drugset / Trial / NCT07162896
Crisaborole 2% Versus Tacrolimus 0.1% in Children With Mild to Moderate Atopic Dermatitis
RandomizedParallel-groupOpen-labelTreatment
Summary
This randomized, open-label, parallel-group study will compare the efficacy and safety of Crisaborole 2% ointment and Tacrolimus 0.1% ointment in children with mild to moderate atopic dermatitis. A total of 66 participants will be randomized (1:1) to receive either Crisaborole or Tacrolimus, applied twice daily to affected areas for 28 days. Primary endpoint is proportion of participants achieving Investigator's Static Global Assessment (ISGA) success (clear/almost clear with ≥2-point improvement from baseline) at Day 28. Safety assessments include adverse events and local application site reactions.
Timeline
- Start
- 2026-06
- Primary completion
- 2027-01
- Completion
- 2027-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Crisaborole | Small molecule | 2 % | Topical |
| Comparator | Tacrolimus | Small molecule | 0.1 % | Topical |