Atopic dermatitis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 18-65 years, both genders; 2. Diagnosed with atopic dermatitis according to Williams criteria; 3. Moderate atopic dermatitis (SCORAD score 25 <= score <= 50); 4. At least one large target lesion with a diameter of 1 to 5cm is located on the limbs or trunk; 5. Subjects had intact skin on the flexed side of one forearm and the extensor side of one calf, without any scar, injury and other influencing evaluation factors; 6. Subject's willingness to use the test article to the subject as directed by the physician throughout the study; 7. Subject does not use other equivalent throughout the study; 8. Ethical requirements were met and the subjects gave their own informed consent.
Exclusion criteria
Exclusion criteria: 1. Presence of a cutaneous infestation of the affected area; 2. Those with acute onset with erosion, exudation, secondary infection; 3. Lesions less than 1% and more than 10% of the total body area; 4. Currently other active inflammatory skin diseases, commonly cosmetic contact dermatitis CD, chronic simple lichen, psoriasis, enteropathic acral dermatitis, scabies, etc; 5. Those who had used topical glucocorticoids, topical calcineurin inhibitors, or topical PDE4 inhibitors within 1 week before treatment; 6. Had used phototherapy, systemic glucocorticoids, or immunosuppressive agents (e.g., cyclosporine, azathioprine, or immunoglobulins, etc.) within 4 weeks before treatment; 7. Subject discontinued therapy with biologics (durvalumab, omalizumab) for less than 12 weeks by system; 8. Malignant tumors, chronic systemic diseases (e.g., diabetes, hypothyroidism) or other acute and chronic infection subjects; 9. Allergic to the test medication or skin care products of this study; 10. Pregnant and lactating women, or those who are fertile and unwilling/unable to use effective contraception; 11. Have participated or are currently participating in other clinical investigators within three months; 12. Have any history of diseases (e.g., severe mental disorder, cognitive dysfunction, substance abuse or addiction, etc.) that may affect protocol adherence; 13. Patients for whom the investigator judged it inappropriate to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in water content of stratum corneum and transepidermal water loss rate on the 21st and 42nd days compared with baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in skin pH, epidermal erythema, and epidermal oil content on day 21 and 42 compared with baseline;Changes in SCORing Atopic Dermatitis (SCORAD) scores on day 21 and 42 compared with baseline;Changes in Eczema Area and Severity Index (EASI) scores on day 21 and 42 compared with baseline;Changes in pruritus Visual Analogue Scale (VAS) scores on days 21 and 42 compared with baseline;Changes in Dermatology Life Quality Index (DLQI) scores on days 21 and 42 compared with baseline;Product satisfaction questionnaire score; | — |
Countries
China
Contacts
Huashan Hospital of Fudan University