Atopic dermatitis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 12-65 years, both genders; 2. Diagnosed with atopic dermatitis according to Williams criteria; 3. Mild atopic dermatitis (SCORAD score 0 < score <= 24); 4. At least one larger lesion area of 2 to 10 cm diameter was used as the target lesion site; 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, 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. Those who had used antihistamines within 2 weeks before treatment; 7. Had used phototherapy, systemic glucocorticoids, or immunosuppressive agents (e.g., cyclosporine, azathioprine, or immunoglobulins, etc.) within 4 weeks before treatment; 8. Subject discontinued therapy with biologics (durvalumab, omalizumab) for less than 12 weeks by system; 9. Malignant tumors, chronic systemic diseases (e.g., diabetes, hypothyroidism) or other acute and chronic infection subjects; 10. Allergic to the test medication or skin care products of this study; 11. Pregnant and lactating women, or those who are fertile and unwilling/unable to use effective contraception; 12. Have participated or are currently participating in other clinical investigators within three months; 13. Have any history of diseases (e.g., severe mental disorder, cognitive dysfunction, substance abuse or addiction, etc.) that may affect protocol adherence; 14. 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 on the 14th and 28th days compared with baseline;Changes in transepidermal water loss (TEWL) rate on days 14 and 28 compared with baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in skin pH on days 14 and 28 compared with baseline;Changes in the amount of epidermal erythema on days 14 and 28 compared with baseline;Changes in skin oil content on days 14 and 28 compared with baseline;Changes in easi scores on days 14 and 28 compared with baseline;Change in Visual Analogue Scale (VAS) score of pruritus on days 14 and 28 compared with baseline;Changes in dermatology life quality index (DLQI) scores on days 14 and 28 compared with baseline;Product satisfaction questionnaire score;Dosage of external hormone on the 14th and 28th days; | — |
Countries
China
Contacts
Dermatology Hospital of Southern Medical University