Atopic dermatitis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients who meet the Chinese diagnostic criteria for atopic dermatitis as defined in the Chinese Guidelines for the Diagnosis and Treatment of Atopic Dermatitis (2020 Edition); 2.Affected sites include the hands and feet; 3.Age >= 18 years at the baseline visit, with no gender restriction; 4.Inadequately controlled with oral antihistamines and topical medications; 5.Voluntary participation in the study and signing of the written informed consent form.
Exclusion criteria
Exclusion criteria: 1.Hypersensitivity to the active ingredient of ciclosporin; 2.Pregnant or breastfeeding women; 3.Patients currently participating in or planning to participate in other interventional studies during the study period; 4.Any disease that, in the investigator's opinion, may interfere with the patient's participation in the study, such as: concomitant hepatic or renal insufficiency; active infection; uncontrolled hypertension; coexisting malignancy or severe organic disease; or other comorbidities that could foreseeably affect the patient's ability to complete scheduled visits and assessments; 5.Other factors that, in the investigator's opinion, make the patient unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving EASI 75 and HECSI-75 at 8 weeks; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes from baseline in SCORAD, DLQI, ADCT, PP?NRS, BSA, and HECSI scores;Proportion of patients achieving EASI 75 at weeks 2, 4, and 12;proportion of patients achieving ESAI 90 at weeks 2, 4, 8, and 12;Proportion of patients achieving IGA 0/1 at week 12;Changes in serum eosinophil count and serum total IgE levels; | — |
Countries
China
Contacts
The First Affiliated Hospital of Guilin Medical University