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NOT YET RECRUITING
NCT07162896
PHASE3

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

Sponsor: Shalamar Institute of Health Sciences

View on ClinicalTrials.gov

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

Interventions

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.

Locations (1)

Shalamar Hospital Lahore

Lahore, Punjab Province, Pakistan