years old, gender unlimited; 2. The patient was clinically diagnosed as atopic dermatitis (according to the diagnostic criteria of the 2020 edition of Chinese Guidelines for the Diagnosis and Treatment of Atopic Dermatitis), and the course of the disease was >= 6 months, with eczema area and severity index (EASI) = 3; 4. Subjects fully understand the content of the study, voluntarily participate in the study, have signed informed consent, and are willing and able to follow planned visits, treatment plans, laboratory examinations, and other study procedures.
Exclusion criteria
Exclusion criteria: 1. Skin lesions limited to the head, neck, hands and feet; 2. Liver function ALT or AST >= 3 x ULN, renal function BUN or Cr > 1.5 x ULN; 3. Suffering from obvious cardiovascular, respiratory, gastrointestinal, liver, kidney, blood, nervous and psychological diseases, and the condition is unstable or not well controlled; 4. Suffer from any systemic diseases or other active skin diseases that may affect the evaluation of test results, or have scars, fetal spots, tattoos, etc. on the affected areas that will affect the evaluation of skin lesions; 5. Patients with malignant tumors; 6. Subjects who suffer from severe concomitant diseases, may need to be given systemic hormone therapy or other interventions, affect research participation or require frequent active monitoring (such as unstable chronic asthma); 7. Patients with clear skin local bacterial, viral and fungal infections; 8. Suffering from mental illness, or other reasons that may interfere with participating in the experiment; 9. Those who are known to be allergic to any component of the test drug; 10. Those who have severe hypersensitivity to food, drugs, insect venom or rubber; 11. Women who are pregnant, lactating, or planning to become pregnant; 12. Alcoholism, drug abuse and known drug dependence; 13. The following therapists were used within the following limited time before enrollment: (1) Topical drug therapy (such as glucocorticoids, calcineurin inhibitors, tacrolimus, PDE-4 inhibitors, etc.) has been used within 2 weeks; (2) Systemic immunotherapy (such as glucocorticoids, methotrexate, JAK inhibitors, cyclosporine, etc.) has been used within 4 weeks; (3) Received biological agents for atopic dermatitis (such as IL-4 inhibitors, IL-13 inhibitors, etc.) within 4 weeks (or 5 half-lives, whichever is longer); (4) Received ultraviolet therapy and photochemotherapy within 4 weeks; 14. Participated in clinical trials of other drugs or medical devices within 4 weeks; 15. Subjects considered by other researchers to be unsuitable for participating in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants with Investigator Global Assessment (IGA) of 0 (complete removal) or 1 (nearly complete removal) and a decrease of >= 2 points score from Baseline to Week 8;Proportion of participants with recurrence and the time of first recurrence of 1.0% Benvitimod cream;Proportion of participants of IGA = 0 or 1 was achieved after retreatment 8 weeks in recurrence subjects;Incidence of TEAE and SAE; | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage decline in Eczema Area and Severity Index (EASI) score from Baseline to Week 8;Proportion of participants with >= 75% improvement in Eczema Area and Severity Index (EASI) score from Baseline to Week 8;Proportion of participants with >= 90% improvement in Eczema Area and Severity Index (EASI) score from Baseline to Week 8;Proportion of participants with >= 50% improvement in Eczema Area and Severity Index (EASI) score from Baseline to Week 8;Proportion of participants with >= 3 score improvement in Pruritus Visual Analogue Scale (VAS) from Baseline to Week 8;Overall EASI improvement rate and its changes with time from Baseline to Week 8;The average IGA decrease and its changes with time from Baseline to Week 8;The average DLQI decrease and its changes with time from Baseline to Week 8;The average BSA decrease and its changes with time from Baseline to Week 8;The average Pruritus Visual Analogue Scale (VAS) decrease and its changes with time from Baseline to Week 8;Number of recurrences in recurrence participants;Proportion of participants with >= 50% improvement in Eczema Area and Severity Index (EASI) score after retreatment 8 weeks in recurrence subjects;Incidence of AE/ADR at each visit during medication;Incidence of clinical abnormalities such as laboratory tests and electrocardiogram (ECG); | — |
Countries
China
Contacts
Public ContactShen Juan
Guangdong Zhonghao Pharmaceutical Co., Ltd.
Outcome results
None listed