Atopic dermatitis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or older, no restriction on gender; 2. Diagnosed with atopic dermatitis (AD) per the Hanifin & Rajka criteria; 3. Eczema Area and Severity Index (EASI) score <=6, Validated Investigator Global Assessment for Atopic Dermatitis (vIGA AD) score <=2, and the affected Body Surface Area (BSA) of AD <5%; 4. Peak Pruritus Numerical Rating Scale (PP NRS) score <4; 5. Able to fully understand the study purpose, refrain from all AD targeted medications throughout the study period, avoid topical products of the same category as the investigational product on lesion sites, voluntarily participate and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. In the acute flare phase complicated with erosion, exudation or secondary infection; 2. Received topical treatments at the target lesion within 2 weeks prior to enrollment, including antifungals, calcineurin inhibitors, glucocorticoids and antihistamines; 3. Received systemic antifungals, glucocorticoids, immunosuppressants or antihistamines within 4 weeks prior to enrollment; 4. With severe cardiovascular or nervous system impairment, or complicated with uncontrolled severe diabetes, malignant tumor, tuberculosis, psychiatric disorders or other diseases deemed ineligible for enrollment by the investigator; 5. Suffering from other dermatoses apart from AD at the target test area; 6. Confirmed hypersensitivity to the investigational product; 7. Females planning pregnancy within 6 months, pregnant or breastfeeding; 8. Enrolled in another interventional clinical trial within the preceding 4 weeks; 9. Subjects otherwise considered unsuitable for study participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Eczema Area and Severity Index (EASI); | — |
Secondary
| Measure | Time frame |
|---|---|
| Eczema Area and Severity Index (EASI) scoring was analyzed separately by affected area and clinical symptoms including erythema, induration (edema)/papules, excoriation and lichenification.;Transepidermal Water Loss (TEWL);Peak Pruritus Numeric Rating Scale (PP-NRS);Patient Satisfaction Score;Dermatology Life Quality Index (DLQI);Investigator's Subjective Assessment;Investigator's Global Assessment (IGA);Stratum Corneum Moisture Content; | — |
Countries
China
Contacts
Affiliated hangzhou first people's hospital, zhejiang university school of medicine