NCT07162896

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

Efficacy and Safety of Crisaborole 2% Versus Tacrolimus 0.1% in Children With Mild to Moderate Atopic Dermatitis

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Shalamar Institute of Health Sciences · Academic / Other
• Sex: All
• Age: 2 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atopic Dermatitis
• Atopic Dermatitis (AD)

Interventions

Type	Name	Description
DRUG	Crisaborole 2%	Apply thin layer to affected skin daily for 28 days.
DRUG	Tacrolimus 0.1%	Apply thin layer to affected skin daily for 28 days.

Timeline

• Start date: 2026-06-01
• Primary completion: 2027-01-01
• Completion: 2027-06-01
• First posted: 2025-09-09
• Last updated: 2025-09-09

Locations

1 site across 1 country: Pakistan