Atopic dermatitis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 2 months to 2 yeras, atopic dermatitis patients, male or female; 2. Diagnosed childhood atopic dermatitis according to Williams criteria; 3. Mild to moderate atopic dermatitis (defined as SCORAD score 0 < score <= 50); 4. IgA score of 2 (mild) or 3 (moderate); 5. At least one lesion that occurred on the face served as a target lesion; 6. Subject guardian willingness to use subjects as directed by physician throughout the study; 7. Subjects uniformly did not use other equivalent throughout the study; 8. Ethical requirements were met and the child's legal guardian voluntarily agreed to participate in the clinical study.
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. Those with more than 10% total body lesion area; 4. Currently, there are other active inflammatory skin diseases, commonly cosmetic contact dermatitis, chronic simple lichen, psoriasis, enteropathic acral dermatitis, scabies, acne, etc.; 5. Had used antihistamines within 2 weeks before enrollment; 6. Those who had been treated with topical medications (e.g., glucocorticoids, calcineurin inhibitors, PDE4 inhibitors) within 1 week prior to enrollment; 7. Had used phototherapy, systemic glucocorticoids, immunosuppressive agents (e.g., cyclosporine, azathioprine, or immunoglobulins, etc.) within 4 weeks before enrollment; 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. Known allergy to ingredients contained in moisturizing essence cream or denaturation cream for this investigational product; 11. Have participated in or are currently attending other clinical investigators within three months; 12. Patients for whom the investigator judged it inappropriate to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate: proportion of patients with IgA score = 0 or 1 at the end of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| SCORing Atopic Dermatitis, SCORAD;Dermatology Life Quality Index, DLQI;Itch Visual Analogue Scale (VAS) score;Rate of ad relapse and relapse interval;Skin barrier parameters;Skin microecological indexes;Evaluation of the product by the subject's legal guardian; | — |
Countries
China
Contacts
Shenzhen Maternity and Child Health Hospital