drugset / Trial / NCT07162896

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

NCT07162896

Phase 3 Not yet recruiting 66 enrolled Shalamar Institute of Health Sciences
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

EvaluationDrugModalityDoseRoute
Comparator Crisaborole Small molecule 2 % Topical
Comparator Tacrolimus Small molecule 0.1 % Topical

Indications