Atopic Dermatitis
Conditions
Interventions
Abrocitinib 100mg:Administer 100 mg of abrocitinib orally once daily to the patient.
Abrocitinib 200mg:Administer 200 mg of abrocitinib orally once daily to the patient.
Dupixent 300mg:Administer 300 mg of Dupixent by injection every two weeks to the patient.
Sponsors
Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical College
Eligibility
Sex/Gender
All
Age
12 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1.Age =12 years, regardless of gender; 2.Patients diagnosed with atopic dermatitis (AD) based on the Hanifin-Rajka diagnostic criteria, excluding infections, tumors, and other connective tissue diseases. 3.During the screening period, patients must meet at least one item in each of the following three dimensions and initiate systemic therapy: (1)High severity of lesions/itching (moderate to severe): ?Investigator’s Global Assessment (IGA) score =3 (0-4 scale); ? Eczema Area And Severity Index (EASI) >15; ? Scoring Atopic Dermatitis Index (SCORAD) >40; ?Body Surface Area (BSA) with refractory lesions >10%; ?IGA × BSA >130; (2)Lack of response or contraindications to topical treatment: ?Unsatisfactory response to topical treatments (medium to high potency corticosteroids for 4 weeks, or ultra-high potency corticosteroids for 2 weeks) or phototherapy; ?Contraindications/no response/ineffectiveness/adverse reactions to non-systemic treatment regimens; ?Current treatment relapse rate >6 times/year; (3)Impact on normal daily activities despite appropriate treatment regimens: ?Dermatology Life Quality Index (DLQI) >10; ?Itch Visual Analogue Scale (VAS) or Numeric Rating Scale (NRS) score >6; ?Relative sleep disturbance due to lesions or itching; 4.Signed informed consent, voluntarily participating in this project, and able to complete follow-up as required.
Exclusion criteria
Exclusion criteria: (1)Presence of other inflammatory skin diseases that may interfere with efficacy evaluation, including but not limited to psoriasis, parapsoriasis, eosinophilic dermatitis, seborrheic dermatitis, and contact dermatitis. (2)Severe diseases of major organ systems such as the heart, brain, lungs, liver, kidneys, or blood, which, in the investigator’s opinion, make the patient unsuitable for participation in this study. (3)Use of systemic and topical antimicrobial drugs and other medications significantly affecting skin microbiota within the past 4 weeks. (4)Congenital immunodeficiency or congenital immune suppression. (5)Pregnancy, lactation, or inability to effectively use contraception in women. (6)Participation in other interventional clinical studies within the past 2 months. (7)Substance abuse, alcoholism, or mental disorders that prevent cooperation or adherence to treatment, or predict poor compliance. (8)Other conditions that the investigator deems unsuitable for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PP-NRS4;PtGA0/1;EASI-75; | — |
Secondary
| Measure | Time frame |
|---|---|
| IGA;Total cost of treatment;EASI;DLQI;SCORAD;BSA;PP-NRS4;PP-NRS;Relapse rate; | — |
Countries
China
Contacts
Public ContactXu Yao
Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical College
Outcome results
None listed