Atopic dermatits
Conditions
Interventions
Group A:Crisaborole Bid, then Qod in Maintenance Period
Group B:Crisaborole Bid, then Biw in Maintenance Period
Sponsors
Beijng Children's Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
2 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1. Has a clinical diagnosis of AD according to the criteria of Hanifin and Rajka; 2. Has an EASI score =2 years older and <18 years older at the Screening visit/time of informed consent/assent; 4. Willing and able to comply with scheduled visits, treatment plan, and other study procedures, willing to sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Has AD with acute erosion, exudation, and secondary infection; 2. Has participated in other clinical studies within 3 months or is participating in other clinical studies now; 3. Has received any topical treatment, including Calcineurin inhibitors (topical tacrolimus or pimecrolimus), glucocorticoids, and topical antihistamines within 14 days; 4. Has received nonsteroidal immunosuppressants (such as cyclosporine and methotrexate) or UV treatment, systematic glucocorticoid, and systematic antihistamines within 4 weeks. 5. Has severe systemic diseases, such as severe heart, liver, kidney diseases or immune system injury diseases (such as lymphoma, AIDS, Wiskott Aldrich syndrome) or malignant tumors history; 6. Has dermatological conditions that overlap with AD; 7. Is allergic to Crisaborole or any Crisaborole ingredients; 8. Has poor compliance, or is unable to comply with scheduled visits, and treatment plan.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Investigator’s Static Global Assessment (ISGA);Recurrence rate;Mean recurrence time; | — |
Secondary
| Measure | Time frame |
|---|---|
| Children’s Dermatology Life Quality Index (CDLQI) ;Infant’s Dermatitis Quality of Life Index (IDQOL);Pruritus Numerical Rating Scale;Eczema Area and Severity Index (EASI);Sleep impact Numerical Rating Scale;stratum corneum hydration;Transepidermal water loss (TEWL);PH; | — |
Countries
China
Contacts
Public ContactLin Ma
Beijing Children's hospital, Capital medical university
Outcome results
None listed