Overview

Crisaborole 2% Versus Tacrolimus 0.1% in Children With Mild to Moderate Atopic Dermatitis

Status:
NOT_YET_RECRUITING
Trial end date:
2027-06-01
Target enrollment:
Participant gender:
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.
Phase:
PHASE3
Details
Lead Sponsor:
Shalamar Institute of Health Sciences