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Crisaborole 2% Versus Tacrolimus 0.1% in Children With Mild to Moderate Atopic Dermatitis
Sponsor: Shalamar Institute of Health Sciences
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.
Official title: Efficacy and Safety of Crisaborole 2% Versus Tacrolimus 0.1% in Children With Mild to Moderate Atopic Dermatitis
Key Details
Gender
All
Age Range
2 Years - 18 Years
Study Type
INTERVENTIONAL
Enrollment
66
Start Date
2026-06
Completion Date
2027-06
Last Updated
2025-09-09
Healthy Volunteers
No
Conditions
Interventions
Crisaborole 2%
Apply thin layer to affected skin daily for 28 days.
Tacrolimus 0.1%
Apply thin layer to affected skin daily for 28 days.
Locations (1)
Shalamar Hospital Lahore
Lahore, Punjab Province, Pakistan